Clinical Development Medical Director, Early Development Oncology

Amgen · Remote (Remote US)

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About the role

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

What you will do

Let’s do this. Let’s change the world. In this vital role, you will lead the early phase clinical development of compounds from first-in-human studies through proof-of-concept. You will collaborate on teams to support the design and delivery of early phase clinical trials. Through this role, the Clinical Medical Director will support protocol development, study start up, data review, monitoring and analysis activities.

Responsibilities

Contribute to the design and implementation of the early clinical development strategy for oncology therapeutic candidates

Contribute to the preparation of clinical development plans, clinical study protocols, informed consents, Investigator Brochures, and Ethics Committee and regulatory agency submissions

Review and evaluate clinical study safety, efficacy, pharmacodynamic and pharmacokinetic data

Contribute to the strategy and use of clinical biomarkers to facilitate drug development

Actively collaborate with Amgen Precision Medicine, Research, Late Development, Regulatory, Safety and Commercial colleagues

Contribute to the evaluation of external licensing or partnering opportunities within the oncology therapeutic areas

Collaborate with external experts to provide biomedical expertise and strategic guidance to oncology early development teams

What we expect of you

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

Basic Qualifications

MD or DO degree from an accredited medical school AND

2 years of industry or academic clinical research/drug development experience

Residency training in Oncology and relevant subspecialty

Experience in basic research and/or clinical trial methodology

3+ years of relevant drug development experience in the pharmaceutical industry and/or academia, preferably in early stage clinical trials

Experience collaborating with pharmaceutical sponsors

Experience in designing, monitoring and implementing clinical trials and interpreting trial results

Demonstrated leadership qualities; capable of conducting studies as part of a team

Experience within a matrix environment, contributes to decision-making and reaching alignment in order to meet challenging timelines

Continued in Amgen’s original posting ↗.

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