Executive Director, Inflammation

Career Category

Clinical Development

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission—to serve patients—has driven our status as one of the world’s preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.

Executive Director, Clinical Development, Inflammation

Live

What you will do

Let’s do this. Let’s change the world. As an Executive Director, you will play an important role in 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 inflammation disease clinical drug development activities from discovery research through first in human, POC and Phase 3 or Phase 4 studies. 

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

This role will include global development leadership of one or more assets within the portfolio and require people management activities.  The position must 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.

Responsibilities

• Serve as the global development leader for a product team with an enterprise mindset

• Develop the clinical strategy for the product including indication 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 in 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 documentations, 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

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What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Executive Medical Director we seek is an experienced leader with the following qualifications.

Basic Qualifications

• MD or DO from an accredited medical school AND

• Five (5) years of industry or academic research AND

• Six (6) years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Quali