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Executive Medical Director, Obesity

Amgen
Full-time
Remote friendly (United States)
United States
Medical Affairs

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Role Summary

Executive Medical Director, Obesity. Oversees a team of physician-scientists that support evidence generation for obesity and obesity-related conditions, and reports to the Vice President, Obesity.

Responsibilities

  • Provide clinical/scientific knowledge into the development, design, delivery and communication of the global evidence generation plan for multiple metabolic assets.
  • Support (and lead when requested) cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program
  • Participate and provide clinical input into safety and regulatory interactions
  • Interpret and communicate clinical trial data
  • Oversee the authoring of clinical study reports, publications and regulatory submissions
  • Develop relationships with key opinion leaders and make scientific presentations at advisory boards, key scientific meetings and external committee meetings as delegated by the Vice President
  • Provide clinical content input to materials to be used in Scientific Affairs as well as the Commercial Organization
  • Contribute to TPP (target product profile) and Global Product Safety (GPS) development
  • Create development options and present to Global Dev Review Committee (GDRC), Therapeutic Area Governance (TAG), and Portfolio Governance
  • Interact with TA leadership and extended team to develop strategic options
  • Interact and collaborate with CfDA, CfOR, CPMS, etc., to bring innovative later development options
  • Provide clinical and scientific input to business development interactions including due diligence processes

Qualifications

  • MD or DO degree from an accredited medical school
  • Five years of industry or academic research
  • Six years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications

  • Five or more years of clinical research experience in the biopharmaceutical industry in obesity or obesity-related conditions
  • Eight or more years of clinical research and/or basic science research with clinical teaching and patient care activities
  • Previous experience in regulatory interactions
  • Strong clinical development experience in endocrinology and relevant sub-specialty
  • Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes
  • Experience developing study concepts for clinical development and trial designs with cross-functional input
  • Knowledge of GCP, FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements
  • Leadership experience in a complex matrix environment
  • Ability to present and document complex medical concepts in written and oral form
  • Strong interpersonal and problem-solving skills with sound judgment

Skills

  • Clinical and scientific communication
  • Cross-functional collaboration
  • Regulatory and safety liaison
  • Strategic development planning
  • Medical leadership and mentorship

Education

  • MD or DO degree from an accredited medical school
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