AbbVie

  • South San Francisco (Pharmacyclics) 601 Gateway Blvd, Suite 100 South San Francisco, California 94080
  • https://www.abbvie.com
AbbVie San Diego, CA, USA
Nov 16, 2019
Full time
This individual will be responsible for developing and maintaining strategic business relationships with Oncology departments and practices consisting of interactions with Oncologists, Hematologists, nurses, executive level personnel, marketing, department managers, Healthcare Providers and various other physicians and support staff. Business relationships will be focused on increasing education on product benefits/risks consistent with approved label, developing new business, improving resource utilization, and growing sales and market share by achieving sales plan for the assigned Oncology product portfolio. Learn more about this role and what it takes and what we are looking for as an Account Executive within Oncology! Key Responsibilities Include: Uses opportunities to understand and address customer needs! Builds strong relationships that provide market intelligence and support development of compliant and innovative programs and initiatives. Builds and maintains relationships across accounts that result in opportunities to benefit patients, physicians, and other HCPs within the geography. Consistently partners with in-house and/or cross-franchise leaders, and collaborates with such partners to identify, design and/or adapt appropriate approaches and tactics demonstrating resources within geography. Delivers effective on-label technical and scientific presentations utilizing approved data, to include supporting data, to appropriately highlight the benefits and risks of the product resulting in sales quota achievement. Serve as lead US Commercial contact with targeted accounts in assigned geography and collaborate with all AbbVie and any co-promotion Counterparts including Marketing, Managed Care, Hematology Clinical Coordinators, Thought Leader Liaisons, and contracted SPPs to provide excellent customer support for physicians to the benefit of their patients. Such support should include site support and addressing any potential customer issues. Build, implement and communicate strategic and tactical plans for targeted accounts. In collaboration with sales leadership and other appropriate AbbVie or Co-Promote partners, facilitate site physician/treatment team training on approved and safe use of AbbVie's products. Monitor and report sales progress. Provide routine communications to all internal and external (as applicable) partners. Act as AbbVie key point of contact to each account. Respond to or direct customer to the appropriate service or point of contact for their questions or requests and actively follow-up. Take lead in coordinating and ensuring any needed or requested support is delivered in a timely manner and to the satisfaction of the account. Attend and actively participate in local clinician boards, societies, meetings and the like. Represent AbbVie and assigned products at such venues, build/improve new/existing relationships. Channel key information, developments or findings to internal partners/stakeholders. All communications in these forums are on-label. Remain current on all clinical, market, and payer developments, tends, and issues specific to oncology. Complete all AbbVie required training and maintain adherence to all company policies and OEC/Legal procedures. Within assigned accounts and geography, seeks out important information and articulates implications to our business and to our customers' business'. Transfers knowledge to appropriate internal partners and integrates standard methodologies that have tangible value for customers and patients across assigned brands to benefit the geography. Establishes and maintains a complete understanding of approved product label and disease state knowledge for impactful use with customers. Optimizes both external and internal data, resources, and tools to identify sales opportunities and program strategy for customers in assigned territories. With the approval of legal/OEC, actively participates in relevant organizational programs in local markets. Develops a strong command of available selling resources and tools; fully demonstrates those resources to support selling strategies and maximize impact. Provide all physician detailing using AbbVie approved materials and in accordance with all of AbbVie's policies and procedures. An essential requirement of your position is to meet health care industry representative (HCIR) credentialing requirements to gain entry into facilities and organizations that are in your assigned territory. These HCIR credentialing requirements may include, but are not limited to, background checks, drug screens, and proof of immunization/vaccination for various diseases. Basic: Bachelor's degree 3+ years Oncology or Specialty Pharmaceutical Sales/Account Executive experience. Knowledge of applicable regulations and standards affecting Pharmaceutical Products Strong eye for business; analytical ability to analyze diverse sets of data using multiple tools and define account/program strategies that drive business objectives. Must demonstrate an understanding of how to effectively meet customer needs in a complex environment through forward-thinking, innovative strategies that align with the company and customer objectives. Effectively demonstrate leadership skills; ability to lead without direct authority. Has experience with successfully developing teams on complex projects or challenges to achieve results. Excellent communication and presentation skills. Preferred: MBA 5+ years Oncology or Specialty Pharmaceutical Sales/Account Executive experience. Experience operating in a Specialty Pharmacy Provider environment. Oncology and/or account management experience. People management or other leadership experience
AbbVie Manhattan, New York, NY, USA
Nov 16, 2019
Full time
This individual will be responsible for developing and maintaining strategic business relationships with Oncology departments and practices consisting of interactions with Oncologists, Hematologists, nurses, executive level personnel, marketing, department managers, Healthcare Providers and various other physicians and support staff. Business relationships will be focused on increasing education on product benefits/risks consistent with approved label, developing new business, improving resource utilization, and growing sales and market share by achieving sales plan for the assigned Oncology product portfolio. Learn more about this role and what it takes and what we are looking for as an Account Executive within Oncology! Key Responsibilities Include: Uses opportunities to understand and address customer needs! Builds strong relationships that provide market intelligence and support development of compliant and innovative programs and initiatives. Builds and maintains relationships across accounts that result in opportunities to benefit patients, physicians, and other HCPs within the geography. Consistently partners with in-house and/or cross-franchise leaders, and collaborates with such partners to identify, design and/or adapt appropriate approaches and tactics demonstrating resources within geography. Delivers effective on-label technical and scientific presentations utilizing approved data, to include supporting data, to appropriately highlight the benefits and risks of the product resulting in sales quota achievement. Serve as lead US Commercial contact with targeted accounts in assigned geography and collaborate with all AbbVie and any co-promotion Counterparts including Marketing, Managed Care, Hematology Clinical Coordinators, Thought Leader Liaisons, and contracted SPPs to provide excellent customer support for physicians to the benefit of their patients. Such support should include site support and addressing any potential customer issues. Build, implement and communicate strategic and tactical plans for targeted accounts. In collaboration with sales leadership and other appropriate AbbVie or Co-Promote partners, facilitate site physician/treatment team training on approved and safe use of AbbVie's products. Monitor and report sales progress. Provide routine communications to all internal and external (as applicable) partners. Act as AbbVie key point of contact to each account. Respond to or direct customer to the appropriate service or point of contact for their questions or requests and actively follow-up. Take lead in coordinating and ensuring any needed or requested support is delivered in a timely manner and to the satisfaction of the account. Attend and actively participate in local clinician boards, societies, meetings and the like. Represent AbbVie and assigned products at such venues, build/improve new/existing relationships. Channel key information, developments or findings to internal partners/stakeholders. All communications in these forums are on-label. Remain current on all clinical, market, and payer developments, tends, and issues specific to oncology. Complete all AbbVie required training and maintain adherence to all company policies and OEC/Legal procedures. Within assigned accounts and geography, seeks out important information and articulates implications to our business and to our customers' business'. Transfers knowledge to appropriate internal partners and integrates standard methodologies that