Global Blood Therapeutics

Global Blood Therapeutics San Francisco, CA, USA
Jan 28, 2020
Full time
IT SECURITY AND GOVERNANCE ANALYST Job Summary: The IT Security and Governance Analyst will be responsible for the day-to-day security threat monitoring and analysis from endpoint security, enterprise servers, infrastructure devices to our cloud-based applications. The IT Security and Governance analyst will also work with IT Security management on developing, implementing, and managing security controls and defenses related to the execution for the IT Cybersecurity Program, including Intrusion Detection, Log monitoring, Vulnerability assessment, and Incident Response & Reporting. Essential Duties and Responsibilities: Assists in the creation and implementation of security solutions in areas including but not limited to: IAM Network, application and endpoint security Threat Detection Data Loss Prevention Incident Response Evaluates system security configurations to ensure efficacy and compliance with policies and procedures Participates in Incident Response engagements and provides guidance on tactical and strategic response and remediation recommendations Performs operational review, triage, and response to cybersecurity alerts, identify intrusions, provide analysis, determine and track remediation and escalates to the IT Security management team as necessary Interfaces with external security vendors and service providers Researches and evaluates cybersecurity threats and performs root cause analysis In collaboration with Finance and auditors, develop and maintain SOX IT General Controls (ITGC) and deliver regular reporting Support compliance remediation efforts, impact analysis, and documentation Assist in developing and maintaining cybersecurity procedures, standards, controls, and metrics based on the NIST framework and regulatory compliance requirements Act as an advocate in support of Security Awareness and works with the organization to promote good security practices Qualifications: BA/BS in computer science, management information systems, or an equivalent combination of education and experience that demonstrates analytical skills, problem-solving, initiative, judgment, decision making, and writing ability A minimum of three (3) years of relevant experience Demonstrates knowledge and understanding of computer security concepts including Identity & Access Management (IAM), Network Security, Application Security, and Incident Management Prior experience of tools and products used in day-to-day performance of job responsibilities (i.e. SIEM, CASB, PAM) Experience in information security, risk assessments, and cybersecurity frameworks (i.e. NIST CSF, CIS, SOX ITGC) would be beneficial Ability to research, develop, and keep abreast of tools, techniques, and process improvements in support of security detection and analysis by following current and emerging threats and attack vectors Ability to take on additional tasks as defined by IT Security management team Specific experience in the pharmaceutical and/or health care industry with specific FDA regulatory compliance experience is desirable Strong interpersonal communication skills and the ability to work effectively with a wide range of constituencies in a diverse community Self-starter - takes initiative and is solutions-focused and can work with minimal supervision Ability to effectively prioritize and execute tasks in a high-pressure environment Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Global Blood Therapeutics South San Francisco, CA, USA
Jan 27, 2020
Full time
SENIOR ADMINISTRATIVE ASSISTANT, FIELD SALES TEAM Position Summary: Reports to VP, Sales; Provides administrative and operational support to the Field Sales team (and other field organizations) as outlined and/or needed. The ideal candidate will thrive in a service and support role and is highly detail-oriented. Essential Duties and Responsibilities: Provides encompassing administrative support to the VP Sales (and their direct reports) Proactively manages and maintains VP Sales calendar; arranges travel, travel expenses, organize meetings at their request, etc. Provides administrative and operational support to Field Sales organization Be the first point of contact for the Field Sales organization (field sales leaders and field sales professionals) Must be able to prioritize and manage multiple projects simultaneously including: Be the Field Sales organizations first point of contact for training/trouble-shooting any in-house support needs Coordinate on-boarding/off-boarding of field sales employees (work cross-functionally with HR, IT, Sales Ops, Training, etc.) to ensure employees receive (or return) their equipment and access Manages Field Team/Rep Rosters (that feed into internal systems); coordinates with internal partners to maintain Audits, processes and triage exhibit, sponsorship/display applications; communications payments back to the field organization Supports meetings/events lead and training lead as needed in the planning of field sales off-cycle meetings, regional based and training meetings Provides meetings operational/admin support