Celgene

Celgene Seattle, WA, USA
Feb 19, 2020
Full time
Req #: Location: Seattle, Washington, United States Job Category: Clinical Operations Work Location: 400 Dexter Ave N. 98109 Organization: Biostatistics Employee Status: Full-time Job Type: Regular As our Principal Statistician (Cell Therapy CMC) you are responsible for providing statistical support to the Cell Therapy CMC teams. Serves as primary Biostatistician on multiple analytical and manufacturing process related activities. Participates in the development of protocols and statistical analysis plans. Performs statistical analysis, interprets statistical results, and participates in the preparation of study reports. Oversees the work of others that are performing any of the above listed tasks. May travel up to 10%. Responsibilities and Duties: Participate in protocol development; Calculate sample sizes and/or perform power calculations for proposed studies as well as for alternative designs to evaluate the costs and timelines of various scenarios; Propose methods for statistical analysis and write the statistical sections of study protocols; Experience with the statistical aspects of Analytical method development, qualification, validation, transfer, comparability and troubleshooting. Experience with the statistical aspects of Process development, characterization, comparability, PPQ and troubleshooting. Experience with the statistical aspects of translational development, stability analysis & shelf life determination and specification setting. Review programming and analysis specifications; Write statistical analysis plans; Perform statistical analyses of CMC data using JMP / SAS and other statistical software packages as necessary. Oversee the work of scientists / engineers that are performing statistical analyses of CMC data; Lead the study teams in the review, and discussion, of analysis plans; Interpret statistical results and present study findings to the teams, senior management, and in various external forums; Participate in organizing and writing results for primary publication; and Maintain project files that ensure adequate and clear documentation of statistical analyses. Other responsibilities as assigned. Quality Requirements: Play a key role in meeting cross-functional goals through commitment, quality standards, and a customer service orientation. Contribute to a work environment that fosters professionalism, mutual respect, teamwork, and collaboration. Knowledge, Skills, Abilities and Qualification Requirements: Master's degree or Ph.D. in statistics,Biostatistics, mathematics, or related field; 8+ years of prior experience in a CMC drug-development environment; Experience or training with a wide-range of skills including JMP/ SAS programming and other relevant statistical software such as Minitab and / or R, statistical methodology and theories, and analysis; Excellent computer skills in the following programs: MS Word, PowerPoint, and Excel; Experience writing technical documents, reports, and presentations; Ability to manage multiple and diverse issues; Key Competencies: Professionalism and customer service orientation Communication skills - written and verbal Planning, organizing and multi-tasking Prioritizing and time management Problem assessment and problem solving Information gathering and information monitoring Attention to detail and accuracy Flexibility, adaptability and teamwork About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene Summit, NJ, USA
Feb 19, 2020
Full time
Req #: Location: Summit, New Jersey, United States Job Category: Medical Work Location: 86 Morris Avenue 07901 Organization: Scientific Communication Employee Status: Full-time Job Type: Regular Manager, Scientific Communications Corporate Medical Affairs PREREQUISITES Scientific or Medical Degree (OCN, BS, MS, Pharm D, PhD, MD) required Publication experience required Relevant therapeutic background/clinical experience preferred Position Summary: As our Scientific Communications Manager, you will provide input and drive the global scientific communications plan for company products within specified therapeutic area. You support the efficient planning, tracking and timely dissemination of key data and demonstrates the ability to manage multiple projects. Other Responsibilities include: Establishes strong partnerships with medical thought leaders, investigators/authors, and internal cross-functional stakeholders. Accountable for the timelines and working closely with all key stakeholders to ensure expert input and overall quality of written, global communications, including but not limited to publications, abstracts, oral presentations, and publication summaries. Provides appropriate direction on all projects to medical communication agencies and consultants to support their timely and cost-effective development and demonstrates ability to provide clear, concise status updates to management and internal partners. Writes a significant amount of time and demonstrates the ability to interpret scientific/clinical data and develop quality publications. Applies disease-area and product expertise to a wide variety of cross-functional projects. Contributes significantly to publication planning process, in support of the Director, Scientific Communications. Core Responsibilities: Provides scientific/clinical direction, manages and delivers on global scientific communications plan Manages relationships with both internal and external stakeholders and ensures expert input during development of team deliverables Establishes strong partnership with global medical thought leaders, patient advocacy groups, and professional societies to drive current and future collaborations Develops and reviews manuscripts, abstracts, posters, slide presentations, and other documents to ensure appropriate evaluation and presentation of data, methodology, interpretation, and alliance with business objectives Demonstrates ability to effectively manage multiple projects simultaneously in a timely and cost-efficient manner and demonstrates ability to provide clear, concise status updates to management and internal partners Develops content and reviews slides for clarity, accuracy, and interpretation Demonstrates disease state expertise and knowledge of current medical and/or regulatory issues related to company products Serves as internal resource on molecule and/or disease state publications to support cross-functional strategies. Manages funds and resources appropriately Other Responsibilities: Conducts business in accordance with Celgene Values. Completes all assigned SOPs and training within designated timeframe and adheres to job-specific SOPs and work instructions Identifies and reports any adverse events (AEs) in accordance with Corporate policy and procedures Assists in the overall training of new Scientific Communications personnel and ensures key activities are incorporated as part of the training Attends external meetings and educational seminars to enhance therapeutic area knowledge and broaden pharmaceutical industry experience Skills/Knowledge Required : Ability to conceptually organize and analyze data, interpret, and synthesize complex clinical and non-clinical statistical reports to derive key outcomes and messages; ability to translate scientific and technical issues for diverse audiences, Experience or background in working within the pharmaceutical industry, awareness of compliance issues and guidelines around medical education and publications, Ability to work with multidisciplinary teams to ensure execution of deliverable successfully Excellent written, verbal and interpersonal communication skills Flexible, with positive attitude, strong ability to multi task, prioritize projects effectively and communicate at all levels within the company Some travel required to represent company at medical conferences, presentations, and other meetings About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene Berkeley Heights, NJ, USA
Feb 19, 2020
Full time
