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 BioSpace. Amgen is focused on serving patients living with serious illnesses. The company operates in oncology, rare disease, general medicine, and inflammation, and aims to transform the lives of patients while advancing science. What You Will Do In this vital role, you will contribute to scientific strategy, planning, and execution across Amgen’s clinical programs. You will be involved with the full scope of rare disease clinical development activities from design through execution of Phase 2 to Phase 4 studies. You will serve as the principal representative for global development within the rare disease therapeutic area to executive leadership, development partners, and regulatory agencies. The role includes global development leadership of one or more assets and may involve people management. You will work closely with cross-functional teams to apply clinical knowledge to advance programs and the overall product strategy. You will report to the Vice President, Global Clinical Development. 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 trials Provide oversight and mentoring of R&D personnel to design clinical development plans and protocols spanning all phases per indication, in collaboration with product team members, key opinion leaders (KOLs) and CROs Oversee development of primary and secondary endpoints for efficacy and safety; contribute to the biostatistics analysis plan and CSRs with biostatistics and other R&D colleagues Drive clinical development components in writing and interpreting CSRs and oversee filing and registration activities Review, interpret, and present clinical data to internal and external stakeholders Provide oversight and mentoring for co-authoring and reviewing regulatory clinical sections Lead the 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 development plan Serve as 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 provide clinical support for investigator and steering committee meetings Participate in due diligence and business development activities as needed Always operate within Compliance Guidelines Provide medical monitoring oversight for clinical trials as required What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. The candidate we seek is an experienced leader with the following qualifications. 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, programs, or directing the allocation of resources Preferred Qualifications PhD, MBBS plus accredited residency in relevant sub-specialty; board certified or equivalent Ten (10) or more years in biopharmaceutical sponsored clinical research Biopharmaceutical experience as a medical monitor and clinical lead across therapeutic areas Understanding of biostatistics, regulatory, clinical pharmacology, pre-clinical toxicology approaches Knowledge of GCP, FDA regulations and guidelines, and international regulatory requirements Strong ability to present ideas and document complex medical concepts Ability to analyze and interpret complex datasets Initiative and drive for innovation Demonstrates Amgen leadership attributes: Inspire, Accelerate, Integrate, Adapt. Thrive – What You Can Expect Of Us Amgen supports professional and personal growth and well-being. Benefits and a collaborative culture are part of the experience. The base salary range for this opportunity in the U.S. is $343,334 - $403,728. Comprehensive benefits including retirement and savings plans, medical/dental/vision, life and disability insurance, and flexible spending accounts Discretionary annual bonus or sales-based incentive plan where applicable Stock-based long-term incentives Awards, time-off programs, and flexible work models where possible Equal Opportunity Amgen is an Equal Opportunity employer and will consider all qualified applicants 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. Amgen provides reasonable accommodation to participate in the job application or interview process. Please contact us to request accommodation. There is no application deadline; applications are accepted until a suitable candidate is selected. Seniority level Executive Employment type Full-time Job function Research, Analyst, and Information Technology #J-18808-Ljbffr

Created: 2025-10-06