HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Medical Director – Early Development- Hematology/Oncology

Live

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, 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.

To support that effort, the Oncology Early Development Group is looking for a Medical Director.

In this vital role they 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 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,

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Medical Director plays a critical role in the medical monitoring of a clinical study ensuring safety to patients. The Medical Director may also provide expert input or lead functional process improvement initiatives and provide contributions to cross-asset, cross-tumor working groups.

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

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 annual base salary range for this opportunity in the U.S. is $246,380. – $294,987.

In addition to the base salary, 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

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

If you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancers, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to 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.