have tangible value for customers and patients across assigned brands to benefit the geography. Establishes and maintains a complete understanding of approved product label and disease state knowledge for impactful use with customers. Optimizes both external and internal data, resources, and tools to identify sales opportunities and program strategy for customers in assigned territories. With the approval of legal/OEC, actively participates in relevant organizational programs in local markets. Develops a strong command of available selling resources and tools; fully demonstrates those resources to support selling strategies and maximize impact. Provide all physician detailing using AbbVie approved materials and in accordance with all of AbbVie's policies and procedures. An essential requirement of your position is to meet health care industry representative (HCIR) credentialing requirements to gain entry into facilities and organizations that are in your assigned territory. These HCIR credentialing requirements may include, but are not limited to, background checks, drug screens, and proof of immunization/vaccination for various diseases. Basic: Bachelor's degree 3+ years Oncology or Specialty Pharmaceutical Sales/Account Executive experience. Knowledge of applicable regulations and standards affecting Pharmaceutical Products Strong eye for business; analytical ability to analyze diverse sets of data using multiple tools and define account/program strategies that drive business objectives. Must demonstrate an understanding of how to effectively meet customer needs in a complex environment through forward-thinking, innovative strategies that align with the company and customer objectives. Effectively demonstrate leadership skills; ability to lead without direct authority. Has experience with successfully developing teams on complex projects or challenges to achieve results. Excellent communication and presentation skills. Preferred: MBA 5+ years Oncology or Specialty Pharmaceutical Sales/Account Executive experience. Experience operating in a Specialty Pharmacy Provider environment. Oncology and/or account management experience. People management or other leadership experience
AbbVie Houston, TX, USA
Nov 16, 2019
Full time
This individual will be responsible for developing and maintaining strategic business relationships with Oncology departments and practices consisting of interactions with Oncologists, Hematologists, nurses, executive level personnel, marketing, department managers, Healthcare Providers and various other physicians and support staff. Business relationships will be focused on increasing education on product benefits/risks consistent with approved label, developing new business, improving resource utilization, and growing sales and market share by achieving sales plan for the assigned Oncology product portfolio. Learn more about this role and what it takes and what we are looking for as an Account Executive within Oncology! Key Responsibilities Include: Uses opportunities to understand and address customer needs! Builds strong relationships that provide market intelligence and support development of compliant and innovative programs and initiatives. Builds and maintains relationships across accounts that result in opportunities to benefit patients, physicians, and other HCPs within the geography. Consistently partners with in-house and/or cross-franchise leaders, and collaborates with such partners to identify, design and/or adapt appropriate approaches and tactics demonstrating resources within geography. Delivers effective on-label technical and scientific presentations utilizing approved data, to include supporting data, to appropriately highlight the benefits and risks of the product resulting in sales quota achievement. Serve as lead US Commercial contact with targeted accounts in assigned geography and collaborate with all AbbVie and any co-promotion Counterparts including Marketing, Managed Care, Hematology Clinical Coordinators, Thought Leader Liaisons, and contracted SPPs to provide excellent customer support for physicians to the benefit of their patients. Such support should include site support and addressing any potential customer issues. Build, implement and communicate strategic and tactical plans for targeted accounts. In collaboration with sales leadership and other appropriate AbbVie or Co-Promote partners, facilitate site physician/treatment team training on approved and safe use of AbbVie's products. Monitor and report sales progress. Provide routine communications to all internal and external (as applicable) partners. Act as AbbVie key point of contact to each account. Respond to or direct customer to the appropriate service or point of contact for their questions or requests and actively follow-up. Take lead in coordinating and ensuring any needed or requested support is delivered in a timely manner and to the satisfaction of the account. Attend and actively participate in local clinician boards, societies, meetings and the like. Represent AbbVie and assigned products at such venues, build/improve new/existing relationships. Channel key information, developments or findings to internal partners/stakeholders. All communications in these forums are on-label. Remain current on all clinical, market, and payer developments, tends, and issues specific to oncology. Complete all AbbVie required training and maintain adherence to all company policies and OEC/Legal procedures. Within assigned accounts and geography, seeks out important information and articulates implications to our business and to our customers' business'. Transfers knowledge to appropriate internal partners and integrates standard methodologies that have tangible value for customers and patients across assigned brands to benefit the geography. Establishes and maintains a complete understanding of approved product label and disease state knowledge for impactful use with customers. Optimizes both external and internal data, resources, and tools to identify sales opportunities and program strategy for customers in assigned territories. With the approval of legal/OEC, actively participates in relevant organizational programs in local markets. Develops a strong command of available selling resources and tools; fully demonstrates those resources to support selling strategies and maximize impact. Provide all physician detailing using AbbVie approved materials and in accordance with all of AbbVie's policies and procedures. An essential requirement of your position is to meet health care industry representative (HCIR) credentialing requirements to gain entry into facilities and organizations that are in your assigned territory. These HCIR credentialing requirements may include, but are not limited to, background checks, drug screens, and proof of immunization/vaccination for various diseases. Basic: Bachelor's degree 3+ years Oncology or Specialty Pharmaceutical Sales/Account Executive experience. Knowledge of applicable regulations and standards affecting Pharmaceutical Products Strong eye for business; analytical ability to analyze diverse sets of data using multiple tools and define account/program strategies that drive business objectives. Must demonstrate an understanding of how to effectively meet customer needs in a complex environment through forward-thinking, innovative strategies that align with the company and customer objectives. Effectively demonstrate leadership skills; ability to lead without direct authority. Has experience with successfully developing teams on complex projects or challenges to achieve results. Excellent communication and presentation skills. Preferred: MBA 5+ years Oncology or Specialty Pharmaceutical Sales/Account Executive experience. Experience operating in a Specialty Pharmacy Provider environment. Oncology and/or account management experience. People management or other leadership experience
AbbVie Illinois, USA
Nov 16, 2019
Full time
The Marketing Manager for RINVOQ (upadacitinib) will be responsible for numerous executional elements as the brand prepares for launching additional indications in spondylarthritis (SpA) - psoriatic arthritis (PsA) and ankylosing spondylitis (AS). The MM will coordinate across both internal and external stakeholders to enable an integrated and successful launch. Strategic elements of the role will include everything from deep understanding of customer insights through engagement strategies to closed-loop marketing. Key elements this person will be responsible for include leading the development and execution of the Professional tactics to drive brand and disease awareness through a variety of channels including, but not limited to, website, in-office, digital communications. Partnering with other MMs across the Immunology franchise, both US and International, will be critical to ensure successful implementation of tactics for RINVOQ SpA. Job Description - The responsibilities of this role are listed below but may shift based on launch needs. Launch Preparation - This individual will support the launch planning for RINVOQ SpA, including the synthesis of market research insights and complex clinical data that informs innovative tactical execution. Brand Identity and Campaign Development - This individual will contribute to the visual identity of the brand and work to develop and execute a creative campaign