Executive Director, Clinical Development, General Medicine

Career Category

Clinical Development

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, Obesity and Rare Disease– we reach millions of patients each year.

As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based.

If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Executive Director, Clinical Development, General Medicine

What you will do

Let’s do this. Let’s change the world. In this vital role as an Executive Director, you will play an important role in scientific strategy and planning and execution for all aspects of clinical drug development across Amgen’s clinical programs.

This Executive Director within Clinical Development will be involved with the full scope of the General Medicine disease clinical drug development activities from the design and execution of Phase 2 through Phase 4 studies.

They will serve as the principal representative for global development within the General Medicine therapeutic area to a range of audiences, including executive leadership, development partners, and global regulatory agencies.

The General Medicine portfolio encompasses a broad array of therapeutic areas that include cardiovascular disease and prevention, renal disease, neurological, endocrine disease including bone diseases, among others.  It does not include oncology and inflammatory diseases.

This role will include global development leadership of one or more assets within the portfolio and require people management activities. The position will work closely with all members of the cross-functional product team to apply full clinical knowledge to successfully advance clinical programs, as well as the overall product strategy.

The Executive Director will report into the Vice President, Global Clinical Development General Medicine.

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 adequate oversight and mentoring of R&D personnel to design clinical development plans and protocols spanning all phases of development per indication in collaboration with product team members, key opinion leaders (KOLs) and CROs that are aligned with the target product profile

• Provide adequate oversight into the development of the primary and secondary endpoints for efficacy and safety as well as contribute to the biostatistics analysis plan, and clinical study reports (CSRs) along with biostatistics and other R&D colleagues

• 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

• Provide adequate oversight and mentoring of clinical development colleagues in co-authoring and reviewing clinical sections of regulatory documents

• Lead the evidence generation strategy as well as contribute to content of individual publications, abstracts, and presentations

• Maintain up-to-date knowledge of scientific and clinical published literature

• Interact with KOLs to assure implementation of latest clinical thinking and guidelines into the integrated product development plan

• Serve as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, and consultants

• Provide input/review 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 activ