Senior Director of Quantitative Pharmacology Modeling & Simulation
Amgen
Summary
This position in Quantitative Pharmacology Modeling & Simulation will lead the strategy, development, and application of quantitative modeling and simulation capabilities that inform early drug-development decisions through prediction of human pharmacokinetics and pharmacodynamics. This senior leader will build and scale a high-performing team that integrates quantitative data to reduce uncertainty and improve confidence in candidate selection and human-dose projections. The role combines deep scientific and technical expertise with strong organizational leadership and partners closely with Precision Medicine, Toxicology, Operations, and Clinical Pharmacology to ensure a seamless transition from preclinical modeling to clinical development.
Job description
Key Responsibilities
- Define and execute the strategy, roadmap, investment priorities, governance, and operating model for model-informed drug design
- Lead, develop, and retain a team with expertise in mechanistic and empirical modeling, PBPK, PK/PD, and quantitative systems pharmacology to inform human-dose prediction
- Establish a consistent modeling framework for investigational new drug–enabling activities
- Lead quantitative assessment of candidate differentiation, projected human exposure, dose and regimen feasibility, therapeutic index, and first-in-human starting-dose recommendations
- Drive development and application of PBPK, allometric scaling, mechanistic PK/PD, QSP, and related approaches appropriate to the asset, therapeutic area, and available evidence
- Collaborate across Research and Development to ensure models reflect high-quality, fit-for-purpose data and relevant product attributes
- Establish model-development, qualification, validation, documentation, reproducibility, and lifecycle-management standards
- Participate in integrated program teams as a subject matter expert to clearly communicate quantitative evidence, uncertainty, assumptions, tradeoffs, and recommended actions
- Build external partnerships with academic institutions, technology providers, and scientific thought leaders to advance modeling capabilities
- Manage the function's budget, workforce plan, external vendors, and technology investments
Basic Qualifications
- Doctorate degree in Pharmaceutical Sciences, Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, Biomedical Engineering, Applied Mathematics, or a related quantitative discipline and 5 years of relevant pharmaceutical or biotechnology experience in translational modeling, DMPK modeling, PBPK, PK/PD, QSP, or related quantitative drug-development disciplines
- OR Master's degree in a related quantitative discipline and 9 years of relevant pharmaceutical or biotechnology experience
- OR Bachelor's degree in a related quantitative discipline and 11 years of relevant pharmaceutical or biotechnology experience
- At least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
Preferred Qualifications
- Advanced degree in a related quantitative discipline; PhD required
- 15+ years of relevant pharmaceutical or biotechnology experience in translational modeling, DMPK modeling, PBPK, PK/PD, QSP, or related quantitative drug-development disciplines
- 5+ years of progressive leadership experience managing technical teams, functions, or major cross-functional programs
- Demonstrated expertise applying quantitative models to preclinical-to-clinical translation, human PK prediction, and first-in-human dose selection
- Proven ability to shape program strategy and influence senior scientific and business stakeholders
- Excellent written and verbal communication skills
- Experience with PBPK platforms, QSP, physiologically based absorption modeling, allometric scaling, mechanistic PK/PD, or virtual-population approaches
- Experience across multiple therapeutic areas and modalities
- Experience establishing or scaling a translational modeling capability
- Strong record of scientific thought leadership through publications, patents, presentations, or industry participation
- Experience working in a matrixed environment
Requirements
- Doctorate degree in Pharmaceutical Sciences, Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, Biomedical Engineering, Applied Mathematics, or related quantitative discipline with 5 years relevant pharma/biotech experience, OR
- Master's degree in related quantitative discipline with 9 years relevant pharma/biotech experience, OR
- Bachelor's degree in related quantitative discipline with 11 years relevant pharma/biotech experience
- Relevant experience in translational modeling, DMPK modeling, PBPK, PK/PD, QSP, or related quantitative drug-development disciplines
- At least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing allocation of resources
- PhD required (preferred qualification)
- 15+ years relevant pharmaceutical or biotechnology experience (preferred)
- 5+ years progressive leadership experience managing technical teams, functions, or major cross-functional programs (preferred)
- Demonstrated expertise in preclinical-to-clinical translation, human PK prediction, and first-in-human dose selection (preferred)
- Proven ability to shape program strategy and influence senior stakeholders (preferred)
- Excellent written and verbal communication skills (preferred)
- Experience with PBPK platforms, QSP, physiologically based absorption modeling, allometric scaling, mechanistic PK/PD, or virtual-population approaches (preferred)
- Experience across multiple therapeutic areas and modalities (preferred)
- Experience establishing or scaling a translational modeling capability (preferred)
- Strong record of scientific thought leadership (preferred)
- Experience working in a matrixed environment (preferred)
Benefits
- Retirement & Savings Plan
- Medical, Dental & Vision
- Life & Disability Insurance
- Flexible Spending Accounts
- Discretionary Annual Bonus
- Stock-Based Long-Term Incentives
- Time-Off Plans
- Flexible Work Models
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.