Director, Clinical Pharmacology, Modeling and Simulation
About The Position
Amgen is seeking a Director for its Clinical Pharmacology, Modeling & Simulation Department in South San Francisco, California. The Director will lead development and implementation of clinical pharmacology, modeling, and simulation strategies for Amgen’s pipeline across therapeutic modalities. The role serves as a subject matter expert in clinical pharmacology and drug development, designing strategic plans integrated with clinical development plans and applying Model-Informed Drug Development and quantitative clinical pharmacology principles to support new drug development. The Director represents the department on global cross-functional drug development teams and applies quantitative pharmacokinetic/pharmacodynamic approaches throughout early- and late-stage programs. The work includes Population PK/PD, PBPK, and QSP modeling to support safe and effective dosing regimens for patient subpopulations and optimal drug development. The role also involves leading the design and implementation of clinical pharmacology and biopharmaceutic studies and applying their results to development and regulatory submissions.
Requirements
- Doctorate degree and 4 years of Clinical Pharmacology and Modeling & Simulation experience; or master’s degree and 8 years of such experience; or bachelor’s degree and 10 years of such experience.
- At least 4 years of experience directly managing people and/or leadership experience leading teams, projects, or programs, or directing resource allocation. This experience may overlap with the required technical experience.
Nice To Haves
- PhD in Pharmacokinetics, Pharmaceutical Sciences, or Pharmacology, or an equivalent professional degree such as MD or PharmD.
- 8 or more years of Clinical Pharmacology, Modeling & Simulation experience in the biotechnology or pharmaceutical industry.
- Established track record designing strategic clinical pharmacology, modeling, and simulation plans supporting drug development across modalities.
- Experience leading clinical pharmacology and biopharmaceutic studies, including bioequivalence, biocomparability, drug-drug interaction, special population, ethnic sensitivity, ADME, and pediatric studies, and integrating results into regulatory filings and product labels.
- Established track record interacting with global health authorities and authoring regulatory documents, with knowledge of global regulatory requirements and guidance.
- Hands-on experience using quantitative PK/PD approaches, particularly Population PK/PD and PBPK modeling, to inform clinical study designs for drug-drug interaction, special population, ethnic sensitivity, pediatric, and biopharmaceutic studies.
- Expert knowledge of commonly used software for PBPK modeling.
- Established track record of Model Based Drug Development.
Responsibilities
- Develop and implement clinical pharmacology, modeling, and simulation strategies for drug development across modalities.
- Design strategic clinical pharmacology, modeling, and simulation plans integrated with clinical development plans.
- Design clinical pharmacology and biopharmaceutic studies.
- Apply Model-Informed Drug Development strategies and quantitative clinical pharmacology principles to guide drug development.
- Represent the Clinical Pharmacology, Modeling & Simulation Department on global cross-functional drug development teams.
- Apply quantitative PK/PD approaches and clinical pharmacology strategies across early- and late-stage development programs.
- Apply Population PK/PD, PBPK, and QSP modeling to support safe and effective dosing regimens for patient subpopulations.
- Lead the design and implementation of clinical pharmacology and biopharmaceutic studies, and integrate results into regulatory filings and product labels.
Benefits
- Health and welfare plans for staff and eligible dependents.
- Retirement and savings plan with company contributions.
- Group medical, dental, and vision coverage.
- Life and disability insurance.
- Flexible spending accounts.
- Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Flexible work models where possible.
- Career development opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Director
