Medical 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 Director – Early Clinical 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 compounds from first-in-human studies through proof of concept for solid tumors and blood cancers. They define, design, and deliver 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 Clinical Development, Oncology 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.

• Responsible for the oversight and medical monitoring of early phase clinical studies (First-in-Human, Phase 1-2), and ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance FDA, EMEA, ICH and GCP guidelines as well as Amgen SOPs regarding safety.
• Significant contributor to the development of the strategy for assigned compound(s)/programs and working with team members to develop a compelling business case for governance approval.
• Work cross functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents.
• Accountable for the integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval.
• Responsible for providing clinical input into & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results

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 preference for individuals with clinical training in oncology; subspecialty board eligibility/certification in Oncology and/or Hematology
• PhD or additional advanced degrees desirable
• Industry or academic experience in early-phase oncology drug development
• Strong communication & presentation skills to clearly communicate scientific concepts /data to leadership committees both internally or externally (both written and oral)
• Experience with designing, monitoring, and implementing oncology clinical trials and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements
• Understanding of conducting study data readout activities, including data cleaning, data base lock, data extract, producing outputs of data
• Experience drafting high level submission documents for regulatory submissions including authoring clinical regulatory responses for health regulatory interactions
• Serving as a contributing author to scientific publications and data presentations at scientific conferences
• Experience in clinical data analysis such as Spotfire or other data analysis tools

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 expected annual salary range for this role in the U.S. (excluding Puert