to training lead as it relates to executing HQ-based training events Will eventually become point of contact for, and maintaining/processing credentialing requests Handles confidential material with discretion and professionalism Handles special projects as requested Qualifications: A minimum of 4 years of administrative experience (biotech preferred) in increasing positions of responsibility Strong knowledge of MS Office; Excel, Word, PowerPoint, Outlook Excellent verbal and written skills and attention to detail Ability to juggle multiple priorities and manage complicated calendars across multiple executives and external personnel Ability to work independently and be flexible, adjusting priorities and tasks in real time to support the objectives of the departments Successful experience in fast-paced, high growth environment Proven ability to handle confidential material with discretion and professionalism Must have excellent customer-service orientation, high degree of professionalism, and be a strong team player Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Global Blood Therapeutics San Francisco, CA, USA
Jan 26, 2020
Full time
CONTRACT - CLINICAL TRIAL ASSISTANT - 2 POSITIONS Job Summary: The Clinical Trial Assistant (CTA) is responsible for providing support to the lead Clinical Trial Manager and the study management team, clinical tracking and document maintenance as applicable to study vendors and clinical trial sites. The CTA will work closely with a cross-functional team to ensure that clinical trials are conducted in a timely fashion and in compliance with GBT SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets. The CTA must work well under pressure and can meet multiple and sometimes competing deadlines. The CTA must demonstrate cooperative and professional behavior with colleagues and vendors. The CTA should be able to show flexibility with changing project-specific priorities. Essential Duties and Responsibilities: Performs general administrative functions such as clinical trial tracking, providing logistical support to one or more study management teams (SMTs), scheduling meetings and/or travel arrangements for clinical staff, requesting proposals/contracts from CROs, tracking and managing distribution of non-clinical supplies throughout the course of the study Tracks and maintains study information and reports on study progress Tracks and provides IRB/IEC submission documentation and other supplementary documentation as appropriate Obtains, reviews, processes, and tracks study related documents (CVs, FDA 1572s, lab certifications, IRB approvals, contracts, protocols, etc.) Maintains and ensures the completeness of the Study Level Trial Master File (TMF) in accordance with SOP requirements Serves as key central contact for communications, correspondence and associated documentation. Performs duties such as, clinical form design, and filing of correspondence, lab reports, clinical monitoring reports, and other study documents Maintains and ensures all documentation is in a state of audit-readiness Responsible for collection, dissemination, and/or tracking of regulatory documents as required Maintains accurate tracking and reporting of study management data Maintains and disseminates basic study tracking information including, but not limited to: Visit Reports, Regulatory Documents, Site Contact Lists, Team Contact Lists, Vendor Lists, and Budget Disbursements Manages and tracks Investigational Product supplies for study centers; receives and prepares requests, ships and returns Investigational Product supplies Prepares, ships and manages inventory of study related supplies Performs all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions, and appropriate industry and Good Clinical Practices standards Gathers investigator and site information (addresses, phone numbers, fax numbers, personnel names and email addresses, etc.) Assists in preparing materials for investigator meetings, workshops, and study manuals Creates meeting agenda/minute templates and provides drafts of meeting minutes Communicates effectively with members of the GBT and vendor project teams Other tasks or responsibilities as assigned Qualifications: The qualified candidate will have a Bachelor and/or advanced degree in nursing, biological sciences or related field, or equivalent combination of relevant experience, education or training and previous CTA experience She/he will have the following: Attention to detail Excellent organizational skills Effective communication and interpersonal skills Ability to efficiently perform multiple tasks and manage changing priorities Ability to identify and solve logistical problems Ability to work effectively on a diverse team Ability to read and understand regulatory documents and Standard Operating Procedures Demonstrate proficiency in Microsoft Word, PowerPoint and Excel Take direction well Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Global Blood Therapeutics San Francisco, CA, USA
Jan 25, 2020
Full time