that is insights-driven. Execution of Professional Tactics - This person will execute, in partnership with the agency and MRL partners, key Professional tactics to support the launch of RINVOQ SpA. 360 Degree Promotion - This individual will develop a strategy to create a closed-loop marketing environment around Professional customers that includes all channels including the salesforce. This person will execute key tactics in partnership with the agency and MRL partners. Sales Force Engagement - This individual will partner closely with the sales force and sales training to develop comprehensive and effective tools that will allow for a strong launch. Strategic Communication - This individual will plan and execute an internal and external communication plan in partnership with Medical, Public Affairs, and other cross-functional partners to maximize share-of-voice of RINVOQ SpA. Finance - This individual will ensure RINVOQ SpA stays within budget and partners with finance and other brand partners to maintain oversight throughout the year. This individual will report to the Marketing Director, RINVOQ SpA. Basic: Bachelor's degree in marketing or related field Proven ability to complete work product on-time with excellence Proven ability to work cross-functionally Pharmaceutical marketing experience Excellent communication (oral, written, and presentation) and interpersonal skills Strong planning and organization skills, attention to detail, execution, and follow-through Budget management experience Preferred: 3+ years of relevant brand marketing experience Prior experience in Professional pharmaceutical marketing Pharmaceutical launch experience Strategic and tactical planning experience MBA or other advanced degree
AbbVie Omaha, NE, USA
Nov 16, 2019
Full time
Purpose : Perform all aspects of account management, including developing and maintaining strategic business relationships with corporate/senior management staff in key accounts with the goal of establishing multi-level relationships to increase representative access, develop new business, improve resource utilization, and increase sales and market share of the assigned product. Responsibilities : Work with internal teams to manage and identify key target account opportunities. Develop product strategies to fully and consistently penetrate these accounts. Delete Provide strategic and tactical direction regarding target accounts to regional and district teams. Advise sales and marketing management with appropriate direction on challenges and opportunities within key target accounts. Analyze and supports channel specific training needs within the Region. Delete Develop an annual business plan with goals and objectives to increase sales volume and market share in target accounts across all FDA approved indications. Routinely identify local opportunities and threats and develop/modify business plans accordingly. Anticipate change and take proactive measures to address. Understand and effectively utilize a broad range of financial and quantitative data and analyses. Assess business impact of target account opportunities to include overall profitability and impact on sales. Delete Partner with Field Sales Managers to evaluate and penetrate non-retail account drivers within MSAs. Delete Drive target account volume and share growth through detailed analysis, providing recommendations and driving execution and pull through of District Managers and representatives. Bachelor's Degree required. At least 2 years sales or account management experience. Demonstrated ability to network and partner effectively across functional areas. Excellent organizational/project management and demonstrated leadership skills. Consistent record of managing multiple stakeholders in complex environments. Preferred: Immunology experience and experience in large health systems.
AbbVie Seattle, WA, USA
Nov 16, 2019
Full time
Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes. Overviews the overall activities of site personnel over whom there is no direct authority and motivates/influences them to meet study objectives. proactively manages the site and ensures action plans are put into place as needed to ensure compliance. Ensures regulatory inspection readiness at assigned clinical sites. Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. Ensures safety and protection of study subjects through compliance with the study monitoring plan, AbbVie SOPs, ICH Guidelines, and applicable regulations. Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members. Manages investigator payments as per executed contract obligations. Negotiates investigator/ hospital agreements with stakeholders. Maintain and complete own expense reports as per local and applicable guidelines. Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators. High School Diploma, GED or OUS equivalent required. Bachelor's or equivalent health related (e.g., Medical, Scientific, Nursing) degree preferred. Minimum of 1 year of clinically-related experience, of which a period of 6 months is preferable in clinical research monitoring. Experience in on-site monitoring of investigational drug or device trials is required Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials. Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations. Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. Ability to work, understand and follow work processes within the assigned function. Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity. Ability to address study related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated. Ability to use functional expertise and exercise good judgment. Demonstrated business ethics and integrity.
AbbVie Sunnyvale, CA, USA
Nov 16, 2019
Full time
Primary Job Function : Conceive and execute novel scientific research or development that achieves projects and area goals. Expertise in synthetic organic chemistry is an essential requirement of this position to drive the SAR optimization cycle to achieve project goals. Expected to generate new synthetic and medicinal chemistry proposals and lead those efforts. Generate new scientific proposals and lead those efforts. Investigate, identify, develop, and optimize new methods and techniques. Act as a lead scientist in his/her area of expertise and critically evaluate relevant scientific and regulatory advances and integrate this knowledge into research or development programs. Core Job Responsibilities : Maintain a high level of productivity in the laboratory setting by generating high impact compounds. Demonstrate the ability to resolve key project hurdles and assumptions by effectively utilizing available information and technical expertise. Seize opportunities to pursue project relevant leads that are in line with the group's strategy, and be responsible for developing new SAR/series. Proactively seek out new information in the literature and incorporate into individual project(s) as well as the overall program. Publish research in peer-reviewed journals and present work at scientific conferences. Effective writer and communicator of research or other regulatory materials. Position Accountability/Scope : Demonstrate a high degree of responsibility in maintaining scientific standards, and safe laboratory practices. Participate in establishing project goals, defining short and long-term scientific strategies, and contribute to the generation of project-related documents and presentations. Keep accurate and current records of research and/or project related activities according to AbbVie policies. Internal/External Contacts and Interactions : Use external information to gain competitive intelligence. Act as advocate to integrate this knowledge into the group's research efforts. Generate new research or development strategies to effectively address project and divisional goals/needs. Collaborate with functional and technical experts to facilitate scientific achievement. Publish project-related research in high-impact factor peer-reviewed journals, R&D reports, patent applications and/or regulatory documents/filings. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. PhD in Organic/Medicinal Chemistry. Postdoctoral or pharmaceutical industry experience desirable; 4+(PhD with Postdoc) years of industrial experience Demonstrated high impact problem-solving as evidenced by publications and/or patents. Experience in synthetic methods development, target-oriented synthesis, chemical biology, and/or physical organic chemistry. Superior laboratory skills and proficiency in experimental design Familiarity with structure-activity and structure-property relationships Demonstrated ability to resolve key scientific hurdles by effectively utilizing available information and technical expertise. Excellent communication skills; ability to develop, implement and clearly communicate chemistry strategies and progress to team. Build strong relationships with peers and cross functionally with partners outside of teams to enable higher performance Key Leadership Competencies: Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance. Learns fast, grasps the "essence" and can change course quickly where indicated. Raises the bar and is never satisfied with the status quo. Creates a learning environment, open to suggestions and experimentation for improvement. Embraces the ideas of others, nurtures innovation and manages innovation to reality.
