Amgen, South San Francisco, CA is seeking a highly motivated and team-oriented candidate for the position of Principal Scientist in the Clinical Pharmacology Modeling & Simulation Department within Medical Sciences. The individual will be responsible for the planning and execution of clinical pharmacology strategies in support of small and large molecule drug development, registration, and/or post-marketing activities.
Doctorate degree and 3 years of scientific experience
Master's degree and 6 years of scientific experience
Bachelor's degree and 8 years of scientific experience
PhD in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Biostatistics, Life Sciences or with equivalent professional degrees (e.g. MD, PharmD) with 5+ years of experience in the Biotechnology/Pharmaceutical Industry or post-doctoral training.
Experience as a Clinical Pharmacology functional representative on product development teams.
Experience 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.
Experience with PK and PK/PD strategies, data analysis, interpretation, and reporting for small molecule and/or protein therapeutics.
Experience in population PK/PD modeling and simulations.
Experience in authoring regulatory documents, knowledge in global regulatory requirements and guidance, and interaction with global health authorities.
Demonstrated ability to work with flexibility, efficiency and diplomacy both individually and as part of a team effort.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
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.
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.
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