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Asset Lead Medical Dir, Gout

7+ years
Not Disclosed
10 Nov. 26, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Asset Lead Medical Director

How Might You Defy Imagination?

At Amgen, our shared mission—to serve patients—drives all that we do. By joining us, you will be part of a global collaboration that delivers innovative therapies to millions of patients worldwide. It’s time to make a real impact in a career you can be proud of.


What You Will Do

As the Asset Lead Medical Director, you will play a pivotal role in shaping and executing U.S. medical strategies for our products, including supporting launches and lifecycle management. This position will involve collaborating with global teams and cross-functional stakeholders to ensure that Amgen’s products make the greatest impact on patient care.

Key Responsibilities:

  • Lead the development and execution of the U.S. product medical strategy, aligning with global strategies and ensuring seamless execution through the U.S. Medical Plan.
  • Identify scientific evidence gaps and work with the global team to create an evidence generation strategy.
  • Engage with external key stakeholders to support scientific exchange, often in partnership with other functions.
  • Provide medical input into label and regulatory interactions, ensuring alignment with global strategy and clinical data.
  • Implement Medical governance for respective products, collaborating with GRAAS for safety and risk management.
  • Ensure compliance and provide strategic oversight in clinical trial conduct.
  • Support appropriate medical content for external interactions, including congresses, publications, and communications.
  • Collaborate closely with cross-functional teams to align on product lifecycle management and support for launch and commercialization.

What We Expect of You

We seek a dynamic and experienced leader who is ready to drive innovation. The ideal candidate will have the following qualifications:

Basic Qualifications:

  • Doctorate degree and 4 years of relevant experience, OR
  • Master’s degree and 7 years of relevant experience, OR
  • Bachelor’s degree and 9 years of relevant experience.

Preferred Qualifications:

  • Medical Degree (MD) with at least 6 years of medical affairs or clinical development experience in a relevant therapeutic area, at least 1 year from a pharmaceutical or biotechnology company.
  • 4 years of managerial experience, with direct responsibility for managing teams, projects, or resources.
  • Accredited fellowship in rheumatology, Allergy and Immunology (Board certified or board eligible).
  • Proven expertise in rheumatological diseases and experience in a complex matrix environment.
  • Knowledge of pharmaceutical product development, clinical trials, product lifecycle, and commercialization processes.
  • Strong experience in scientific exchange and clinical research, with the ability to lead scientific discussions.
  • Familiarity with clinical trial design, biostatistics, and Good Clinical Practices (GCP).
  • Experience with regulatory requirements, medical affairs, and healthcare ecosystems.
  • Strong leadership abilities, including the ability to motivate and manage cross-functional teams.

What You Can Expect of Us

At Amgen, we are committed to fostering your growth and well-being. In addition to a competitive salary, our Total Rewards Plan offers:

  • A comprehensive employee benefits package with health, dental, vision, life, and disability insurance.
  • Retirement and savings plans with generous company contributions.
  • Discretionary annual bonuses and stock-based long-term incentives.
  • Award-winning time-off plans, including bi-annual company-wide shutdowns.
  • Flexible work models, including remote work arrangements where possible.
  • Career development and learning opportunities to support your growth.