European Medical Lead

Category: Medical Affairs
Job ID: R-69215
Employment Type: Full time
Location: Switzerland – Rotkreuz
Posted Date: March 18, 2019

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. Every year, Amgen is included on numerous best employers’ lists worldwide, as we understand that our success rests on attracting and retaining the best talent.

Our European Hub based in Rotkreuz, Switzerland is comprised of highly qualified professionals from a variety of cultural backgrounds, whose efforts are primarily centered on marketing our products in the region.

We are currently seeking an European Medical Lead for our Oncology therapeutic area. The successful candidate will mainly focus on providing medical leadership over the Multiple Myeloma EU Franchise which includes commercialized products as well as pipeline products. This includes oversight, development, inputs into the product and portfolio strategy, support to clinical development activities as well as team and matrix management.

Additional responsibilities include:

  • Participates in the development of Global and regional strategy, disease area strategy and product lifecycle and tactics with the Global Medical Affairs Lead/Global Development Lead and the EU Therapeutic Area Head
  • Leads regional study team and works with Global Development Organization to support execution of study protocols for Amgen Sponsored Trial’s (AST’s)
  • Supports regulatory and ethics approvals for regional AST’s
  • Provides clinical input to and review of Global Development documents
  • Supports affiliates in protocol development of Local AST’s and approves Local AST’s prior to PRC submission
  • Provides interpretation of clinical study data
  • Interacts with regional OLs, professional societies and study groups for strategic discussions and scientific exchange
  • Identify evidence gaps (clinical, observational, economics in partnership with Global Health Economics), reviews regional and Local ISS proposals
  • Reviews scientific literature
  • Design and initiate database analyses to support clinical and commercial activities
  • Organizes and/or conducts Medical Advisory Boards Meetings/Expert Panels and participates in Investigator Meetings
  • Provides clinical input and support for publications, training, symposia, RML support, congress activities and other scientific affairs activities
  • Provides clinical content expertise for documents and participates in meetings in support of regulatory, safety, health economic and reimbursement interactions in the region
  • Provides clinical input, reviews and participates in approval of materials used by scientific affairs or the commercial organisation in the region
  • Supports external partnerships
  • Coach and mentor other team members

Qualifications:

  • Medical education in relevant therapeutic area
  • Minimum 5 or more years of clinical development experience, 4 years of which should be from a pharmaceutical or biotechnology company
  • Experience with clinical study management and conduct
  • Broad and formal leadership experience
  • Knowledge of pharmaceutical product development, product lifecycle and commercialization process with advanced understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Regulatory, and Medical Affairs
  • Therapeutic area knowledge
  • Expertise in regional medical practice and healthcare systems
  • Network of clinical contacts in therapeutic area
  • Finance and budgeting experience

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