Global Medical Affairs Director - Primary Biliary Cholangitis

Global Medical Affairs Director - Primary Biliary Cholangitis

Gilead

Uxbridge, United Kingdom

This role is a leadership position within the Medical Affairs organization that reports to the Senior Director of Global Medical Affairs, Primary Biliary Cholangitis. This is a global role that involves the development and execution of global strategies for Primary Biliary Cholangitis. 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.

The key functions of this role will be to collaborate with internal and external stakeholders involved in Primary Biliary Cholangitis including the Foster City Medical Affairs team, Scientific Communications, 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.

Specific Job Requirements

  • Demonstrate deep subject matter expertise with regard to Primary Biliary Cholangitis, as well as Gilead pipeline and competitive products;
  • Demonstrate ability to rapidly establish credible knowledge base for other fibrotic and liver conditions, including but not limited to PBC, viral hepatitis, and NASH. Develop strategies to address unmet medical needs within the patient populations affected;
  • Prepare presentation materials and present scientific data at internal meetings and external Advisory Boards;
  • Serve as an information resource and trainer to Gilead colleagues, including the Medical Scientists, including medical educational activities, grants and investigator-sponsored and collaborative studies;
  • Support data generation activities through:
    • Critical review of global ISRs, Ph 3b and Ph4 study proposals;
    • Manage PBC 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.
  • 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 leadership and support at key scientific meetings involving PBC;
  • Lead the development and execution of the Global Medical Affairs Plan of Action and work with affiliates on the development and execution of country level and regional medical affairs plans;
  • Serve on Independent Medical Education (IMED) Committee to review and give medical perspective on IMED proposals;
  • Other activities, as assigned, to support Liver Global Medical Affairs.

Essential 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 travel up to 10-15% at times;
  • 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.

Knowledge, Experience & Skills

  • M.D., D.O., PhD (biological or pharmaceutical sciences), PharmD with extensive experience in hepatology, gastroenterology or inflammation;
  • Clinical experience with direct patient care and the management of Chronic Liver Disease required;
  • Minimum of 5 years of experience in Medical Affairs and/or Clinical Research including Phase IIIb and IV studies; clinical trials management, medical monitoring and scientific expertise.

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