Req #: Location: Berkeley Heights, New Jersey, United States Job Category: Clinical Operations Work Location: 300 Connell Dr 07922 Organization: Biostatistics Employee Status: Full-time Job Type: Regular Responsibilities will include, but are not limited to, the following: Contribute to efficient study design, preparing statistical consideration sections and providing input into other protocol sections. Perform simulations for ED statistical innovative designs. Prepare statistical analysis plans including table shells. Analyze clinical trial data; work with programmers to provide tables, listings and graphs, including ad hoc validation. Maintain / upgrade home-grown ED Stats software with ED Bayesian Methods. Review, synthesize, interpret and report analysis results. Provide ad hoc data driven analyses. Provide statistical input for the preparation of final study reports and other required documents. Escalates issues to functional management as necessary. Makes recommendations or resolves technical, quality, and timeline issues. Skills/Knowledge Required: MS or Ph.D in Statistics. At least 2 years clinical drug development experience with a Master's degree; or no additional experience with a Ph.D. as a study statistician. 1 plus years statistical computing experience (e.g. SAS, R, or other statistical computing software) Knowledge of MS Office products (Word, Excel, PowerPoint) Demonstrated skill in statistical methodologies and data analysis, especially in Bayesian methods. Knowledge of clinical trial design concepts. Also knowledge of Bayesian innovative designs in ED Demonstrated ability to learn statistical regulatory requirements. Good interpersonal, communication, writing and organizational skills. Ability to work in a team environment with medical personnel, clinical monitors, data managers, programmers and medical writers. About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene Seattle, WA, USA
Feb 19, 2020
Full time
Req #: Location: Seattle, Washington, United States Job Category: Technical Development Work Location: 400 Dexter Ave N. 98109 Organization: Bioengineering Employee Status: Full-time Job Type: Regular Scientist, Gene Editing Process Development Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence, and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture. Celgene is developing clinical-stage, novel cellular immunotherapies based on two distinct and complementary platforms - Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body's immune system to treat cancer. Celgene is seeking an enthusiastic, self-driven individual to join the viral vector and gene editing process development team. The viral vector and gene editing team develops the processes and technology underpinning critical raw materials used in the manufacturing of engineered T cells. The primary focus of this Scientist will be to ensure the development of GMP manufacturing for site-directed gene editing components including guide RNAs and enzymes. This position will be responsible for providing technical subject matter expertise with internal and external development and manufacturing collaborators including supporting deviation closure, ensuring the processes meet qTPP and specifications, and contributing to comparability assessments due to any process changes. This Scientist will also contribute to wet lab experimental design and execution for viral vector production process development. Responsibilities: Support technology development and on-going activities with external collaborators and service providers (CMOs, CROs) Work with internal collaborators to determine nucleic acid and enzyme Quality Target Product Profiles Manage projects with contract manufacturers for the production of GMP-grade nucleic acids and enzymes Represent viral vector and gene editing process development at CMC and cross-functional team meetings Contribute to experimental design and execution in the viral vector and gene editing process development lab Author technical reports, patents, peer-reviewed publications, and regulatory documents Basic Qualifications: Ph.D in Bioengineering, Biochemistry, Protein Engineering, or related discipline, or equivalent experience (8 - 10 years with B.S. or M.S.) Documented experience manufacturing gene editing raw materials for clinical and research applications Extensive knowledge and experience with CRISPR-Cas systems Effective communication including presentations to convey scientific concepts to research scientists, management teams, and external academic and industrial organizations Proven ability to work effectively as a member of a multidisciplinary team Strong organization, problem-solving, and project management skills with attention to detail Experience and working knowledge of concepts including but not limited to genetic engineering; nucleic acid and enzyme production, purification, and analytical methods; and gene therapy Preferred Qualifications: Previous work interfacing with contract manufacturing and development organizations Experience developing GMP manufacturing processes for globally-regulated products, such as vaccines, biologics, or cell & gene therapies Experience and working knowledge of viral vectors including AAV or lentiviral vectors About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene Seattle, WA, USA
Feb 19, 2020
Full time
Req #: Location: Seattle, Washington, United States Job Category: Technical Development Work Location: 400 Dexter Ave N. 98109 Organization: Bioengineering Employee Status: Full-time Job Type: Regular Scientist, Plasmid Production, Viral Vector and Gene Editing Process Development Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence, and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture. Celgene is developing clinical-stage, novel cellular immunotherapies based on two distinct and complementary platforms - Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body's immune system to treat cancer. Celgene is seeking an enthusiastic, self-driven individual to join the viral vector and gene editing process development team. The viral vector and gene editing team develops the processes and technology underpinning critical raw materials used in the manufacturing of engineered T cells. The primary focus of this Scientist will be to ensure successful GMP manufacturing of plasmid DNA used in viral vector production. This position will be responsible for providing technical subject matter expertise with internal and external development and manufacturing collaborators including supporting deviation closure, ensuring the processes meet qTPP and specifications, and contributing to comparability assessments due to any process changes. This Scientist will also contribute to wet lab experimental design and execution for viral vector production process development. Responsibilities: Support technology development and on-going activities with external collaborators and service providers (CMOs, CROs) Work with internal collaborators including supply chain, quality, and manufacturing sciences and technology to evaluate manufacturing proposals, technologies, and processes Manage projects with contract manufacturers for the production of GMP-grade plasmid DNA Represent viral vector and gene editing process development at CMC and cross-functional team meetings Contribute to experimental design and execution in the viral vector and gene editing process development lab Author technical reports, patents, peer-reviewed publications, and regulatory documents Basic Qualifications: B.S. with 10+ years, M.S. with 8+ years, or Ph.D. with 0-2 years of experience Documented experience manufacturing pDNA for clinical and research applications Extensive knowledge and experience with plasmid manufacturing systems Effective communication including presentations to convey scientific concepts to research scientists, management teams, and external academic and industrial organizations Proven ability to work effectively as a member of a multidisciplinary team Strong organization, problem-solving, and project management skills with attention to detail Experience and working knowledge of concepts including but not limited to genetic engineering, high-density E. coli fermentation, lysis techniques, chromatography, and plasmid analytical methods Preferred Qualifications: Previous work interfacing with contract manufacturing and development organizations Experience developing GMP manufacturing processes for globally-regulated products Experience and working knowledge of viral vectors including AAV or lentiviral vectors About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene Seattle, WA, USA
Feb 19, 2020
Full time