AbbVie Illinois, USA
Nov 16, 2019
Full time
AbbVie is seeking a highly motivated Associate Scientist to join our Drug Metabolism and Pharmacokinetics team in North Chicago. In this exciting role, you will be expected contribute to the success of drug candidates through phases of drug discovery and development. The ideal candidate will have a strong background quantitative laboratory methods and mammalian cell culture and possess ability to generate precise, reliable and reproducible data in a timely manner. Demonstrate strong data interpretation skills, ability to troubleshoot experiments and instrumentation, ability to learn and understand new experimental techniques and be able to place data in proper scientific context by consulting and citing relevant literature. Independently design and conduct critical experiments that further project goals. Implement and may innovate new experimental protocols/techniques. Independently schedule and prioritize workload to manage several tasks simultaneously. Identify and utilize resources outside of own group. Anticipate and adapt to experimental variability. Contribute key data to internal/external reports, documents and publications. Teach methods to others and make time to help other groups/projects with insight and know-how. Enhance performance through cooperation with groups outside project. Contribute key data to publications/reports/posters for external meetings as appropriate. Communicate and defend experimental strategies and results. Prepare written and oral reports of work. Applicants having significant experience in drug metabolism, pharmacokinetics or hepatocyte biology principles is desirable. The position will involve the conduct of routine and non-routine assays. Present data clearly and thoroughly in both one-on-one and group meetings with clear and precise graphs/charts/ tables. Provide written summary reports as appropriate. Learn and share knowledge with colleagues and participate in internal and potentially external poster presentation opportunities. Core responsibilities include: Conducting routine and non-routine ADME assays, generating high quality, reproducible, impactful data that enables decision making. Writing and reviewing reports suitable for regulatory agency submission Analyze and critique results, noting significant deviations. Troubleshoot experiments and instrumentation. Place data in proper scientific context by consulting and citing relevant literature. Independently design and conduct critical experiments that further project goals. Bachelor's Degree or equivalent education with 5+ years of experience, OR Master's Degree or equivalent education with 2+ years of experience. Theoretical and practical knowledge to carry out the job functions. Necessary skills include: Pipetting, cell culture, quantitative analysis. Effective oral and written communication skills. Experience in primary cell culture (e.g. hepatocytes), radioisotope work, electronic lab notebooks, would be advantageous.
AbbVie Sunnyvale, CA, USA
Nov 15, 2019
Full time
General Position Summary/Purpose: Contribute to multiple stages of development of targeted small molecules by supporting the implementation of scientifically driven development plans, primarily on setting up the strategy and executing on bioinformatics analysis of novel target discovery and biomarkers of interest for various projects. Practical knowledge and leadership experiences in experimental designs for preclinical and early clinical drug discovery projects. Develop, maintain, and refine bioinformatics workflows and analytical tools for preclinical and clinical biomarker data analysis. Current focus of this position is primarily on preclinical discovery biological research. Practical knowledge of bioinformatics tools and resources, experience with next generation sequencing (NGS) data, various high-throughput omics analysis pipeline development, integrative omics data and cloud computing, and strong background in genomics and molecular biology. As a member of our bioinformatics group working with other research scientists in a highly collaborative and dynamic environment to support biomarker investigations and translational medicine. Key Accountabilities/Core Job Responsibilities: Providing appropriate experimental design and biospecimen sampling scheme, molecular data analysis strategy and statistical support to identify mechanisms of action or resistance for small molecule therapeutics, identification of novel targets and candidate biomarkers for various programs and projects and other research objectives. Working with standard bioinformatics tools, visualization packages, and omics databases/annotations resources. Developing and using bioinformatics pipelines to prepare and analyze data, working closely with data engineers in pipeline developments. Analyzing and working with NGS data, ideally whole genome and exome sequence data and other omics data etc. Interpreting and translating data to biological knowledge. Presentation in internal group meetings or external scientific meetings Expertise and experiences in experimental designs. Demonstrated fluency in UNIX/Linux computing environment (8 years) Proficiency in R programming (8 years), other programming skills such as in C/C++ and a scripting language such as Perl or Python would be desirable. Familiarity with SAS, JMP or JMP Genomics, OmicSoft ArraySuite are a plus. Excellent working knowledge of current best practices in genetic variant discovery and validation methods. Strong organizational, written, and communication skills. Excellent analytical and problem solving abilities. A proven track record in scientific publications and invited presentations at major conferences on target discovery and biomarkers. Knowledge of cellular and molecular biology, oncology, and drug development processes. Enjoys working in a fast paced and highly collaborative dynamic environment with a diverse team to tackle complex problems. Eager to learn and think outside the box. Is disciplined and driven to deliver ongoing research results. Has a positive attitude with a willingness to roll up their sleeves and do what it takes to get the job done. Is highly organized and detail oriented. Is a strong written and verbal communicator. Has a hard work ethic with emphasis on execution. Education Requirements (degree, certifications, etc.): Include must have and preferred PhD in Bioinformatics, Computational Biology, Statistical Genetics/Genomics, Computer Science, Statistics/Biostatistics with strong molecular biology background, and industry experience preferred. Preferred Skills/Abilities Experiences in developing small molecule therapeutics for oncology or immunology or immune-oncology Strong understanding and proven track record in genomics/genetics technology and applications to clinical development.
AbbVie Sunnyvale, CA, USA
Nov 15, 2019
Full time
General Position Summary/Purpose: Responsible for conception and implementation of overall biomarker strategy and development plans to support early stage clinical programs in AbbVie's oncology pipeline and portfolio. Directs pharmacodynamics, mechanisms of action/resistance, patient selection, safety and other clinically relevant biomarker studies through external CRO and internal efforts. Collaborates closely with Discovery, Clinical Science, Data Science, Clinical Operation, and Regulatory Departments to deliver biomarker results/reports to internal stakeholders and external regulatory agencies. Ensures that overall budgets, schedules, and performance standards are attained. Accountable for the operational execution of biomarker strategy in oncology clinical studies, in compliance with AbbVie's processes and regulatory requirements. Key Accountabilities/Core Job Responsibilities: Works in the Translational Oncology Department to develop, establish, and lead efforts aimed at exploring novel biomarkers with association to clinical endpoints in early stage oncology studies. Leads cross-functional Translational Oncology Working Group to drive biomarker analyzes using a deep biological understanding of clinical genetics, cancer biology or immuno-oncology. Undertakes cross-functional engagement with Clinical Science and Clinical Operations for implementation of biomarker assays in the clinic. Manages relationships with external analytical labs, provide input into trial-specific agreements and perform technical assessment of labs involved in biomarker sample analysis. Coordinates between CRO Assay Development group and clinical team, when necessary. Provides input on biomarker-related sections in clinical study-related and regulatory documents (such as Clinical protocol, INDs, IBs, etc.). Contribute to the biomarker assessments in clinical protocols to develop the central and reference laboratory components. Participates in reviews and provides recommendations for business development opportunities. Ensures that biomarker samples selection, data transfer, analyzes and reporting are performed in accordance to the study protocol and in compliance with regulatory requirements. Participates in drafting of clinical study-related and regulatory documents, such as INDs, ICFs, IBs, Clinical Study Reports, ad hoc analyses, etc. BS or equivalent education and extensive, typically 14+ years of experience; MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of experience in area or scientific area of discipline Demonstrated ability to function as a principle investigator, generating original technical ideas and research or development biomarker strategies. Demonstrate creative 'out of the box' thinking to solve difficult technical problems and champion new technologies to achieve project goals. Ability to multitask and work within timelines. Experienced and demonstrated success as primary author of publications, presentations, regulatory documents and/or primary inventor of patents. Demonstrated scientific communication and presentation skills by presenting at leading scientific conferences. Recognized and sought out as an expert in his/her discipline within the company and possibly externally. Proven record of success in leading clinical biomarker studies in Biopharmaceutical companies, preferentially in oncology settings.
