Medical Director - US Medical Affairs - Inflammation

Employer
Amgen
Location
Thousand Oaks, California
Posted
May 24, 2018
Ref
R-55944
Required Education
Bachelors Degree
Position Type
Full time

The US Medical Director for Enbrel in the Inflammation therapeutic area supports the implementation of US Medical strategies, including US launch and lifecycle management.

The US MD is responsible for:

  • Supporting the development and execution of US product medical strategy, via the US Medical Plan, including launch support and lifecycle management, in collaboration with Product Team/Portfolio Governance and alignment with Global strategy
  • Supporting definition of scientific evidence gaps, development of local evidence generation strategy in coordination with Global
  • Supporting clinical trial conduct
  • Participating in engagement of external key stakeholders (often in partnership with other functions)
  • Participating in development of data communication strategy (including congress)
  • Supports Medical input into label and regulatory interactions, in alignment and with deep understanding of global strategy and program clinical trial data
  • Supports implementation of Medical governance for respective product, which includes:
    • Safety and pharmacovigilance as a key and effective partner with GRAAS
    • Clinical trial conduct
    • US risk management/minimization in collaboration with GRAAS
    • Subject matter appropriateness (medical/scientific) of external interactions (e.g. copy review, multichannel, congresses, 1-1 interactions, etc.)
  • Ensuring appropriate medical support of compliance

Basic Qualifications

MD or DO degree from an accredited medical school

AND

2 years of clinical research experience and/or basic science research

Preferred Qualifications

  • Accredited fellowship in Rheumatology, board certified or board eligible
  • 2 years of medical affairs experience or clinical development experience with deep understanding of medical affairs, 1 years of which should be from a pharmaceutical or biotechnology company
  • Clinical or research experience in Gastroenterology
  • Broad and formal leadership experience
  • US and/or Global experience
  • Experience with clinical study management and conduct
  • Familiarity with US health care compliance considerations
  • Experience with opinion leader interactions
  • Experience with integrated delivery networks, accountable care organizations, and payers

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.