Executive Director, Clinical Development - Rare Disease (Newbury Park)

Executive Director, Clinical Development, Rare Disease

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 rare 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 rare disease 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 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.

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 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.

They will also embody the Amgen leadership attributes which are :

What You Can Expect Of Us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being.

From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

The annual base salary range for this opportunity in the U.S. is $342,744 - $399,424.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work / life balance, and career development opportunities that may include :

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.