EXECUTIVE ASSISTANT, BUSINESS AND STRATEGY Job Summary: Reporting to the Chief Business & Strategy Officer, the Executive Assistant provides administrative support to the Chief Business Officer and her organization, including Corporate Development and Government Affairs & Policy, and helps ensure the smooth operations of the Executive Office. The successful candidate will be extremely well organized, an excellent communicator, capable of effectively managing complex schedules, skilled at interfacing with key external audiences including the Board of Directors and external partners, have excellent judgment and discretion, and works collaboratively with other members of the GBT administrative team to coordinate various activities. Over time, the Executive Assistant will be able to anticipate many of the needs of the team and will be proactive in the execution of those needs. Essential Duties and Responsibilities: Provide administrative support to the CBO, Corporate Development, and Government Affairs & Policy teams Manage and maintain calendars, arrange travel, travel expenses, organize meetings Maintain budget tracking, vendor set-up including generating POs and finalizing agreements Organize confidential meetings, including travel arrangements, for prospective external partners Manage meeting calendars for key conferences Create and edit PowerPoint presentations Handle special projects as requested (such as GBT Women's Group social and speaker events) Support departmental communications and communications within the Corporate Development and Government Affairs & Policy groups, as well as with internal and external clients Qualifications: At least ten years of experience in the biopharmaceutical industry, including experience supporting a C-level executive Highly-developed interpersonal skills including communication and listening skills, attitude, exhibiting a professional, proactive, optimistic, and calm demeanor Excellent verbal and written skills and attention to detail Ability to juggle multiple priorities and manage complicated calendars across multiple executives and external personnel Demonstrated judgment and discretion with confidential company information Proactive approach to business needs and requirements Ability to work independently and be flexible, adjusting priorities and tasks in real time to support the objectives of the departments Successful experience in fast-paced, high growth environment High proficiency with various applications including: PowerPoint, Word, Excel, Outlook, as well as Concur, vendor/PO software programs Manage domestic and international meeting and travel arrangements that may often require changes and prepare expense reports Previous experience supporting Corporate/Business Development or Government Affairs/Policy functions a plus Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Global Blood Therapeutics Chicago, IL, USA
Jan 22, 2020
Full time
MEDICAL SCIENCE LIAISON - Midwest - IL, MO, IN Position Summary: The Medical Science Liaison (MSL) will participate in the strategic development and tactical execution of plans to engage scientific thought leaders and act as a conduit for providing accurate and updated clinical, scientific and medical information to Health Care Professionals and other members of the scientific community. The MSL will provide non-promotional scientific, educational, and research support for the Global Blood Therapeutics (GBT) product portfolio, in particular for Voxelotor, for the treatment of sickle cell disease (SCD). The MSL will provide field-based medical support for GBT's clinical research programs, registries and facilitation of the investigator sponsored trials process. The MSL will provide requested, clinical and scientific information to KOLs, HCP's academia, payer, government organizations, community-based patient organizations and other members of the healthcare community in compliance with all relevant company policies. This is a home-office based position and can be based out of Illinois, Missouri, or Indiana. Essential Duties and Responsibilities: Through appropriate scientific exchange, builds and maintains professional relationship with external stakeholders to expand GBT's research, advisory and education partnership opportunities Develop clinical knowledge expertise in the SCD treatment landscape including current treatment strategies, and new therapeutic developments Participate and sometimes lead the development and execution of medical strategies to identify, key SCD experts, investigators and institutions strategic to research and development efforts Develop and ensure alignment in medical education activities for healthcare professionals through MSL-delivered presentations, participation in medical meetings, and other appropriate venues to enhance product and disease state knowledge Collaborate with the GBT clinical team, medical monitors and CRA's to coordinate and optimize educational and research support for sites/investigators participating in GBT's clinical trials Respond to unsolicited requests regarding interest in investigator sponsored studies (ISS), and supporting ISS submissions through appropriate internal review and approval processes Ensure alignment on content of effective clinical presentations