AbbVie North Chicago, IL, USA
Nov 15, 2019
Full time
This position is responsible for the timely processing of Shopping Carts / Administrative Check Requests (ACRs) / Requisitions within SRM/ECC to ensure the on-time delivery of necessary goods and services needed to support the business. Works closely with Purchasing Agents and Category Managers in maximizing value on all AbbVie purchases. The Purchasing Assistant works on the definition and resolution of known problems in value, quality, feasibility, compliance and specifications in the procurement of goods and services while contributing cost savings and other value added activity to support customer needs and expectations. This position interfaces with suppliers and AbbVie employees at levels up to and including Vice Presidents in the businesses they service. This interface is to confirm, follow up and resolve any nonconformance's to the order requirements. The expenditures directly impacted by this position are described in CFM 60, Level I. As of issue date, purchase authority up to $100,000. Major Responsibilities: Knowledge and Skills Demonstrates basic knowledge of the purchasing process (e.g. Purchasing policies and procedures, ECC/SRM, and vendor master management). Demonstrates critical thinking and problem-solving skills Demonstrates clear and concise written and verbal communication skills. Possesses ability to work within team environment. Project / Process Management Manage and process SRM shopping carts/ SRM ACRs / ECC requisition queue to ensure timely processing of POs Ensure shopping carts, ACRs, requisitions, and POs include the required documentation, correct category code, and are compliant with purchasing policies and procedures Demonstrates the ability to prioritize and multitask to enhance productivity and manage workload. Participate in invoice resolution in regards to changing purchase orders as needed. Participates in purchasing compliance reviews Client Management Acts as an interface for purchasing internal customers regarding PO status Encourages and develops positive relationships between key internal clients and suppliers Identifies and elevates conflict to facilitate resolution. Responsible for compliance with applicable policies and procedures. Education High School diploma required. College Degree: 2 years college, business school equivalent or equivalent job experience is desired 3+ years total combined minimum years of experience required in areas such as Purchasing, Accounts Payable, accounting Customer Service, Materials Planning, Supply Chain, Finance, or other business related experience Computer applications (word processing, spreadsheets, and presentations). Planning and organizational skills Demonstrated ability to multi-task. Strong communication and interpersonal skills. Key Stakeholders: - Purchasing Agents, Category Managers, Managers and Directors, Internal Purchasing customers, suppliers
AbbVie Roanoke, VA, USA
Nov 15, 2019
Full time
This individual will be responsible for developing and maintaining strategic business relationships with Oncology departments and practices consisting of interactions with Oncologists, Hematologists, nurses, executive level personnel, marketing, department managers, Healthcare Providers and various other physicians and support staff. Business relationships will be focused on increasing education on product benefits/risks consistent with approved label, developing new business, improving resource utilization, and growing sales and market share by achieving sales plan for the assigned Oncology product portfolio. Learn more about this role and what it takes and what we are looking for as an Account Executive within Oncology! Key Responsibilities Include: Uses opportunities to understand and address customer needs! Builds strong relationships that provide market intelligence and support development of compliant and innovative programs and initiatives. Builds and maintains relationships across accounts that result in opportunities to benefit patients, physicians, and other HCPs within the geography. Consistently partners with in-house and/or cross-franchise leaders, and collaborates with such partners to identify, design and/or adapt appropriate approaches and tactics demonstrating resources within geography. Delivers effective on-label technical and scientific presentations utilizing approved data, to include supporting data, to appropriately highlight the benefits and risks of the product resulting in sales quota achievement. Serve as lead US Commercial contact with targeted accounts in assigned geography and collaborate with all AbbVie and any co-promotion Counterparts including Marketing, Managed Care, Hematology Clinical Coordinators, Thought Leader Liaisons, and contracted SPPs to provide excellent customer support for physicians to the benefit of their patients. Such support should include site support and addressing any potential customer issues. Build, implement and communicate strategic and tactical plans for targeted accounts. In collaboration with sales leadership and other appropriate AbbVie or Co-Promote partners, facilitate site physician/treatment team training on approved and safe use of AbbVie's products. Monitor and report sales progress. Provide routine communications to all internal and external (as applicable) partners. Act as AbbVie key point of contact to each account. Respond to or direct customer to the appropriate service or point of contact for their questions or requests and actively follow-up. Take lead in coordinating and ensuring any needed or requested support is delivered in a timely manner and to the satisfaction of the account. Attend and actively participate in local clinician boards, societies, meetings and the like. Represent AbbVie and assigned products at such venues, build/improve new/existing relationships. Channel key information, developments or findings to internal partners/stakeholders. All communications in these forums are on-label. Remain current on all clinical, market, and payer developments, tends, and issues specific to oncology. Complete all AbbVie required training and maintain adherence to all company policies and OEC/Legal procedures. Within assigned accounts and geography, seeks out important information and articulates implications to our business and to our customers' business'. Transfers knowledge to appropriate internal partners and integrates standard methodologies that have tangible value for customers and patients across assigned brands to benefit the geography. Establishes and maintains a complete understanding of approved product label and disease state knowledge for impactful use with customers. Optimizes both external and internal data, resources, and tools to identify sales opportunities and program strategy for customers in assigned territories. With the approval of legal/OEC, actively participates in relevant organizational programs in local markets. Develops a strong command of available selling resources and tools; fully demonstrates those resources to support selling strategies and maximize impact. Provide all physician detailing using AbbVie approved materials and in accordance with all of AbbVie's policies and procedures. An essential requirement of your position is to meet health care industry representative (HCIR) credentialing requirements to gain entry into facilities and organizations that are in your assigned territory. These HCIR credentialing requirements may include, but are not limited to, background checks, drug screens, and proof of immunization/vaccination for various diseases. Basic: Bachelor's degree 3+ years Oncology or Specialty Pharmaceutical Sales/Account Executive experience. Knowledge of applicable regulations and standards affecting Pharmaceutical Products Strong eye for business; analytical ability to analyze diverse sets of data using multiple tools and define account/program strategies that drive business objectives. Must demonstrate an understanding of how to effectively meet customer needs in a complex environment through forward-thinking, innovative strategies that align with the company and customer objectives. Effectively demonstrate leadership skills; ability to lead without direct authority. Has experience with successfully developing teams on complex projects or challenges to achieve results. Excellent communication and presentation skills. Preferred: MBA 5+ years Oncology or Specialty Pharmaceutical Sales/Account Executive experience. Experience operating in a Specialty Pharmacy Provider environment. Oncology and/or account management experience. People management or other leadership experience
AbbVie Illinois, USA
Nov 15, 2019
Full time
