Medical Director Early Clinical Development, Oncology

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Job description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Medical Director, Early Development Oncology

Live

What you will do

Lets do this. Lets change the world. In this vital role you will be part of advancing the largest early Oncology pipeline in our history spanning several innovative technology platforms Bispecific T Cell Engagers (BiTEs), Cellular Therapies, Bispecific Antibodies, Small Molecules, and Oncolytic Viruses 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.

To support that effort, the Oncology Early Development Group is looking for a Medical Director. The Medical Director will lead early phase clinical development of oncology compounds from first-in-human studies through proof of concept. They 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 Amgens Product Strategy Teams through their role as an Early Development Leader (EDL).

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

Responsibilities:

• Serve as an internal clinical expert in translational and clinical oncology.
• Serve as medical monitor for clinical trials and assist in resolving major issues that may affect the studies.
• Present information internally and externally, anticipating and proactively managing problems across a broad spectrum of cross-functional teams.
• Coordinate clinical approaches to operational issues and assign monitoring and safety reporting resources.
• 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.
• Will be the primary Medical Sciences contact for basic scientists studying hematologic and solid tumor malignancies as well as for clinical research scientists leading all aspects of later clinical development.
• Evaluate external opportunities for partnering or licensing new oncology assets

Win

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

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

Preferred Qualifications:

• Strong basic science or clinical research 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
• Previous experience in late-stage oncology clinical trials and regulatory filings
• Demonstrated expertise in conducting translational and/or clinical oncology research
• Expertise in Spotfire or other data analysis tools
• Knowledge of GCP, EMA, and FDA policies
• Expertise in authoring clinical sections of CTA or INDs

Thrive

What you can expect of us

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

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising 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 including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

Application deadline

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.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided 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.

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