provided to internal and external audiences, ensuring presentations are tailored to meet the specific needs of the audience (appropriate response to unsolicited requests) Ensure efficient information exchange between MSL colleagues in the field and office-based clinical, medical affairs, and drug safety team members, so that key clinical, safety and research issues are identified and communicated to and from industry leaders and the appropriate GBT departments to help shape company research, development, and strategies for investigational and commercialized products Identify educational needs within the medical community around the SCD state management Maintain clinical expertise through comprehensive education including attendance at relevant symposium, scientific workshops, and review of key journals; and where applicable participation in required internal training, and presentations Adhere to all regulatory and compliance guidelines and company policies in all aspects of scientific dissemination of information, including responses to unsolicited requests for medical information Serve as a liaison between HCP's and KOL's and GBT Medical Affairs Participate in KOL planning Mentors other MSL team members Assist and augment in the training and development of Medical colleagues, regional field-based MSL's and Sales teams Support development of appropriate responses to unique inquires as required in the areas of scientific evidence and medical education, etc. Qualifications: An advanced degree in life sciences (MD, PharmD, PhD or equivalent) is preferred with a minimum of 5 years of experience as a MSL with 3 years as a field MSL or comparable role Has an established and demonstrated track record of effective and influential oral presentations with the healthcare profession Has excellent leadership, management and negotiation skills. The ability to work in a fast-paced and dynamic environment Ability to influence and work effectively across functions and operate in a matrix environment Demonstrated 3 year's minimum of therapeutic research or substantive patient care experience is required Launch experience is highly preferred Prior experience in the rare disease and/or hematology is highly preferred Ability to travel 60-70% No relocation required (home-office based) Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Global Blood Therapeutics San Francisco, CA, USA
Jan 17, 2020
Full time
EXECUTIVE DIRECTOR, GLOBAL COMMERCIAL PLANNING Position Summary: Global Blood Therapeutics is seeking a seasoned leader to oversee our Global Commercial Planning function. Reporting to the Chief Commercial Officer, the ED of Global Commercial Planning sets the commercial vision and strategy for GBT's portfolio and develops the global go to market strategy for commercial stage assets. This individual is responsible for setting global brand strategy, working with regions to ensure launch readiness and building business cases for new market entry. The Global Commercial Planning team is a highly matrixed function that partners closely with HQ Commercial Functions, Regional Leads, Medical Affairs, Corporate Development, Government Affairs and Advocacy as other core global functions on the Product Development Team (Clinical, Regulatory, Research and Manufacturing) in the execution of the global commercial strategy for GBT's product portfolio. Essential Duties and Responsibilities: Provide commercial input to the Product Development Teams to ensure development plans and regulatory strategies maximize the lifetime value of GBT's clinical stage assets. Oversee intelligence gathering on key competitors and ensure the organization understands and anticipates the impact of their actions Partner with Medical Affairs and Clinical Development to drive a data generation plan that meets key regional needs to describe the disease burden and target product claims Partner with regional leads to create the global brand vision including the positioning, core messaging and country launch sequencing strategy that will be used by the regions to develop local brand plans and optimize the global success of clinical stage assets. Build global market access framework including development of global economic value story, pricing governance and access goals Work closely with Medical Affairs, Government Affairs & Advocacy to identify key market development goals and ensure timely execution Partner closely with corporate development to identify distribution partners and optimal footprint in MENA and Americas geographies where GBT will not have a direct presence and assist in alliance management efforts in those geographies Ensure new projects are global in nature and scalable as appropriate Engender a spirit of cross-regional sharing of best practices ensure integration and geographic alignment of core commercial strategies and timely execution of key launch activities. Work closely with corporate affairs to develop an asset acquisition strategy and build commercial business cases for new opportunities Recruit, retain, develop and inspire a talented team Strong analytical skills and the ability to develop and inform forecast assumptions