Req #: Location: Seattle, Washington, United States Job Category: Technical Development Work Location: 400 Dexter Ave N. 98109 Organization: Bioengineering Employee Status: Full-time Job Type: Regular Juno Therapeutics, a Celgene Company, is a clinical-stage company developing novel cellular immunotherapies based on two distinct and complementary platforms - Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body's immune system to treat cancer. We are looking for a Senior Scientist to lead the development of analytical methods of AAV vector in support of allogeneic CART programs. The ideal candidate has a proven track record of innovation, demonstrated skill set and knowledge in analytical development, and is excited to take on new challenges in a fast-paced and dynamic environment. This incumbent is responsible for overseeing development of AAV characterization and release assays at contract manufacturing organizations (CMOs) and contract test laboratories (CTLs) and coordinating the qualification and validation thereof. These analytical methods will be used to support QC release and in-process testing of AAV vector used for CART /TCR gene delivery. The incumbent will plan and coordinate execution of laboratory studies, analyze experimental data, document results, and present findings to CMC and Core teams. This position requires project leadership and management skills and attention to scientific detail. If you are dedicated to excellence and want to make a difference, we're excited to hear from you! Job Description: Coordinate development and qualification analytical methods to enable AAV process development, release and stability testing at CMOs/CTLs Lead the development of AAV control strategy; work with a cross-functional team to design and execute CMC development plan in support of allogeneic CART programs. Oversee the successful design, execution, interpretation, and documentation of experiments. Support AAV process development effort Contribute to development of novel technologies for gene and cell therapy. Author, review, and approve technical documents, including standard operating procedures, QC test methods, and analytical sampling plans. Contribution to regulatory submissions Summarize and present data in cross-functional team meetings Basic Qualifications: Ph.D. degree in virology, analytical sciences, or related field with 8+ years of experience in AAV analysis and/or drug development Knowledge and experience with AAV biology Demonstrated knowledge of control strategy and analytical development for CMC programs Demonstrated method development experience in techniques such as viral safety and potency assays, viral titer assays, quantitative PCR (qPCR), ELISA, etc. Demonstrated skillset in experimental design, data analysis, interpretation, and presentation. Proven ability to work in a fast-paced environment, meet deadlines, & prioritize work on multiple projects. Strong attention to detail with the ability to handle multiple responsibilities simultaneously Ability to work independently and as part of a team. Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment. Preferred Qualifications: Experience interfacing with contract manufacturing and research organizations, GMP contract test laboratories Demonstrated experience in cross-functional and functional leadership roles. Experience with gene engineering of T cells using viral modalities. Experience authoring technical and regulatory documents. Track record of successful internal and external scientific collaborations. About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene Berkeley Heights, NJ, USA
Feb 19, 2020
Full time
Req #: Location: Berkeley Heights, New Jersey, United States Job Category: Clinical Operations Work Location: 300 Connell Dr 07922 Organization: Biostatistics Employee Status: Full-time Job Type: Regular As our Principal Statistician you are responsible for providing statistical support to the study teams. Serves as primary biostatistician on multiple studies. Participates in the development of protocols and statistical analysis plans. Reviews CRFs, programming specifications, and data management plans. Performs statistical analysis, interprets statistical results, and participates in the preparation of clinical study reports. Oversees the work of CROs that are performing any of the above listed tasks. May travel up to 10%. Responsibilities and Duties: Participate in protocol development; Calculate sample sizes and/or perform power calculations for proposed studies as well as for alternative designs to evaluate the costs and timelines of various scenarios; Propose methods for statistical analysis and write the statistical sections of study protocols; Review and consult on CRF design and database edit checks; Review programming and analysis specifications; Prepare randomization schedules; Write statistical analysis plans and prepare table shells. Ensure that tables, listings, and figures address the objectives of the study; Perform statistical analyses of clinical data using SAS and other statistical software packages as necessary. Oversee the work of internal programmers and/or CROs that are performing statistical analyses of clinical data; Lead the study teams in the review, and discussion, of analysis plans; Interpret statistical results and present study findings to the teams, senior management, and in various external forums; Participate in organizing and writing results for primary publication; and Maintain project files that ensure adequate and clear documentation of statistical analyses. Other responsibilities as assigned. Quality Requirements: Play a key role in meeting cross-functional goals through commitment, quality standards, and a customer service orientation. Contribute to a work environment that fosters professionalism, mutual respect, teamwork, and collaboration. Knowledge, Skills, Abilities and Qualification Requirements: Master's degree or Ph.D. in statistics, biostatistics, mathematics, or related field; 8+ years of prior experience in a drug-development environment; Experience or training with a wide-range of skills including SAS programming and other relevant statistical software, statistical methodology and theories, and analysis; Excellent computer skills in the following programs: MS Word, PowerPoint, and Excel; Experience writing technical documents, reports, and presentations; Ability to manage multiple and diverse issues; Key Competencies: Professionalism and customer service orientation Communication skills - written and verbal Planning, organizing and multi-tasking Prioritizing and time management Problem assessment and problem solving Information gathering and information monitoring Attention to detail and accuracy Flexibility, adaptability and teamwork About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene Seattle, WA, USA
Feb 19, 2020
Full time
Req #: Location: Seattle, Washington, United States Job Category: Technical Development Work Location: 400 Dexter Ave N. 98109 Organization: Bioengineering Employee Status: Full-time Job Type: Regular The Potency Group is seeking a talented Scientist to lead projects that characterize the biological activity of autologous and allogenic cell therapies which are currently undergoing clinical trials, including CAR T cell products. The Scientist will lead a team of 1-3 individuals who are developing analytical methods that evaluate the biological activity ( e.g. metabolism, proliferation, and effector function) of novel cell therapies. The successful candidate will facilitate the identification of new functional characterization methods to develop and oversee the design, execution, and analyses of experiments that lead to the development of robust analytical methods. These methods will be used to further understanding of cell therapies, support development of the manufacturing processes, and/or QC release of the drug product. The successful candidate will have a strong background in Immunology or related field and will have experience in projects requiring close collaboration with other groups, such as discovery research, product sciences, process development, and QC. The Scientist will be passionate about developing novel medicines, thrive in an intellectually challenging environment, and enjoy collaborating with a team of likeminded Scientists. Qualifications and Education Requirements • PhD with 2-6 years of experience in the field of Immunology, Cancer Biology, or related field, preferably in an industry setting. • Expertise developing analytical methods that