Medical Senior Director – Early Clinical Development, Oncology

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, 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.

Medical Senior Director – Early Development, Oncology

What you will do

Let’s do this. Let’s change the world. In this vital role you will lead early phase clinical development of oncology compounds from first-in-human studies through proof of concept. They effectively define, design, and implement early phase clinical and translational projects as the initial strategy for drug development. They typically serve as clinical project leaders for one or more of Amgen’s Product Strategy Teams through their role as an Early Development Leader (EDL).

These experts represent Early Development internally and externally, contributing intellectual insight into experimental design and data analysis. They provide subject matter expertise in clinical and translational science as well as biology and the treatment of cancer.

Responsibilities:

• Leader of the Evidence Generation Team (EGT) and accountable for its deliverables, namely defining the early clinical development plan and overseeing its execution.
• Serve as an internal clinical expert in translational and clinical oncology and is capable of effective clinical representation on early preclinical assets communicating critical clinical needs, attributes and impact on molecule pre-development.
• Provide mentorship to junior medical directors and medical science directors in early clinical development.
• Evaluate external opportunities for partnering or licensing new oncology assets as a clinical representative to business development projects.
• Present information internally and externally, anticipating and proactively managing problems across a broad spectrum of cross-functional teams.
• Effectively liaise with Global Development Leads (GDL) to help develop global strategy for oncology assets transitioning to late stage.
• Identify and coordinate clinical approaches to operational issues and assign monitoring and safety reporting resources.
• Responsible for the medical monitoring plan of various oncology assets and in some cases accountable for oversight of multiple studies.
• Strong cross-functional collaborator with Research, Regulatory, Precision Medicine and other functions.
• Provide guidance and assistance in the identification and management of oncology phase 1 collaborators, consultants, and/or Clinical Research Organizations (CROs) in the completion of key projects.
• Ensure appropriate training, recruitment, and development requirements for matrix team resources.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Basic Qualifications:

MD or DO degree from an accredited medical school

AND

5 years of clinical research and/or basic science research experience

And

5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

• Strong basic science background in academia or industry
• Prior experience authoring, monitoring, analyzing, and presenting oncology clinical trials
• Effective presentation and communication abilities (both written and oral)
• Ability to anticipate problems and find creative solutions
• In-depth understanding of the scientific method and clinical applications based on medical, scientific, and practical rationale including working knowledge of biomarker methods and clinical imaging endpoints
• A record of high-quality peer-reviewed publications
• Experience functioning as a medical expert in a complex matrixed environment
• Previous experience in early phase development and/or biomarker work
• Demonstrated experti