Manage market research projects to ex-US regions to inform strategies Qualifications: The successful candidate must possess a minimum of 10 years experience in the pharmaceutical/biopharmaceutical industry. He/She will be a well-rounded commercial executive across product/brand/franchise life cycles. Candidates must have the proven ability to provide strategic leadership, vision and direction within a fast moving, challenging and energetic corporate environment. It is critical that candidates understand how to leverage and optimize partnerships with other functions throughout the organization. He/She should have global commercial experience, ideally having managed global market access during a new product launch in specialty/orphan therapeutic area. Specific qualifications include: Bachelors' degree, MBA/MPH/advanced science degree preferred, and a minimum of 10 years of progressive commercial leadership experience in Pharmaceutical/Biotechnology industry or consulting arena, including some combination of marketing, market access, market analytics and/or new product planning Global Marketing or Global Market Access experience Self-starter who effectively influences across boundaries, builds effective relationships inside and outside of own team and who proactively drives projects and tasks towards successful completion Entrepreneurial spirit and the ability to develop innovative ideas and solutions Results oriented and excellent analytic and communication skills Ability to manage complexity and ambiguity in a highly matrixed environment Ability to work across multiple geographies, time zones, and cultures Excellent leadership skills and the ability to inspire, coach, and motivate Prior experience in rare diseases and prior experience in a small, rapidly growing company are both preferred Travel is estimated to be 35%, including international Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Global Blood Therapeutics San Francisco, CA, USA
Jan 16, 2020
Full time
SENIOR ADMINISTRATIVE ASSISTANT, FIELD SALES TEAM Position Summary: Reports to VP, Sales; Provides administrative and operational support to the Field Sales team (and other field organizations) as outlined and/or needed. The ideal candidate will thrive in a service and support role and is highly detail-oriented. Essential Duties and Responsibilities: Provides encompassing administrative support to the VP Sales (and their direct reports) Proactively manages and maintains VP Sales calendar; arranges travel, travel expenses, organize meetings at their request, etc. Provides administrative and operational support to Field Sales organization Be the first point of contact for the Field Sales organization (field sales leaders and field sales professionals) Must be able to prioritize and manage multiple projects simultaneously including: Be the Field Sales organization's first point of contact for training/trouble-shooting any in-house support needs Coordinate on-boarding/off-boarding of field sales employees (work cross-functionally with HR, IT, Sales Ops, Training, etc.) to ensure employees receive (or return) their equipment and access Manages Field Team/Rep Rosters (that feed into internal systems); coordinates with internal partners to maintain Audits, processes and triage exhibit, sponsorship/display applications; communications payments back to the field organization Supports meetings/events lead and training lead as needed in the planning of field sales off-cycle meetings, regional based and training meetings Provides meetings operational/admin support to training lead as it relates to executing HQ-based training events Will eventually become point of contact for, and maintaining/processing credentialing requests Handles confidential material with discretion and professionalism Handles special projects as requested Qualifications: A minimum of 8 years of administrative experience (biotech preferred) in increasing positions of responsibility Strong knowledge of MS Office; Excel, Word, PowerPoint, Outlook Excellent verbal and written skills and attention to detail Ability to juggle multiple priorities and manage complicated calendars across multiple executives and external personnel Ability to work independently and be flexible, adjusting priorities and tasks in real time to support the objectives of the departments Successful experience in fast-paced, high growth environment Proven ability to handle confidential material with discretion and professionalism Must have excellent customer-service orientation, high degree of professionalism, and be a strong team player Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Global Blood Therapeutics San Francisco, CA, USA
Jan 15, 2020
Full time