functional characterize T cells, such as their metabolism, proliferative capacity, and/or functional activity ( e.g. cytotoxicity, cytokine secretion, etc .) • Experience with cell culture, ELISAs or similar technology platforms ( e.g. MSD, Luminex, AlphaLISA, etc .), and flow cytometry. • Experienced with authoring and revising test methods, protocols, and technical reports. • Demonstrated experience leading teams and managing direct reports. Preferred Qualifications • Experience with fluorescence microscopy, live cell imaging and analysis ( i.e. IncuCyte), and/or image cytometry • Experience with molecular techniques, such as developing qPCR and next generation technologies such as NanoString, single cell RNA sequencing, and cellular indexing of transcriptomes and epitopes by sequencing (CITE-seq). • High dimensional data analysis ( e.g. CytoBank, viSNE, SPADE, CITRUS, etc .). • Experience with Design of Experiment (DoEs) using JMP or equivalent statistical software. • Proficiency with relative potency methods, 4-PL, robustness assessments, establishing system suitability criteria, critical reagent qualification procedures, analyst training, method transfers, and/or method qualification/validation. • Demonstrated experience qualifying, transferring, validating, performance trending, and/or lifecycle management of analytical methods. Specific Duties • Emphasis on hands-on leadership, mentorship of direct reports, and fostering a creative, collaborative, and accountable working environment. • Responsibility for the development of cell-based immunoassays and next-generation functional interrogation techniques. Proficiency with regulatory requirements, understanding of CMC strategy, awareness of industry trends, and advocate for new technologies. About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene Berkeley Heights, NJ, USA
Feb 19, 2020
Full time
Req #: Location: Berkeley Heights, New Jersey, United States Job Category: Clinical Operations Work Location: 300 Connell Dr 07922 Organization: Biostatistics Employee Status: Full-time Job Type: Regular Job Description: At Celgene Corporation, we're committed to changing the course of human health through bold pursuits in science, life-enhancing therapies and a promise to always put patients first. At the core of that mission are the talented individuals on our Biostatistics team who collaborate globally and cross-functionally to drive innovation. Join our team as a Director, Statistics - Real World Evidence and help us deliver truly innovative and life-changing medications to our patients worldwide. What great looks like in this Role: Our ideal Director, Statistics is responsible for leading initiating and overseeing statistical support for a growing area of Real-World Evidence trials in support of regulatory submissions and market access. If you're up for the challenge, apply today! Responsibilities of this Role: Requires managing multiple projects within Hematological Oncology and Solid Tumor Oncology indications Provides guidance and leadership in the appropriate design, management, analysis and reporting of RWE studies. Provide appropriate guidance to statisticians and programmers to ensure high quality and timely deliverables Manages resources, sets priorities, and ensures consistency and adherence to standards therein. Contributes to planning for submissions, and post-submission strategies, preparations and defenses. Contributes to creation/maintenance of, and provides training on statistical topics and departmental SOPs and WPs Seeks and responds to stakeholder feedback to increase efficiencies, synergies, and performance Represents Celgene at professional societies, and in industry-wide technical discussions. Is sought after as a trusted employee advocate and management coach by senior management regionally Resolves technical, quality, and timeline issues. Identifies external statistical experts for consultation Develops performance metrics for staff Provides guidance to employees' development plans and carries out performance review and feedback Manages a functional area and has authority to allocate company resources according to project needs Proactively builds partnerships with specialist functions and global counterparts to maximize knowledge and available resources Manages and coordinates limited resources to produce quality deliverables within timelines for competing priorities Ensures that flexible and rapid responses are provided for statistical requests Identifies and assists in the resolution of bottlenecks for study/project teams Participates in identifying strategies to optimize clinical trial design and in response to regulatory agencies' requests Represents the company in interfaces with regulatory agencies globally Serves as the statistical representative in the defense of the company position/approach on statistical issues and drug approvals globally Interacts and manages KOLs/CROs and represents the company in external scientific forums Develops and implements highly innovative solutions to solve complex corporate-wide problems Provides active coaching to biostatistical team members when developing solutions to problems. Manages team conflicts with external partners/customers Act as a resource/mentor to study team members - both internally and externally Shapes Biostatistics function to create and leverage programs, policies, and procedures to provide value added solutions for Biostatistics. Provides input into the long-term Biostatistics strategy and structure Assesses, provides direction, and resolves complex stakeholder concerns, providing direction to direct reports. Member of Management Staff. Provide Leadership Builds a professional and effective Statistical community that is seen as a business asset and attracts, develops and retains top talent Knowledge and Skills Required: Ph.D. in Statistics with 11+ years pharmaceutical experience in a pharmaceutical R&D environment OR MS in Statistics with 13+ years of related experience Strong knowledge of clinical trial design concepts, drug regulation, exploratory analyses for publication and experience in the management of the statistical function Knowledge of Real-World Evidence (RWE) methodology and experience with real world studies a decided advantage Excellent knowledge of SAS programming essential and knowledge of R a plus Demonstrated skill in the planning, analysis and reporting of clinical trials Detailed knowledge of statistical methodologies, particularly in propensity score modeling and other analyses of RWE Demonstrated ability to plan, organize, and prioritize multiple work assignments, and strong project management skills In-depth knowledge of all phases of the global drug development process Demonstrated ability to work in a team environment with clinical team members Good interpersonal, communication, writing and organizational skills Demonstrated skill in resource management Ability to research new statistical methods and ensure alignment with regulatory agencies and industry standards Demonstrated development of approaches to enhance the Workforce Planning and Talent Management strategy of the internal and external talent pools within a therapeutic area Demonstrated development of resourcing strategies and recruiting practices, working with senior leaders to define positions and organizational structure, and anticipating future requirements and specialty areas #LI-POST About Us At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies. About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene Seattle, WA, USA
Feb 14, 2020
Full time