The RINVOQ (upadacitinib) SpA Associate Director (AD) will lead key elements of launch planning for additional indications in spondylarthritis (SpA) - psoriatic arthritis (PsA) and ankylosing spondylitis (AS). The AD will coordinate across both internal and external stakeholders to enable an integrated and successful launch. Strategic elements of the role will include everything from deep understanding of customer insights through engagement strategies to closed loop marketing. The AD will be responsible for elements such as synthesis of market research insights and clinical data, portfolio positioning strategy, segmentation, brand development, creative campaign ownership and innovative tactical execution. Importantly, the AD must be able to operate in an environment of change and uncertainty, maintain highly collaborative relationships across a large variety of cross-functional partners, and be proactive in bringing solutions to the forefront. Job Description - The responsibilities of this role are listed below but may shift based on launch needs. RINVOQ clinical profile - the AD will be charged with deeply understanding clinical data across trials, within a cluttered future competitive environment, with the goal of making strategic trade-offs on key product strategic pillars and promotional messaging. This individual will be the primary brand conduit to global and US medical affairs to ensure customer needs are understood as the medical team develops plans for publications. PsA and AS market environment - this person will be responsible for thoroughly understanding broad market dynamics, current/future trends, competitors, and white space opportunity for future entrants. The AD will also partner closely with marketing analytics and business insights as well as other cross-functional partners to garner rich understanding of all customer segments, their attitudes, motivations and behavioral drivers to be able to identify meaningful activating insights. Portfolio development - this individual will be responsible for leading the strategic marketing development for the portfolio of products we will bring to rheumatologists. He/she will be responsible for identifying the opportunities to cross-promote both HUMIRA and RINVOQ and the strategic approach to applying the segmentation in a simple and executable fashion that is aligned and understood by all key stakeholders. EE engagement - the AD will oversee all elements of external expert engagement, including gaining feedback through advisory boards, as well as congress management. Sales force engagement - the AD must partner closely with the sales force and sales training to develop comprehensive and effective tools that will allow for a strong launch. Senior leadership engagement - the AD will collaborate closely with the director on a host of scheduled and impromptu launch updates to make sure that confidence in launch planning remains high, that we seek advice/decisions at appropriate times, and that we are showcasing integration of launch planning across functional teams. Label strategy - this individual will also partner with the director in collaborating with the Regulatory team to ensure a robust US label, providing input on key Regulatory milestones, including FDA discussions and NDA filing. Brand strategy and creative development - individual will oversee the core brand development team to develop key pillars of the brand including the global campaign, including differentiation strategy, global imagery, and global core message elements. 360-degree promotion - this individual will lead in the development and implementation of a '360-degree promotional plan' for RINVOQ. The person will develop a strategy to create a closed loop marketing environment around our HCP customers that includes all channels including the salesforce. This person will need to work closely with key internal stakeholders to enable data to help drive more decision making at the individual HCP customer. Maintain and support a positive team culture - the AD will partner closely with all members of the IBT, R&D, global teams, and agency partners to ensure he/she understand all elements of the launch, ensuring partnership and a seamless, integrated approach. Lead competitive assessment and implications that are relevant for specific indications Effectively track and manage the marketing budget. This individual will report to the Marketing Director, RINVOQ SpA. Basic: BA/BS Required, MBA Preferred. 4+ years of relevant brand marketing experience Demonstrated success in previous Marketing roles and HCP related projects. Experience leading vendor or agency of record partners Strong analytical/problem solving and effective communication skills Apply marketing concepts in the development of marketing plans and programs including brand positioning, brand architecture, SWOT analysis, competitive assessment, market research, marketing objectives/strategies, HCP segmentation, etc. Strong planning and organization skills, attention to detail, execution, and follow-through Ability to work with all levels in a highly matrixed organization. Preferred: Strategic thinker with entrepreneurial characteristics Strategic and tactical planning experience Sales experience
AbbVie North Chicago, IL, USA
Nov 15, 2019
Full time
Achieves cross functional collaboration establishing a strong understanding of the patient and global standard of care, leveraging relevant external and internal insights, and translating into actionable global recruitment and retention strategies to achieve study commitments Enables utilization of "Big Data" resources to inform clinical development programs, including site and patient geostrategy, patient inclusion/exclusion criteria, and patient recruitment and retention strategies Supports the application of risk-based thinking to clinical trial recruitment, identifying risks and establishing effective mitigation strategies to enable successful execution of the therapeutic area portfolio, and to establish effective programmatic strategies and resources to build for future success Enables the application of patient- and investigator-centric thinking within the clinical programs, ensuring that programs are seeking and incorporating insights from key external stakeholders in clinical development and study planning Maintains compliance with ICH GCP Guidelines, AbbVie Quality System and local and worldwide regulatory requirements; Ensures global compliance with corporate and divisional policies and procedures Keeps up to date on emerging and changing technologies, regulations, policies, and approaches with regards to patient recruitment. May represent AbbVie at external conferences regarding patient recruitment and retention Supports the development, maintenance, and effective training of the organization on patient recruitment and site engagement related standard operating procedures and policies Supports multi-year resource planning, budgeting and recruitment model/strategy to meet the needs of the therapeutic area(s) and drive cost efficiencies Serves as the Therapeutic area expert on industry best practices related to patient recruitment and retention Fosters a culture of continuous process improvement. Growth and development of direct report s Bachelor's Degree in a scientific field required, Advanced degree preferred Minimum of 6 years + of pharma-related/clinical research experience with direct experience in patient recruitment and retention, and project management experience, or equivalent Leadership skills in a cross-functional global team environment with ability to influence and align stakeholders, and be a model and driver of AbbVie's leadership attributes Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making. Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity Expertise in drug development, operations and resource/budget planning across global geographies
AbbVie Illinois, USA
Nov 15, 2019
Full time
AbbVie is a global, research-based biopharmaceutical company whose mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Job Description Discovery Platform Technologies has an opening for an Associate Scientist II/Scientist I in the Analytical and Purification Sciences group. This position will provide opportunities to devise innovative solutions to complex analytical and separation problems through the implementation and utilization of sophisticated instrumentation. Key Responsibilities Include: Chiral analysis and purification of samples using supercritical fluid chromatography (SFC) and developing methods for the resolution of racemic drug molecules on milligram to gram scale by preparative chiral SFC Operate and maintain novel instrumentation for the analysis and purification of compounds from medicinal chemistry projects using SFC and HPLC Maintain a high level of productivity in the laboratory setting Demonstrate a high degree of responsibility in maintaining scientific standards, and safe laboratory practices for self and reporting staff, if any Keep accurate and current records of research and/or project related activities according to AbbVie policies. Basic: MS, or BS in Organic Chemistry, Analytical Chemistry or closely related field with 0+ years (MS); or 2+ years (BS) of job related experience Hands-on experience with analytical HPLC/SFC, preparative HPLC/SFC, and mass spectrometry Ability to operate and troubleshoot a variety of hardware/software platforms Proven effective written and verbal communication skills and ability to interact effectively with scientists and engineers Preferred: Experience in synthetic organic chemistry and the ability to communicate effectively with medicinal chemistry project teams Experience with instrument troubleshooting and maintenance Key Leadership Competencies: Strong interpersonal and communication skills with demonstrated ability to work within a team environment Learns fast, grasps the "essence" and can change course quickly where indicated Raises the bar and is never satisfied with the status quo
AbbVie Worcester, MA, USA
Nov 15, 2019
Full time