SENIOR LOGISTICS SPECIALISTS Job Summary: This position will coordinate day to day activities necessary to ensure timely shipments of Global Blood Therapeutics (GBT) products, from starting materials to finished products, including lab samples. This position will coordinate global shipment and logistics, ensuring all required documentation is in place and all activities are efficiently coordinated. The Sr. Logistics Specialist will also support inventory management strategies, and the development and maintenance of shipping profiles. Essential Duties and Responsibilities: Maintain transportation structure for GBT's products. Develop and maintain GBT product shipment profiles, evaluate proper shipment lanes Coordinate and manage distribution networks and logistics and transportation activities for all material types - raw and starting materials, drug substance, drug product and finished product Coordinates freight movement from origin to destination including all follow through to delivery (place orders, appointment confirmations, tracking as needed) Coordinate global Import/Export process and related documentation with Contract Manufacturing Organizations (CMO's), couriers and customs brokers Assist in identifying and implementing continuous improvement of shipping processes and procedures, implement key process indicators as required to ensure and effective and compliant GMP supply chain Main point of contact for external warehouse operations, coordinating receiving and shipping transactions Oversee transportation couriers, collect and analyze global freight spend and communicate trends to management Coordinate availability of documentation including Pro-forma and Customs invoices, packing lists Effective cross-functional collaborator and communicator. Interface with GBT's Technical Operations, Analytical Development, Quality Assurance and others as required Assist in selecting proper transportation carriers, including contracts and Power of Attorney approval, drafting of procedures and continued oversight of approved transportation vendors Support Supply Chain department in material planning and inventory control activities Additional projects and responsibilities as required Qualifications: Bachelors in Operations, Materials Management, or a related field or equivalent experience in the field CPIM, DOT, IATA DGR certifications a plus Minimum 3-5 years in a supply chain, warehouse/ logistics role within the pharmaceutical industry, with hands-on experience in managing all aspects of transportation and delivery for domestic and international locations Must have experience with customs management and FDA cargo inspections Cold Chain logistics experience Experience with global distribution and logistics, hazardous material transport, carrier selection and management, temperature-controlled transportation requirements Basic knowledge of current Good Manufacturing Practices and Good Distribution Practices (GDP) compliance Ability to develop relationships and interact effectively with all levels of customer and supplier organizations, demonstrating an excellent customer mindset in interfacing with internal departments and suppliers Possesses good organizational skills, a strong attention to detail, and an ability to prioritize tasks within a busy environment Ability to work under time constraints and meet deadlines Proficient in Microsoft Office suite utilization Excellent written and verbal communication skills Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Global Blood Therapeutics San Francisco, CA, USA
Jan 10, 2020
Full time
SENIOR DIRECTOR, MEDICAL WRITING Position Summary: Reporting to the VP, Clinical Operations, the Senior Director, Medical Writing will direct and provide technical and operational writing support across GBT programs and manage external and/or internal medical writing staff. The Medical Writer will be responsible for working cross-functionally with internal customers and stakeholders to develop, implement and maintain a standardized document development process for clinical and regulatory documents. This includes, but is not limited to: directing, authoring, editing and providing input to clinical documents, documents required for regulatory submissions to US and other global health authorities, presentations, posters, publications and regulatory fulfillment. He/she may also author/edit and/or direct the development of pre-clinical documents. The Medical Writer will be responsible for managing external resources in support of the Medical Writing requirements. Preference would be for someone to be on-site with flexibility to work remotely. Essential Duties and Responsibilities: Works with the clinical and regulatory teams to prepare clinical documents (including Clinical Study Reports (CSRs), protocols, protocol amendments, Briefing Documents, Investigator Brochures (IBs), safety updates, Clinical Summaries of Safety and Efficacy, Clinical Overview) and pre-clinical study protocols and reports under strict timelines Provides leadership in planning and completing key regulatory submissions to US and global health authorities (including but not limited to: New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), Investigational New Drug (IND) submissions, and annual reports) Ensures key messages are clear and consistent within and across documents. Contributes strategically and scientifically at the project and/or study team level. Provides editorial or review support (or coordinates external resources) for other types of documents, such as abstracts, manuscripts, posters, and