Req #: Location: Seattle, Washington, United States Job Category: Technical Development Work Location: 400 Dexter Ave N. 98109 Organization: Bioengineering Employee Status: Full-time Job Type: Regular The Potency Group is seeking a talented Scientist to lead projects that characterize the biological activity of autologous and allogenic cell therapies which are currently undergoing clinical trials, including CAR T cell products. The Scientist will lead a team of 1-3 individuals who are developing analytical methods that evaluate the biological activity ( e.g. metabolism, proliferation, and effector function) of novel cell therapies. The successful candidate will facilitate the identification of new functional characterization methods to develop and oversee the design, execution, and analyses of experiments that lead to the development of robust analytical methods. These methods will be used to further understanding of cell therapies, support development of the manufacturing processes, and/or QC release of the drug product. The successful candidate will have a strong background in Immunology or related field and will have experience in projects requiring close collaboration with other groups, such as discovery research, product sciences, process development, and QC. The Scientist will be passionate about developing novel medicines, thrive in an intellectually challenging environment, and enjoy collaborating with a team of likeminded Scientists. Qualifications and Education Requirements • PhD with 2-6 years of experience in the field of Immunology, Cancer Biology, or related field, preferably in an industry setting. • Expertise developing analytical methods that functional characterize T cells, such as their metabolism, proliferative capacity, and/or functional activity ( e.g. cytotoxicity, cytokine secretion, etc .) • Experience with cell culture, ELISAs or similar technology platforms ( e.g. MSD, Luminex, AlphaLISA, etc .), and flow cytometry. • Experienced with authoring and revising test methods, protocols, and technical reports. • Demonstrated experience leading teams and managing direct reports. Preferred Qualifications • Experience with fluorescence microscopy, live cell imaging and analysis ( i.e. IncuCyte), and/or image cytometry • Experience with molecular techniques, such as developing qPCR and next generation technologies such as NanoString, single cell RNA sequencing, and cellular indexing of transcriptomes and epitopes by sequencing (CITE-seq). • High dimensional data analysis ( e.g. CytoBank, viSNE, SPADE, CITRUS, etc .). • Experience with Design of Experiment (DoEs) using JMP or equivalent statistical software. • Proficiency with relative potency methods, 4-PL, robustness assessments, establishing system suitability criteria, critical reagent qualification procedures, analyst training, method transfers, and/or method qualification/validation. • Demonstrated experience qualifying, transferring, validating, performance trending, and/or lifecycle management of analytical methods. Specific Duties • Emphasis on hands-on leadership, mentorship of direct reports, and fostering a creative, collaborative, and accountable working environment. • Responsibility for the development of cell-based immunoassays and next-generation functional interrogation techniques. Proficiency with regulatory requirements, understanding of CMC strategy, awareness of industry trends, and advocate for new technologies. About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene Seattle, WA, USA
Feb 10, 2020
Full time
Req #: Location: Seattle, Washington, United States Job Category: Technical Development Work Location: 400 Dexter Ave N. 98109 Organization: Bioengineering Employee Status: Full-time Job Type: Regular Juno Therapeutics, a Celgene Company, is a clinical-stage company developing novel cellular immunotherapies based on two distinct and complementary platforms - Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body's immune system to treat cancer. We are looking for a Senior Scientist to lead the development of analytical methods of AAV vector in support of allogeneic CART programs. The ideal candidate has a proven track record of innovation, demonstrated skill set and knowledge in analytical development, and is excited to take on new challenges in a fast-paced and dynamic environment. This incumbent is responsible for overseeing development of AAV characterization and release assays at contract manufacturing organizations (CMOs) and contract test laboratories (CTLs) and coordinating the qualification and validation thereof. These analytical methods will be used to support QC release and in-process testing of AAV vector used for CART /TCR gene delivery. The incumbent will plan and coordinate execution of laboratory studies, analyze experimental data, document results, and present findings to CMC and Core teams. This position requires project leadership and management skills and attention to scientific detail. If you are dedicated to excellence and want to make a difference, we're excited to hear from you! Job Description: Coordinate development and qualification analytical methods to enable AAV process development, release and stability testing at CMOs/CTLs Lead the development of AAV control strategy; work with a cross-functional team to design and execute CMC development plan in support of allogeneic CART programs. Oversee the successful design, execution, interpretation, and documentation of experiments. Support AAV process development effort Contribute to development of novel technologies for gene and cell therapy. Author, review, and approve technical documents, including standard operating procedures, QC test methods, and analytical sampling plans. Contribution to regulatory submissions Summarize and present data in cross-functional team meetings Basic Qualifications: Ph.D. degree in virology, analytical sciences, or related field with 8+ years of experience in AAV analysis and/or drug development Knowledge and experience with AAV biology Demonstrated knowledge of control strategy and analytical development for CMC programs Demonstrated method development experience in techniques such as viral safety and potency assays, viral titer assays, quantitative PCR (qPCR), ELISA, etc. Demonstrated skillset in experimental design, data analysis, interpretation, and presentation. Proven ability to work in a fast-paced environment, meet deadlines, & prioritize work on multiple projects. Strong attention to detail with the ability to handle multiple responsibilities simultaneously Ability to work independently and as part of a team. Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment. Preferred Qualifications: Experience interfacing with contract manufacturing and research organizations, GMP contract test laboratories Demonstrated experience in cross-functional and functional leadership roles. Experience with gene engineering of T cells using viral modalities. Experience authoring technical and regulatory documents. Track record of successful internal and external scientific collaborations. About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene Seattle, WA, USA
Feb 10, 2020
Full time
Req #: Location: Seattle, Washington, United States Job Category: Technical Development Work Location: 400 Dexter Ave N. 98109 Organization: Bioengineering Employee Status: Full-time Job Type: Regular Scientist, Plasmid Production, Viral Vector and Gene Editing Process Development Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence, and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture. Celgene is developing clinical-stage, novel cellular immunotherapies based on two distinct and complementary platforms - Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body's immune system to treat cancer. Celgene is seeking an enthusiastic, self-driven individual to join the viral vector and gene editing process development team. The viral vector and gene editing team develops the processes and technology underpinning critical raw materials used in the manufacturing of engineered T cells. The primary focus of this Scientist will be to ensure successful GMP manufacturing of plasmid DNA used in viral vector production. This position will be responsible for providing technical subject matter expertise with internal and external development and manufacturing collaborators including supporting deviation closure, ensuring the processes meet qTPP and specifications, and contributing to comparability assessments due to any process changes. This Scientist will also contribute to wet lab experimental design and execution for viral vector production process development. Responsibilities: Support technology development and on-going activities with external collaborators and service providers (CMOs, CROs) Work with internal collaborators including supply chain, quality, and manufacturing sciences and technology to evaluate manufacturing proposals, technologies, and processes Manage projects with contract manufacturers for the production of GMP-grade plasmid DNA Represent viral vector and gene editing process development at CMC and cross-functional team meetings Contribute to experimental design and execution in the viral vector and gene editing process development lab Author technical reports, patents, peer-reviewed publications, and regulatory documents Basic Qualifications: B.S. with 10+ years, M.S. with 8+ years, or Ph.D. with 0-2 years of experience Documented experience manufacturing pDNA for clinical and research applications Extensive knowledge and experience with plasmid manufacturing systems Effective communication including presentations to convey scientific concepts to research scientists, management teams, and external academic and industrial organizations Proven ability to work effectively as a member of a multidisciplinary team Strong organization, problem-solving, and project management skills with attention to detail Experience and working knowledge of concepts including but not limited to genetic engineering, high-density E. coli fermentation, lysis techniques, chromatography, and plasmid analytical methods Preferred Qualifications: Previous work interfacing with contract manufacturing and development organizations Experience developing GMP manufacturing processes for globally-regulated products Experience and working knowledge of viral vectors including AAV or lentiviral vectors About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene Seattle, WA, USA
