Manager, HCV Global Medical Affairs
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.Making an impact on a global scale
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Job DescriptionManager, HCV Global Medical Affairs
Gilead Sciences is a biopharmaceutical company that discovers, develops, and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe, Asia, and Australia. We have the following exciting opportunity to be based in our Foster City location or remotely.
Reporting to the Executive Director of Global HCV Medical Affairs in Foster City, this role is responsible for managing, maintaining, and executing the HCV data generation and communication efforts for HCV (primarily Epclusa and Vosevi), in collaboration with Gilead affiliates worldwide.Responsibilities:Late phase research programs Coordinate medical review committees (IRC & GRC) including proposal review, study activation, status tracking, publication planning, and manuscript review
Project management of late-phase research programs, including meeting organization and effective communication regarding the plans, execution, and completion of actions steps from the meeting outputs
Organize data collection regarding ongoing Liver studies and status reporting with updated information from across TAs
Assist with Gilead-supported clinical studies and provide scientific expertise into study concepts; participate in building study synopses, protocols, and other study documents; and liaise with affiliates and investigators
Maintain regular contact with investigators to track study progress and publication deliverables
Collaborate with Scientific Communications colleagues regarding planned congress presentations and publications; and provide medical and scientific support at key scientific meetings involving HCV e.g., AASLD, EASL, and APASL
Produce and review abstracts, manuscripts, posters, and oral presentations for Gilead-supported, investigator-sponsored, and collaborative studies
Collaborate with Medical Information to review and update global response documents and custom response documents, and serve as an information resource to Gilead colleagues regarding HCV
Serve as global medical affairs reviewer for promotional material for HCV
Provide input and support to the Global Medical Plan of Action, and monitor performance against HCV team annual goals and objectives
Develop effective working relationships with internal and external customers, including Clinical Research, Biometrics, Commercial and Marketing, Contracts/Finance, Virology, Pharmacology, Legal, Medical Scientists and other Gilead Medical Affairs colleagues, Medical Directors/Medical Managers in affiliate offices, investigators, research organizations
Other activities, as assigned, to support HCV/Liver Disease Medical Affairs
Knowledge, Experience, and Skills:
M.D., D.O., Ph.D. (biological or pharmaceutical sciences), PharmD, NP, PA, or MPH
Pharmaceutical industry or clinical research experience in Medical Affairs, Clinical Development, or Research; clinical trials management, scientific expertise desirable
Experience in hepatology, fibrosis, virology, or clinical virology is highly desirable
Experience in clinical patient care is highly desirable
Excellent written, verbal and interpersonal, relationship-building, and negotiating communication skills
Experience in developing effective abstracts, manuscripts, posters, and slides and presenting at scientific meetings
Excellent organizational skills to support project planning across multiple activities, anticipate and prioritize workload
Excellent analytical skills demonstrated ability to identify and understand complex issues and problems and identify and query key findings from study data and publications
Excellent teamwork skills. Organized; attention to detail and ability to meet timelines in a fast-paced environment
Ability to suggest solutions for issues encountered with clinical studies and other projects in the area of responsibility
Ability to work with a level of autonomy and independence
Must be fully cognizant and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; thorough knowledge of FDA regulations, ICH guidelines, and GCPs governing the conduct of clinical trials
Ability to work around international time zones and ability to travel to domestic and international conferences, for which occasional weekend travel is required
International experience and/or foreign language skills are an advantage
Examples of operational excellence
Organized and systematic approach to prioritization
Process oriented to achieve business objectives
Resilient profile with the ability to deliver results in an ambiguous environment
Ability to engage and manage multiple stakeholders to achieve objectives
Curiosity and learning agility
Gilead Core Values
- Integrity (Doing What's Right)
- Teamwork (Working Together)
- Excellence (Being Your Best)
- Accountability (Taking Personal Responsibility)
- Inclusion (Encouraging Diversity)
The salary range for this position is: $139,145.00 - $180,070.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
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* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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