presentations for scientific meetings and journals Collaborates with cross-functional team members (e.g., PK, Toxicology, Research, Clinical Development, Regulatory Affairs, Biometrics, Quality, CMC etc.) to ensure accurate and timely completion/delivery of high-quality, scientifically-justified documents Demonstrated ability to communicate and write clearly, concisely, and effectively. Aptitude for compilation, analysis, and presentation of data Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members Ensures a consistent style of document presentation to maintain quality and ease of review, and adherence to company standards Procures and manages external medical writing resources (e.g., Contract Research Organizations (CRO), document quality reviewers, freelance medical writers, etc.) Contributes to the development and standardization of templates and related processes, including updating, revising and developing relevant SOPs and internal best practices and processes for critical document development Qualifications: Advanced degree (e.g. PhD, PharmD, MD) with 8+ years in medical writing experience in pharmaceutical industry At least 8 years of experience in a medical writing role, including participation in submissions to the US FDA (NDA, BLA) and EMA (MAA) Demonstrated experience in the preparation of protocols, study reports, investigator brochures, safety updates, and Regulatory documents, including IND and NDA submissions Demonstrated ability to incorporate pre-clinical data into clinical and regulatory documents Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects Excellent attention to detail, including fact checking, logical flow, parallelism, formatting, and document structure Well-organized: ability to prioritize tasks, to work simultaneously on multiple projects, and to complete high quality documents according to tight timelines. Demonstrated internal and external stakeholder management and project management experience Demonstrated ability to represent and advocate for Medical Writing and influence without direct authority Manages, coaches and mentors' direct reports. Assists in the day-to-day operational activities and other assignments as needed and specified by management Broad knowledge of EMA/ICH guidelines and FDA guidance beyond those pertaining to specific regulatory documents Proficiency with Microsoft Office and use of electronic document templates Experience analyzing references for scientific appropriateness and regulatory ramifications of reference selection; familiarity with PubMed and/or other reference-gathering search tools Proficiency with Adobe Acrobat, and Electronic Common Technical Document (eCTD) templates Familiarity with GCP, applicable regulatory requirements and guidance documents (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives, ICH guidelines) company SOPs and internal style guides, researches, authors, and edits Travel - 20% Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Global Blood Therapeutics San Francisco, CA, USA
Jan 10, 2020
Full time
RESEARCH ASSOCIATE - PROTEIN BIOCHEMISTRY AND CELL BIOLOGY Position Summary: We are looking for a Research Associate with expertise in protein purification, protein biochemistry and cell biology. This position will support our drug discovery effort, by generating key research tools and reagents and executing biochemical and cell-based assays to support identification and optimization of drug-like molecules. The successful candidate will join a multi-disciplinary team focused on elucidating the in-vitro properties of proteins involved in human hemoglobinopathies. The ideal candidate must be highly motivated, detail-oriented, work autonomously with a variety of techniques, and comfortable presenting results to cross-functional teams. Essential Duties and Responsibilities: Perform in vitro studies for early drug discovery projects Execute cell-based and biochemical screening assays to evaluate drug candidates Develop and optimize novel assays Independently plan, execute and analyze experiments Qualifications: BS/MS in biochemistry, molecular biology or equivalent discipline with 1 to 3 years of technical experience Expression of proteins in mammalian/bacteria/yeast systems for research and early stage screening work Hands-on laboratory experience with molecular cloning, construct design and optimization Extensive experience with purification of recombinant protein and characterization of protein complexes using chromatography methods Mammalian cell line maintenance, generation of stable cell line, and transfection Demonstrated ability to approach solutions by systematic troubleshooting, creative/critical thinking, high degree of accuracy and attention to details Interest in translational biology aspects of small molecule drug development projects is desirable Excellent organizational and communication skills (oral, written, presentation) Ability to work independently as well as contribute actively to an integrated team Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a multidisciplinary team Values-based work ethics consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.