Feb 10, 2020
Full time
Req #: Location: Seattle, Washington, United States Job Category: Technical Development Work Location: 400 Dexter Ave N. 98109 Organization: Bioengineering Employee Status: Full-time Job Type: Regular Scientist, Gene Editing Process Development Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence, and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture. Celgene is developing clinical-stage, novel cellular immunotherapies based on two distinct and complementary platforms - Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body's immune system to treat cancer. Celgene is seeking an enthusiastic, self-driven individual to join the viral vector and gene editing process development team. The viral vector and gene editing team develops the processes and technology underpinning critical raw materials used in the manufacturing of engineered T cells. The primary focus of this Scientist will be to ensure the development of GMP manufacturing for site-directed gene editing components including guide RNAs and enzymes. This position will be responsible for providing technical subject matter expertise with internal and external development and manufacturing collaborators including supporting deviation closure, ensuring the processes meet qTPP and specifications, and contributing to comparability assessments due to any process changes. This Scientist will also contribute to wet lab experimental design and execution for viral vector production process development. Responsibilities: Support technology development and on-going activities with external collaborators and service providers (CMOs, CROs) Work with internal collaborators to determine nucleic acid and enzyme Quality Target Product Profiles Manage projects with contract manufacturers for the production of GMP-grade nucleic acids and enzymes Represent viral vector and gene editing process development at CMC and cross-functional team meetings Contribute to experimental design and execution in the viral vector and gene editing process development lab Author technical reports, patents, peer-reviewed publications, and regulatory documents Basic Qualifications: Ph.D in Bioengineering, Biochemistry, Protein Engineering, or related discipline, or equivalent experience (8 - 10 years with B.S. or M.S.) Documented experience manufacturing gene editing raw materials for clinical and research applications Extensive knowledge and experience with CRISPR-Cas systems Effective communication including presentations to convey scientific concepts to research scientists, management teams, and external academic and industrial organizations Proven ability to work effectively as a member of a multidisciplinary team Strong organization, problem-solving, and project management skills with attention to detail Experience and working knowledge of concepts including but not limited to genetic engineering; nucleic acid and enzyme production, purification, and analytical methods; and gene therapy Preferred Qualifications: Previous work interfacing with contract manufacturing and development organizations Experience developing GMP manufacturing processes for globally-regulated products, such as vaccines, biologics, or cell & gene therapies Experience and working knowledge of viral vectors including AAV or lentiviral vectors About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene Berkeley Heights, NJ, USA
Feb 06, 2020
Full time
Req #: Location: Berkeley Heights, New Jersey, United States Job Category: Medical Work Location: 400 Connell Dr 07922 Organization: Medical Writing Employee Status: Full-time Job Type: Regular Principal Writer Medical Writing and Submission Planning DEPARTMENT Medical Writing and Submission Planning PREREQUISITES Minimum of BS/BA degree in science (Masters or PhD preferred) with approximately 5-10 years of regulatory writing and submission experience Responsibilities will include, but are not limited to, the following: 1. May act as medical writing lead on submission team or early development program. Author and give directions for preparing clinical and regulatory documents, including Investigator's Brochures, Clinical Study Reports (CTD Module 5), Integrated Summaries of Efficacy and Safety (CTD Module 5 for FDA), Clinical Summaries of Efficacy (CTD Section 2.7.3) and Safety (CTD Section 2.7.4), Clinical Overviews (CTD Section 2.5), Pediatric Investigation Plans, Proposed Pediatric Study Requests, Requests of Product Specific Waivers and Confirmation of the Applicability of Class Waivers, applications for Orphan Drug Designations, and responses to health authorities 2. May direct the entire document portfolio required for a project (eg, an NDA submission or an early development program) 3. Provide direction to team on content and optimal data presentation/summarization in the document 4. In collaboration with medical writing and other functions, prepare internal guidelines for document preparation and templates for clinical documents that are consistent with EMA, FDA and ICH guidelines, and with electronic submission guidelines 5. Develop the strategy for document preparation and the document review processes, including the management of timelines 6. Facilitate document review meetings and discussions 7. May contribute to Clinical Trial Data Sharing activities, including act as the lead for team review and redaction of private patient and/or confidential commercial information from documents, manage data sharing projects and vendors 8. Participate in planning for medical writing resources and contribute to the development of project timelines 9. Manage teams and medical writing projects 10. Review work of other writers for accuracy, quality, focus, and adherence to format and stylistic requirements 11. Serve as mentor for medical writers and senior medical writers Skills/Knowledge Required: • Experience writing clinical and regulatory documents • Experience with registration dossiers for worldwide use preferred • Understanding of drug development processes • Knowledgeable in preclinical development including discovery, toxicology etc • Knowledge of EMA, FDA and ICH guidelines • Ability to work with complex projects and within cross-functional teams • Experience with effectively managing vendors and contract writers to meet timelines/project objectives preferred • Expertise in multiple therapeutic areas • Excellent grammatical and communication skills, both written and oral • Expertise in MS WORD, including the ability to solve technical problems with WORD templates • Previous leadership or supervisory/mentoring experience preferred About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene Berkeley Heights, NJ, USA
Feb 05, 2020
Full time