The Biologics Generation Group within Global Biologics is seeking a highly motivated research scientist to join the in vivo antibody discovery team at AbbVie Bioresearch Center (ABC). The ABC site, based in Worcester, MA, offers the unique setting where Biologics drug discovery, development and manufacturing coexist in one location! Our team interacts with multidisciplinary groups across AbbVie focused on developing therapies for Immunology, Neurology and Oncology diseases. We utilize innovative immunization approaches, advanced multiplex screening assays and outstanding automation platforms to enable successful antibody discovery against complex targets! As an integral part of the group, the ideal candidate will: Exercise proficiencies in mammalian tissue culture, molecular techniques, and binding assays such as ELISA and flow cytometry Execute all phases of in vivo antibody discovery campaigns by hybridoma generation or single cell isolation including immunizations, screening, cell culture and antibody characterization Analyze and document results, placing data in accurate scientific context through review of relevant literature and report findings at team meetings Demonstrate scientific excellence through dedication to multiple projects in a fast-paced multi-disciplinary environment Exhibit a can-do attitude with excellent interpersonal and communication skills to multiple teams across different functional areas Position will be hired based on knowledge and/or level of experience. Bachelors or Masters in Biology or other closely related field with typically 3-5+ (BS), or 0-3+(MS) years of industry or academic experience Knowledge of basic immunology concepts Understanding of immunoassays (e.g. flow cytometry and ELISA) Strong attention to quality and details when exercising organizational, documentation and interpersonal skills Proven flexibility to take care of changing timelines and shifting work priorities Proficiency with software programs, including MS Excel, PowerPoint, Word Preferred Qualifications: Experience with mammalian cell culture, aseptic technique is highly desired Experience in immunoassays using techniques like flow cytometry, ELISA and microscopy Animal handling experience (e.g. restraint, immunizations, tissue harvesting etc.) Familiarity with microfluidics and single cell analysis platforms
AbbVie Sunnyvale, CA, USA
Nov 15, 2019
Full time
General Position Summary/Purpose: The IT R&D Lab Application Manager will ensure solutions delivered by the IT department comply with 21 CFR Part 11, 68, 210/211 and other regulations and best practices within the pharmaceutical/biotech industry. This individual will be involved with designing and implementing GxP Lab systems working closely with Business Partners. The Technical Lead will need to follow established change control processes while supporting Lab applications. The IT R&D Lab Application Technical Lead will be a valuable member of the Laboratory and IT teams. They will recommend improvements to current-state and be responsible for implementing solutions that meet the future-state requirements. In addition to supporting the Labs, the IT R&D Lab Application Technical Lead will also contribute to driving innovation and seeking new technical solutions for R&D. The goal of the Lab Support team is to ensure that lab systems are online and available for use by the Business. This role has an emphasis on systems administration for client/server systems, including: system design, client/server hardware & software installation, ports/protocols/firewalls, networking, and troubleshooting. In addition, this role will require appropriate skills to document the current/future state for systems and transferring these systems to operational support by the Tier 1/2 teams. Core Responsibilities: Senior System Administrator for GxP Lab Applications such as Empower, OpenLab, Omnic, Insight, SLIM, Vaisala, and other similarly classified applications. Lead a team of System Administrators and coordinate operational activities with the Managed Services team responsible for daily support of these applications. Will be the Technical Lead for the lab team as an escalation point for technical issues that require advanced understanding of Windows Systems Administration techniques and best practices. Technical Lead for Computer System Validation projects for GxP Lab Applications. Will be an active part of the lab support team, but as Technical Lead, they will have the authority to delegate tasks within the team as needed. Provide backup support and guidance to System Administrators on an as needed basis. Will create recommendations, project plans, budgets, and reports for continuous improvement of laboratory systems support. Will work closely with lab support team and vendors to install new systems. Will assist with architecture design for new systems and applications. Will assist with upgrading systems OS, apps, and related technology (switches, UPS, etc.) Will evaluate lab systems and recommend path to upgrade to ensure systems are under warranty and/or support. Will have a solid understanding of networking, security, databases, applications, and development. With a stronger than average skill set in at least one of those areas. Will be responsible for routinely creating and presenting proposed Changes to the Change Review Board. Will support lab customers by using ServiceNow to respond to incidents and requests. Will routinely review all tickets resolved by the team to ensure they are accurate and complete. Will follow established policies and procedures. Will create content for Knowledge Articles, SOP's, Policies, Work Instructions, etc. Familiarity or experience with laboratory data management platforms such as electronic lab notebook and results & analysis platforms (e.g. STARLIMS). Oversight of Laboratory Systems requirements and configuration definition. Ability to support critical Lab Application such as Waters Empower CDS. Ability to review and update policies, guidelines, and procedures relating to computer system validation. System Administration in a regulated environment with appropriate Change Management processes. Ability to develop solutions to complex problems that require a high degree of ingenuity, creativity, and innovation within the boundaries of industry (e.g. compliance with regulations). Process mapping to identify and recommend business process improvements. Assisting in solutions identification, evaluation, selection, implementation, testing, and working with the IT technical delivery team(s) to meet business requirements. Knowledge of validation lifecycle of lab GxP computerized systems. Prepare, execute, and finalize the validation of computerized systems to be used in the production or development of pharmaceutical products. Assist with GxP and Non-GxP system configuration and general IT duties as needed. Assist in Lab Expansion projects; work with designated teams during Regulatory (and Internal) Audits and Inspections. May be required to travel (approximately 5-10%). With core competency focused in: Leadership capability focusing on relationship management, influencing decision making and resolving conflicts. Strong core IT fundamentals background accompanied with knowledge of information systems & workflows for lab assay data & knowledge management, data query & analysis, lab automation & LIMS, sample management, bio banking, and inventory. Familiar working in a Research & Development lab (or similar) to ensure safe operation when working around chemical and biological hazards. Proper Protective Equipment and lab safety guidelines are followed at all times. Install, configure, and maintain computer systems in compliance with relevant policies, guidelines, and procedures. Coordinate downtimes for project related upgrades, updates, and configuration changes. Skills: The IT R&D Lab Application Manager shall partner with Business Owners/SME's, Business QA, IT Compliance and end users with differing levels of technical expertise. Ability to take projects from design to long-term maintenance. Excellent communication and documentation skills. Good presentation skills to clearly communicate technical concepts with a high degree of precision to technical audiences. Ability to explain complex concepts in simpler terms for other audiences as needed. Expected to deliver documentation and training with all solutions. Ability to plan and coordinate multiple simultaneous application efforts. Quick learner, self-starter, tenacious problem solver, and highly motivated. Advance understanding of Microsoft Windows 7, 10 and Server 2008 R2, 2012, 2016 PowerShell fundamentals Citrix fundamentals System Administration, Management, and Automation Writing, reviewing, and executing validation documents within the Computerized System Validation framework. GxP Lab and instrumentation support background and experience. Experience with automation, scripting, and development Familiar with drug discovery, translational medicine, and the IND/NDA process. Familiar with electronic ticketing and document management systems such as: ServiceNOW, MasterControl, and Trackwise. Computer System Validation and the Change Control Process in Life sciences industry. Advanced user of Office and other productivity applications: Access, Word, Excel, PowerPoint, Outlook, InfoPath, Project, SharePoint, SmartSheet, PowerBI, etc. Bachelors Degree or an equivalent combination of education and work experience. 10-12 years of related work experience. Exercises latitude in the approach to problem solving. Determines and develops approach and solutions to problem. Working knowledge of 21 CFR Part 11, 68, 210, 211; Computer Systems Validation and GAMP framework. Must understand these regulations and be able to deliver compliant solutions.
