Executive Director, Clinical Development - Rare Disease

Executive Director, Clinical Development - Rare Disease Join to apply for the Executive Director, Clinical Development - Rare Disease role at Amgen . Amgen is dedicated to serving patients living with serious illnesses. Join a team that researches, manufactures, and delivers innovative medicines worldwide. What You Will Do 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. Responsibilities 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 What We Expect Of You Basic Qualifications 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 Preferred Qualifications 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 Leadership Attributes 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 What You Can Expect Of Us 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 company‑wide shutdowns Flexible work models, including remote work arrangements where possible Amgen fosters an inclusive environment of diverse, ethical, committed, and highly accomplished people who respect each other and live the Amgen values to advance science for patients worldwide. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. #J-18808-Ljbffr BioSpace