Req #: Location: Berkeley Heights, New Jersey, United States Job Category: Information Technology Work Location: 300 Connell Dr 07922 Organization: Clinical Programming Employee Status: Full-time Job Type: Regular Job Description Responsibilities will include, but are not limited to, the following: Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells. Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs. Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results. Ensure consistency and adherence to standards within their therapeutic area. Provide input to the design of the clinical trial database for proper data capture and to ensure data quality. Create Data Definition Tables (DDT) and converting TFLs to the required format for eSubmission. Convert, verify and integrate multiple sources of incoming data for the creation of analysis datasets. Provide programming support for the preparation of integrated reports, submissions and post-submission activities. Serve as the lead programmer in support of NDAs, sNDAs. Contribute to the creation, maintenance, and validation of standards for programming tools, outputs and macros. Provide training on departmental SOPs/WPs and standard programs. Contribute to the creation of naming conventions and standards for the programming environment. Routinely interface with cross-functional team members. Influences other functions and represents as DOP technical expertise. Represent as internal team leader who decides best course of action. Coach and advise junior programmers to identify problems and solutions. Oversee the services provided by CROs. Skills/Knowledge Required: Bachelor's degree in life science, statistics, mathematics, computer science, or related field is required; Master's degree is preferred. 9 plus years Pharmaceutical/CRO experience as a SAS Programmer supporting clinical trials for regulatory submissions with a Bachelor's degree; or 8 plus years experience with a MS/MA degree. Demonstrated proficiency in using SAS to produce derived analysis datasets and produce TFLs. Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats. Demonstrated skills in using additional software tools and applications (e.g. MS office, XML). Demonstrated expertise in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM. Demonstrated expertise in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission. In-depth understanding of regulatory, industry, and technology standards and requirements. Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs. Demonstrated ability to work in a team environment with clinical team members. Excellent planning and project management skills. Good interpersonal, communication, writing and organizational skills. Keep abreast of evolving regulatory, industry, and technology changes and demands, e.g., CDISC, SDTM, ADaM, eDC. #LI-POST About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene Berkeley Heights, NJ, USA
Feb 05, 2020
Full time
Req #: Location: Berkeley Heights, New Jersey, United States Job Category: Clinical Operations Work Location: 300 Connell Dr 07922 Organization: Biostatistics Employee Status: Full-time Job Type: Regular Job Description: At Celgene Corporation, we're committed to changing the course of human health through bold pursuits in science, life-enhancing therapies and a promise to always put patients first. At the core of that mission are the talented individuals on our Biostatistics team who collaborate globally and cross-functionally to drive innovation. Join our team as a Director, Statistics - Real World Evidence and help us deliver truly innovative and life-changing medications to our patients worldwide. What great looks like in this Role: Our ideal Director, Statistics is responsible for leading initiating and overseeing statistical support for a growing area of Real-World Evidence trials in support of regulatory submissions and market access. If you're up for the challenge, apply today! Responsibilities of this Role: Requires managing multiple projects within Hematological Oncology and Solid Tumor Oncology indications Provides guidance and leadership in the appropriate design, management, analysis and reporting of RWE studies. Provide appropriate guidance to statisticians and programmers to ensure high quality and timely deliverables Manages resources, sets priorities, and ensures consistency and adherence to standards therein. Contributes to planning for submissions, and post-submission strategies, preparations and defenses. Contributes to creation/maintenance of, and provides training on statistical topics and departmental SOPs and WPs Seeks and responds to stakeholder feedback to increase efficiencies, synergies, and performance Represents Celgene at professional societies, and in industry-wide technical discussions. Is sought after as a trusted employee advocate and management coach by senior management regionally Resolves technical, quality, and timeline issues. Identifies external statistical experts for consultation Develops performance metrics for staff Provides guidance to employees' development plans and carries out performance review and feedback Manages a functional area and has authority to allocate company resources according to project needs Proactively builds partnerships with specialist functions and global counterparts to maximize knowledge and available resources Manages and coordinates limited resources to produce quality deliverables within timelines for competing priorities Ensures that flexible and rapid responses are provided for statistical requests Identifies and assists in the resolution of bottlenecks for study/project teams Participates in identifying strategies to optimize clinical trial design and in response to regulatory agencies' requests Represents the company in interfaces with regulatory agencies globally Serves as the statistical representative in the defense of the company position/approach on statistical issues and drug approvals globally Interacts and manages KOLs/CROs and represents the company in external scientific forums Develops and implements highly innovative solutions to solve complex corporate-wide problems Provides active coaching to biostatistical team members when developing solutions to problems. Manages team conflicts with external partners/customers Act as a resource/mentor to study team members - both internally and externally Shapes Biostatistics function to create and leverage programs, policies, and procedures to provide value added solutions for Biostatistics. Provides input into the long-term Biostatistics strategy and structure Assesses, provides direction, and resolves complex stakeholder concerns, providing direction to direct reports. Member of Management Staff. Provide Leadership Builds a professional and effective Statistical community that is seen as a business asset and attracts, develops and retains top talent Knowledge and Skills Required: Ph.D. in Statistics with 11+ years pharmaceutical experience in a pharmaceutical R&D environment OR MS in Statistics with 13+ years of related experience Strong knowledge of clinical trial design concepts, drug regulation, exploratory analyses for publication and experience in the management of the statistical function Knowledge of Real-World Evidence (RWE) methodology and experience with real world studies a decided advantage Excellent knowledge of SAS programming essential and knowledge of R a plus Demonstrated skill in the planning, analysis and reporting of clinical trials Detailed knowledge of statistical methodologies, particularly in propensity score modeling and other analyses of RWE Demonstrated ability to plan, organize, and prioritize multiple work assignments, and strong project management skills In-depth knowledge of all phases of the global drug development process Demonstrated ability to work in a team environment with clinical team members Good interpersonal, communication, writing and organizational skills Demonstrated skill in resource management Ability to research new statistical methods and ensure alignment with regulatory agencies and industry standards Demonstrated development of approaches to enhance the Workforce Planning and Talent Management strategy of the internal and external talent pools within a therapeutic area Demonstrated development of resourcing strategies and recruiting practices, working with senior leaders to define positions and organizational structure, and anticipating future requirements and specialty areas #LI-POST About Us At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies. About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene Berkeley Heights, NJ, USA
Feb 05, 2020
Full time
