Director, Clinical Pharmacology

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. Join us.

Director, Clinical PharmacologyLive

What you will do

Lets do this. Lets change the world. Biotechnology opened the door to new types of medicines based on natures own building blocks. No company has done more to advance this revolution than Amgen & the companys broad toolkit of drug modalities just got larger https://www.amgenscience.com/features/the-shape-of-drugs-to-come/

The Clinical Pharmacology, Modeling & Simulation Department at Amgen is seeking a Director, Clinical Pharmacology for its San Francisco, CA location. The Director, Clinical Pharmacology will be an established leader in the field of clinical pharmacology and a subject matter expert of clinical pharmacology. The Director of Clinical Pharmacology will be responsible for the development and implementation of integrated Clinical Pharmacology and Pharmacometric strategies for cutting-edge novel modalities including mono-clonal antibodies, Bi-specific antibodies, Bi-specific T-cell engagers, oncolytic viruses, in addition to small molecules. The Director of Clinical Pharmacology will apply Model-Based Drug Development and principles of quantitative clinical pharmacology to optimize dose/dosing regimen for target patient populations/sub-populations in target indication(s) while ensuring optimal drug development and clinical study design efficiencies, lead the design and execution of clinical pharmacology and biopharmaceutic strategy and clinical pharmacology and biopharmaceutic studies in support of drug development plans. The Director of Clinical Pharmacology will represent the Clinical Pharmacology, Modeling & Simulation Department at the global drug development teams for one or more Oncology programs and will report to the Clinical Pharmacology Therapeutic Area Leader.

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 go-getter with these qualifications.

Basic Qualifications:

Doctorate degree (PhD and/or MD and or PharmD) and 5 years Clinical Pharmacology and Pharmacometrics experience from the Biotechnology/Pharmaceutical Industry

Or

Masters degree and 7 years Clinical Pharmacology and Pharmacometrics experience from the Biotechnology/Pharmaceutical Industry

Or

Bachelors degree and 9 years Clinical Pharmacology and Pharmacometrics experience from the Biotechnology/Pharmaceutical Industry

Preferred Qualifications:

• PhD (in Pharmacokinetics or Pharmaceutics or Pharmaceutical Sciences or equivalent professional degrees e.g., MD, PharmD) with 10+ years of experience in Clinical Pharmacology and Pharmacometrics in the Biotechnology/Pharmaceutical Industry.
• Established track-record of NDA/BLA, sNDA/sBLA global filings for therapeutic proteins and small molecules as lead clinical pharmacologist and extensive experience of interactions with global health authorities, authoring regulatory documents, knowledge of global regulatory requirements and guidance.
• Established track-record of experience in designing and executing strategic integrated clinical pharmacology & modeling & simulation plans in support of development of both small molecule and therapeutic proteins.
• Hands-on experience in quantitative clinical pharmacology approaches including Population Pharmacokinetics and Population Pharmacokinetic/Pharmacodynamic modeling and simulation and Physiologically Based Pharmacokinetic modeling and simulation.
• Experience in leading the design and execution of clinical pharmacology and biopharmaceutic studies including bioequivalence, bio-comparability, drug-drug interaction, special population, ethnic sensitivity, ADME and pediatric studies and integrating results into regulatory filings, and product labels.
• Established track-record of Model Based Drug Development

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.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now

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

Join Us

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 cancer, 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.