Executive Director, Clinical Development - Rare Disease

Executive Director, Clinical Development - Rare Disease

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Amgen is dedicated to serving patients living with serious illnesses. Join a team that researches, manufactures, and delivers innovative medicines worldwide.

As Executive Director in Clinical Development, you will lead scientific strategy and planning for all aspects of clinical drug development across Amgen’s rare disease programs. You will design and execute Phase 2–Phase 4 studies, serve as the principal global development representative, and lead one or more assets within the portfolio while managing people and collaborating cross‑functionally.

• Serve as the global development leader for a product team with an enterprise mindset
• Develop the clinical strategy for the product, including indications and sequencing
• Partner with clinical operations to deliver the studies
• Manage clinical development medical and/or scientific directors working on various clinical trials for the product
• Provide oversight and mentoring of R&D personnel to design clinical development plans and protocols spanning all phases of development per indication
• Oversee the development of primary and secondary endpoints, contribute to biostatistics analysis plans, and produce clinical study reports (CSRs)
• Drive clinical development components in the writing and data interpretation of CSRs and oversee filing and registration activities
• Review, interpret, and present clinical data to internal and external stakeholders
• Mentor clinical development colleagues in reviewing clinical sections of regulatory documents
• Lead evidence generation strategy and contribute to publications, abstracts, and presentations
• Maintain up‑to‑date knowledge of scientific and clinical literature
• Interact with KOLs to incorporate latest clinical thinking into the product development plan
• Serve as a medical and technical resource for clinical issues raised by collaborators, investigators, and consultants
• Provide input on study start‑up documentation (e.g., CRF design)
• Attend and support investigator and steering committee meetings
• Participate in due diligence and business development activities as needed
• Operate within compliance guidelines
• Provide medical monitoring oversight for clinical trials as required

• MD or DO from an accredited medical school
• Five (5) years of industry or academic research
• Six (6) years of managerial experience directly managing people and/or leading teams, projects, or programs

• PhD, MBBS with accredited residency in a relevant sub‑specialty, board certified or equivalent
• Ten (10) or more years in biopharmaceutical‑sponsored clinical research
• Experience as a medical monitor and clinical lead across therapeutic areas
• Solid understanding of biostatistics, regulatory affairs, clinical pharmacology, and pre‑clinical toxicology
• Knowledge of GCP, FDA regulations, and international regulatory requirements
• Strong oral and written communication skills for presenting complex medical/clinical concepts
• Ability to analyze and interpret complex datasets
• Initiative in meeting goals and driving innovation

• Inspire:
  Create a connected, inclusive, and inspiring work environment that empowers talent to thrive
• Accelerate:
  Enable speed that matches the urgency of patient needs by encouraging progress over perfection
• Integrate:
  Connect the dots to amplify collective power and drive results for patients, staff, and shareholders
• Adapt:
  Lead through change by adapting to an ever‑changing environment and defining a clear course of action to deliver results

The annual base salary range for this opportunity in the U.S. is $343,334 – $403,728. The total rewards plan includes:

• Comprehensive employee benefits package (retirement and savings plan, group medical, dental, vision, life and disability insurance, flexible spending accounts)
• Discretionary annual bonus program or sales‑based incentive plan for field sales representatives
• Stock‑based long‑term incentives
• Award‑winning time‑off plans and bi‑annual…