Req #: Location: Berkeley Heights, New Jersey, United States Job Category: Clinical Operations Work Location: 300 Connell Dr 07922 Organization: Biostatistics Employee Status: Full-time Job Type: Regular Responsibilities will include, but are not limited to, the following: Contribute to efficient study design, preparing statistical consideration sections and providing input into other protocol sections. Perform simulations for ED statistical innovative designs. Prepare statistical analysis plans including table shells. Analyze clinical trial data; work with programmers to provide tables, listings and graphs, including ad hoc validation. Maintain / upgrade home-grown ED Stats software with ED Bayesian Methods. Review, synthesize, interpret and report analysis results. Provide ad hoc data driven analyses. Provide statistical input for the preparation of final study reports and other required documents. Escalates issues to functional management as necessary. Makes recommendations or resolves technical, quality, and timeline issues. Skills/Knowledge Required: MS or Ph.D in Statistics. At least 2 years clinical drug development experience with a Master's degree; or no additional experience with a Ph.D. as a study statistician. 1 plus years statistical computing experience (e.g. SAS, R, or other statistical computing software) Knowledge of MS Office products (Word, Excel, PowerPoint) Demonstrated skill in statistical methodologies and data analysis, especially in Bayesian methods. Knowledge of clinical trial design concepts. Also knowledge of Bayesian innovative designs in ED Demonstrated ability to learn statistical regulatory requirements. Good interpersonal, communication, writing and organizational skills. Ability to work in a team environment with medical personnel, clinical monitors, data managers, programmers and medical writers. About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene Berkeley Heights, NJ, USA
Feb 05, 2020
Full time
Req #: Location: Berkeley Heights, New Jersey, United States Job Category: Clinical Operations Work Location: 300 Connell Dr 07922 Organization: Biostatistics Employee Status: Full-time Job Type: Regular As our Principal Statistician you are responsible for providing statistical support to the study teams. Serves as primary biostatistician on multiple studies. Participates in the development of protocols and statistical analysis plans. Reviews CRFs, programming specifications, and data management plans. Performs statistical analysis, interprets statistical results, and participates in the preparation of clinical study reports. Oversees the work of CROs that are performing any of the above listed tasks. May travel up to 10%. Responsibilities and Duties: Participate in protocol development; Calculate sample sizes and/or perform power calculations for proposed studies as well as for alternative designs to evaluate the costs and timelines of various scenarios; Propose methods for statistical analysis and write the statistical sections of study protocols; Review and consult on CRF design and database edit checks; Review programming and analysis specifications; Prepare randomization schedules; Write statistical analysis plans and prepare table shells. Ensure that tables, listings, and figures address the objectives of the study; Perform statistical analyses of clinical data using SAS and other statistical software packages as necessary. Oversee the work of internal programmers and/or CROs that are performing statistical analyses of clinical data; Lead the study teams in the review, and discussion, of analysis plans; Interpret statistical results and present study findings to the teams, senior management, and in various external forums; Participate in organizing and writing results for primary publication; and Maintain project files that ensure adequate and clear documentation of statistical analyses. Other responsibilities as assigned. Quality Requirements: Play a key role in meeting cross-functional goals through commitment, quality standards, and a customer service orientation. Contribute to a work environment that fosters professionalism, mutual respect, teamwork, and collaboration. Knowledge, Skills, Abilities and Qualification Requirements: Master's degree or Ph.D. in statistics, biostatistics, mathematics, or related field; 8+ years of prior experience in a drug-development environment; Experience or training with a wide-range of skills including SAS programming and other relevant statistical software, statistical methodology and theories, and analysis; Excellent computer skills in the following programs: MS Word, PowerPoint, and Excel; Experience writing technical documents, reports, and presentations; Ability to manage multiple and diverse issues; Key Competencies: Professionalism and customer service orientation Communication skills - written and verbal Planning, organizing and multi-tasking Prioritizing and time management Problem assessment and problem solving Information gathering and information monitoring Attention to detail and accuracy Flexibility, adaptability and teamwork About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene Seattle, WA, USA
Feb 05, 2020
Full time
Req #: Location: Seattle, Washington, United States Job Category: Clinical Operations Work Location: 400 Dexter Ave N. 98109 Organization: Biostatistics Employee Status: Full-time Job Type: Regular As our Principal Statistician (Cell Therapy CMC) you are responsible for providing statistical support to the Cell Therapy CMC teams. Serves as primary Biostatistician on multiple analytical and manufacturing process related activities. Participates in the development of protocols and statistical analysis plans. Performs statistical analysis, interprets statistical results, and participates in the preparation of study reports. Oversees the work of others that are performing any of the above listed tasks. May travel up to 10%. Responsibilities and Duties: Participate in protocol development; Calculate sample sizes and/or perform power calculations for proposed studies as well as for alternative designs to evaluate the costs and timelines of various scenarios; Propose methods for statistical analysis and write the statistical sections of study protocols; Experience with the statistical aspects of Analytical method development, qualification, validation, transfer, comparability and troubleshooting. Experience with the statistical aspects of Process development, characterization, comparability, PPQ and troubleshooting. Experience with the statistical aspects of translational development, stability analysis & shelf life determination and specification setting. Review programming and analysis specifications; Write statistical analysis plans; Perform statistical analyses of CMC data using JMP / SAS and other statistical software packages as necessary. Oversee the work of scientists / engineers that are performing statistical analyses of CMC data; Lead the study teams in the review, and discussion, of analysis plans; Interpret statistical results and present study findings to the teams, senior management, and in various external forums; Participate in organizing and writing results for primary publication; and Maintain project files that ensure adequate and clear documentation of statistical analyses. Other responsibilities as assigned. Quality Requirements: Play a key role in meeting cross-functional goals through commitment, quality standards, and a customer service orientation. Contribute to a work environment that fosters professionalism, mutual respect, teamwork, and collaboration. Knowledge, Skills, Abilities and Qualification Requirements: Master's degree or Ph.D. in statistics,Biostatistics, mathematics, or related field; 8+ years of prior experience in a CMC drug-development environment; Experience or training with a wide-range of skills including JMP/ SAS programming and other relevant statistical software such as Minitab and / or R, statistical methodology and theories, and analysis; Excellent computer skills in the following programs: MS Word, PowerPoint, and Excel; Experience writing technical documents, reports, and presentations; Ability to manage multiple and diverse issues; Key Competencies: Professionalism and customer service orientation Communication skills - written and verbal Planning, organizing and multi-tasking Prioritizing and time management Problem assessment and problem solving Information gathering and information monitoring Attention to detail and accuracy Flexibility, adaptability and teamwork About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.