Amgen Principal Scientist - Clinical Pharmacology in South San Francisco, California
Amgen is a values based organization with a powerful sense of shared purpose toward our mission: to serve patients. At our San Francisco facilities, we provide the capabilities, resources, and rewards of a global enterprise, while maintaining the entrepreneurialism and verve that marked our early days as a biotechnology pioneer. We encourage our team members to have fulfilling and meaningful careers through challenging assignments, career development, and valuable opportunities such as this.
Biotechnology opened the door to new types of medicines based on nature's own building blocks. No company has done more to advance this revolution than Amgen & the company's broad toolkit of drug modalities just got larger www.amgenscience.com/the-shape-of-drugs-to-come. The Clinical Pharmacology, Modeling & Simulation Department within Medical Sciences at Amgen is seeking a Principal Scientist.
The Principal Scientist of Clinical Pharmacology will be responsible for the development and implementation of the Clinical Pharmacology and Modeling Simulation strategies for cutting-edge novel modalities including Bi-specific T-cell engagers, antibody-drug-conjugates, CAR-T cells, oncolytic virus & listeria based immunotherapies in addition to small molecule & mono-clonal antibodies. The Principal Scientist will be a member of cross-functional global drug development teams as the Clinical Pharmacology, Modeling & Simulation department representative & will be Subject Matter Expert who will apply cutting-edge Quantitative Pharmacokinetic/Pharmacodynamic (PK/PD) approaches to ensure development of safe & effective dosing regimens for various patient sub-populations & also ensure optimal drug development. The Principal Scientist will also be responsible for designing integrated Clinical Pharmacology Modeling & Simulation plans & designing, planning and execution of clinical pharmacology studies in support of these plans.
Doctorate degree and 3 years of Pharmaceutical or Biotech experience
Master's degree and 6 years of Pharmaceutical or Biotech experience
Bachelor's degree and 8 years of Pharmaceutical or Biotech experience
PhD (in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology) or (MD or PharmD)
8+ years of experience as Clinical Pharmacology Modeling & Simulation functional representative on product development teams in the Biotechnology/Pharmaceutical Industry.
Experience in designing strategic integrated clinical pharmacology & modeling simulation plans in support of development of small molecule and/or protein therapeutics.
Experience in leading the design and execution of clinical pharmacology studies including bioequivalence, 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. Hands-on experience in population PK/PD & PBPK modeling and simulation.
Experience with PK and PK/PD strategies, data analysis, interpretation, and reporting of PK and PK/PD data from clinical studies.
Established track record of interaction with global health authorities, authoring regulatory documents, knowledge of global regulatory requirements and guidances.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
A Fortune 150 company operating in nearly 100 countries around the world, we invest in highly skilled, dedicated and collaborative individuals who are ready to contribute to our mission in meaningful ways and make a difference in the lives of our patients. That's why, as a member of our cross functional, cross discipline team, we provide you with valuable opportunities to broaden your experience and maximize your potential. Focused on the industry's most compelling scientific discoveries and housed within industry leading facilities within the heart of the world's leading biotechnology hub, our colleagues are growing our pipeline through groundbreaking innovations. We believe in rewarding those who do rewarding work and are committed to providing careers that can help turn the tide of serious, life interrupting illnesses.
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.
Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.