Global Medical Affairs Manager (Fremont, CA)

Description:

Manager, Global Medical Affairs (Hepatitis B)

Summary:

This contractor role is within the LIFE (Liver, Inflammation, Fibrosis and Established Products) Medical Affairs organization and reports to the Executive Director of Global Medical Affairs, Hepatitis C. This is a global role that involves the development and execution of global strategies for products in the LIFE franchise. The individual must be a self-starter and able to lead the development of global strategic activities as well as develop and execute them on a tactical level. As part of the global liver diseases medical affairs group, there will also be an opportunity to work closely with Hepatitis B.

The key functions of this role will be to collaborate with internal and external stakeholders including the Foster City Medical Affairs team, Scientific Publications, Medical Affairs Research, Marketing, Global Commercial Product Strategy, Value and Market Access, Clinical Research, Public Affairs, Government Affairs, Contracts/Finance, Pharmacology, Virology and Legal on both the global and regional levels.

Requirements:

• Demonstrate deep subject matter expertise with regard to LIFE products and competitive products.
• Prepare presentation materials for internal and external meetings, including Advisory Boards.
• Serve as an information resource and trainer to colleagues, including the Medical Scientists, including medical educational activities, grants and investigator-sponsored/collaborative studies
• Support data generation activities through:
• Critical review of global ISRs, Ph 3b and Ph4 study proposals
• Manage HBV Phase IV portfolio including liaising with key cross-functional partners such as clinical operations and local affiliates
• Review abstracts and/or manuscripts that result from the phase IV program
• Support the management and documentation of phase IV study status
• Serve as Medical Affairs therapeutic area expert on Global Publications and Scientific Message Platform committees and other support for Scientific Communications
• Provide medical and scientific coverage and support at key scientific meetings
• Support project leads in the execution and tracking of their projects (eg. Global Medical Affairs Plan of Action, publications, reviews of medical and commercial assets, etc.)
• Oversee medical and scientific review of promotional materials for GRC and MRC
• Other activities, as assigned, to support LIFE Medical Affairs

Skills:

• Excellent written, verbal and interpersonal, relationship-building and negotiating communication skills
• Excellent organizational skills to support project planning across multiple activities, anticipate and prioritize workload
• Excellent teamwork skills. Organized; attention to detail and able to meet timelines in a fast-paced environment
• Excellent analytical and problem solving skills, demonstrated ability to identify and understand complex issues and problems and identify and query key findings from study data and publications
• Experience in public health or Internal Medicine (general or subspecialty) is highly desirable, in addition to clinical patient care.
• Experience in developing effective abstracts, manuscripts, posters and slides and presenting at scientific meetings
• 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
• Must be able to work with autonomy and independence
• Ability to work around international time zones and ability to travel to and participate in domestic and international conferences which will include occasional weekend travel is required
• Ability to work in a global environment which will require participation in meetings outside of standard work hours and on the weekends to accommodate time zone differences

Qualifications:

• Bachelor’s degree a minimum, but M.D., D.O., PhD (biological or pharmaceutical sciences), or PharmD preferred. Prior experience in hepatology, infectious diseases, virology or clinical virology a plus.
• Preferred experience in Medical Affairs and/or Clinical Research including Phase IIIb and IV studies; clinical trials management, medical monitoring and scientific expertise.