AbbVie Illinois, USA
Nov 14, 2019
Full time
The Associate Director, Global Market Access & Pricing - Venetoclax & Pipeline primary function is responsible for: Developing and implementing global market access, pricing and reimbursement initiatives and tactical plans aligned to the Integrated Access Strategy of R/R CLL Develop the Integrated Access Strategy for Venetoclax in Mantle Cell Lymphoma (MCL), including global market access and reimbursement initiatives and tactical plans suitable for this indication Provide support for hematology pipeline assets in development. Ensuring critical clinical and economic evidence requirements to ensure PRA success are incorporated into the development plan and translated into PRA resources for use by Areas and Affiliates with external stakeholders This position supports the Director, Global Market Access & Pricing - Venetoclax in payer value propositions/stories and ultimately as we approach launch providing tools and support to the market access teams in Areas and Affiliates. The position works closely with Area and affiliate personnel in determining appropriate responses/actions to developmental milestone decision points with regards to implications for local pricing and/or reimbursement issues. This person will also work closely with the Pricing and Analytics Team within Global Market Access& Pricing to track development of competitor pricing. The Associate Director, Global Market Access & Pricing - Venetoclax is to work cross-functionally to maximize deliverables within the budget allocated and drive a remarkable impact for patients through optimized patient access, while ensuring compliance and risk management. This individual will exemplify AbbVie leadership principles and provide innovative, strategic, and evidence based supported direction as the subject matter expert in reimbursement and market access opportunities and challenges. The position requires strong analytical skills, the ability to understand and translate clinical information and messages into payer marketing messages, strong presentation skills and the ability to work well in a cross-functional team. This position requires a deep understanding of the clinical aspects and the impact of these clinical results on the value of products, as well as the competitive products in this market space. In addition, this position is responsible for the oversight of the vendor management aspects, logistics, budget management, financial compliance, reconciliation and required transparency reporting for any/all market access and pricing projects managed, including alignment with finance, OEC, legal and commercial support groups. Key responsibilities include: In collaboration with the Director, Global Market Access and Pricing - Venetoclax, leverage Evidence Based Medicine expertise and clinical background, deep global payer knowledge, research and competitive insights to maintain and refresh the launch tools for R/R CLL which include GVD, communication tools and training for R/R CLL Generate global payer value proposition for MCL which is aligned with the product's total emerging value proposition (physicians, payers, and patients) and the product's target product profile. Collaboration with other GMAP functions such as Pricing and HTA Strategy as well as GHEOR, Global Business Intelligence, Government Affairs, Global Marketing, Global Commercial Development, Global Medical Affairs and complimentary Area & Affiliate Functions, to ensure solid understanding of global payer markets and emerging stakeholders in the reimbursement area. Through internal collaboration and management of external partners/vendors conduct pertinent therapeutic and disease areas reviews, and advisory boards, which includes but not limited to general market access landscape, payers unmet needs, current standard of care, competitors' value proposition and pricing & reimbursement status, and payers' decision. Assist in project management with regards to purchasing support, opening of POs; ensuring appropriate documentation is in place in line with company procedures and storage of pertinent documents to assigned projects. Basic: BA/BS in pharmacy, economics, life sciences or comparable equivalent experience Proven track record of being able to successfully interact with all levels of area, affiliate and internal authority across divisions (including Global Commercial Leaders, Forecasting, Clinical Development, HEOR, Medical Affairs and Regulatory, as well as peer equivalents in other market access teams and the market access community as a whole). Must be up to date on the latest compliance issues pertaining to Corporate guidelines, interactions with HCPs and External Experts and the conduct of market research The candidate must possess strong leadership, intrapersonal, critical thinking and analytical skills to work with a variety of groups in ensuring that the strategic direction for market access and pricing is in balance with the market as well as corporate goals. The candidate must be willing to work across a range of products, in pipeline, near market and on market in a variety of therapeutic areas, as needs dictate. The candidate must be sensitive to cultural and market differences as they will interact and travel to multiple countries in their role. This candidate must have strong presentation and writing skills. The candidate must have at least 8 years of progressive experience preferably in a variety of areas including market access, managed care marketing, key account management, payer support, commercial marketing, HEOR, pricing and reimbursement, and payer policy Preferred: MBA, MS, Pharm D, or other advanced degree preferred. A Background in managed care, payer marketing, global market access policy, or a related field is preferred Strong interest in clinical and health economic data is desirable Understanding of regulatory agency requirements / policies that govern market approval, and the impact on reimbursement decisions Knowledge of pricing regulations, pricing governance in key global markets, standard operating procedures, and the business of healthcare in key markets Experience across multiple therapeutic areas including Oncology is highly desirable
AbbVie Worcester, MA, USA
Nov 14, 2019
Full time
Our Immunology Discovery organization at our AbbVie Bioresearch Center located Worcester, MA is responsible for the identification of new therapeutic approaches for the treatment of autoimmune diseases! We have an exciting opportunity for a dynamic and innovative in vivo pharmacologist to join our team! While reporting to the Director of Pharmacology, your responsibility will be to guide a team of scientists working in models of arthritis and SLE. Key Responsibilities: Provide strong scientific, technical, and organizational leadership to drive drug discovery in rheumatoid diseases such as arthritis and SLE. Provide detailed knowledge of the pathophysiologic mechanisms of rheumatic diseases and apply this knowledge to implement new concepts and methodologies for the development of drug candidates. Drive excellent performance of group by effectively leading both direct and indirect reports including recruiting, managing, mentoring and developing scientific staff Contribute to defining research team goals by collaborating with scientists within and outside functional area and driving the success of the Immunology portfolio. Excellent interpersonal skills and the desire to succeed in a collaborative work environment are required Position will be hired based on level of experience. Bachelors, Masters, PhD, or DVM, or equivalent education in biological sciences with typically 16-18+ (BS), 14-16+ (MS) or 8-10+ (PhD) years of experience; Industry experience preferred Experience in applying mechanism of action studies, PK/PD, and disease systems to successful drug discovery programs is required Strong working knowledge in immunology is essential Established track record of successful drug development experience. Recognized pharmacology leader with in-depth knowledge of in vitro and in vivo model systems and the ability to build PK/PD correlations Experience in managing direct reports and development of scientific staff with positive team building and teamwork skills Evidence of critical thinking and portfolio management is required Ability to lead and maintain scientific business relationships and to establish contract research agreements Strong written and oral communication skills Excellent publication record
AbbVie Worcester, MA, USA
Nov 14, 2019
Full time
The candidate will lead a downstream team within the Scale-up Lab in supporting early to late stage biologics API manufacturing. The candidate will be primarily responsible for a variety of downstream initiatives (i.e. capture and purification) including; Generation of GLP-tox drug substance/intermediate to support preclinical activities Evaluation, development, and implementation of novel manufacturing technologies (e.g. process intensification, PAT, multi-column chromatography, etc.) Scale-up and tech transfer of biological processes to GMP production Author/review GLP batch records and technical reports Education Requirements, Number of Years Experience, Specific Skills: Bachelor's Degree or equivalent education and typically 10 years of experience, Master's Degree or equivalent education and typically 8 years of experience, PhD and no experience necessary. Desired Skills: Has demonstrated success of independent scientific thought through the design and execution of experiments to solve technical challenges. Demonstrated people leadership skills and ability to manage scientific teams. Agility and accountability of timely deliverables with a highly dynamic schedule. Excellent communication, writing, and presentation skills are expected.