Executive Medical Director, Early Development, Oncology

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 Medical Director Early Development, Oncology

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What you will do

Let’s do this. Let’s change the world.

Amgen is advancing the largest early Oncology pipeline in our history spanning several innovative technology platforms – Bispecific T Cell Engagers (BiTE®s), Bispecific Antibodies, and Small Molecules – across many targets and more than a dozen tumor types.  We need collaborative and innovative world-class talent to ensure these molecules become medicines and reach their full potential while helping patients.

In this vital role, the Executive Medical Director will serve as an Early Development Oncology Portfolio lead for key assets in the Amgen portfolio and be responsible to represent Oncology Clinical Development. They will serve as the principal representative for an early development portfolio to a range of audiences, including executive leadership, development partners, and global regulatory agencies. 

They will develop and translate oncology development program strategies into the design and implementation of clinical studies that can be executed without compromising scientific rigor. The Executive Medical Director will report into the Vice President, Early Development.

Responsibilities

• Develop an Oncology Early Development team in collaboration with Early Development Oncology Therapeutic Area Head

• Represent Amgen at joint development committees, at academic institutions as well as with global regulatory agencies

• Ensure the best way to develop and prosecute an early development portfolio

• Drive the timely execution of multiple assets and studies within their early development portfolio

• Ensure strategy and execution, and partner closely with Product Team Lead (PTL), study management, biostatistics, data management, and research colleagues

• Partner closely with regulatory leaders to support regulatory interactions and develop regulatory strategies

• Keep major stakeholders and other senior management updated as the portfolio evolves and matures

• Guide their team to think broadly as they create innovative portfolio development strategy options.  Ensure all avenues and options have been explored and weighted before final recommendations sent to review by senior leadership

• Oversee activities related to planning for studies including execution and oversight of study outlines and Protocols for early development clinical studies

• Mentor, coach, and supervise the performance of direct reports to build highly skilled, diverse, and inclusive teams, leading and motivating staff in a complex, multi-functional matrix environment

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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 Qualifications

• MD, PhD, MBBS plus accredited residency in relevant sub-specialty, board certified or equivalent

• Subspecialty board eligibility/certification or equivalent in Oncology or Hematology

• Eight (8) or more years of clinical research experience and/or basic science research experience

• Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)

• Ten (10) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities

• Proven success record in how to conceptualize, design, conduct, and analyze early development clinical trials

• Ability to anticipate problems and find creative solutions

• In-depth understanding of the scientific method a