Director, AI/ML MIDD Oncology Clinical Pharmacology, Modeling and Simulation
GSK
August 20, 2026
Remote friendly (Waltham, MA)
United States
Clinical Research and Development
Director, AI/ML MIDD Oncology Clinical Pharmacology, Modeling and Simulation
Responsibilities:
- Define and execute model-based development strategies for oncology projects
- Plan, conduct, and report exposure-response analysis, simulation-based trial design and dose selection, and population PK modeling
- Apply drug-disease modeling, longitudinal exposure-response analysis, model-based meta-analysis, quantitative systems pharmacology, and AI/ML-informed analyses to improve data use and trial efficiency
- Present and defend model-based approaches to governance boards and regulatory agencies
- Contribute to clinical program design, trial protocols, analysis plans, study reports, and regulatory submissions
- Write/review clinical pharmacology components of regulatory documents and responses for optimal labeling approval
- Implement best practices and incorporate internal/external lessons learned to advance CPMS contributions
- Interact with line/middle management and external contacts strategically and tactically
- Promote model-informed drug discovery/development via collaboration, publications, and conference presentations
- Work across matrix teams to innovate methodologies and design efficiencies
Basic Qualifications (required):
- PhD in Quantitative Clinical Pharmacology and Pharmacometrics (or relevant Life Sciences) with industry/academic modeling/simulation experience; PharmD or Master’s with 4 additional years may be considered
- 5+ years in mechanistic PKPD and longitudinal disease modeling; proficiency in NONMEM or R
- 3+ years planning/performing/reporting clinical data analyses per industry/regulatory standards
- Expertise in applying AI/ML in clinical pharmacology and pharmacometrics
Preferred Qualifications:
- Knowledge of/ability to quickly learn cancer mechanisms, endpoints, progression, and treatments
- Up-to-date with and proposes new modeling approaches
- Strong collaboration, communication, and accountability; sound judgment in complex situations
- Experience designing/analysing/interpreting/reporting clinical pharmacology studies
- Passion for quantitative clinical pharmacology; desire to innovate
- Oncology R&D experience; work with senior stakeholders; strong presentation skills
- Track record of implementing Model-Informed Drug Development (MIDD) approaches
Benefits (if part of posting):
- Annual bonus; share-based long-term incentive eligibility; health care/insurance, retirement, paid holidays/vacation, and paid caregiver/parental and medical leave (details by location)
Skills/Keywords:
- Drug development/discovery; molecular modeling; pharmacokinetics/pharmacodynamics; pharmacometrics; model-informed drug development; study design; target validation; pharmaceutical/regulatory compliance; pharmacovigilance.
Responsibilities:
- Define and execute model-based development strategies for oncology projects
- Plan, conduct, and report exposure-response analysis, simulation-based trial design and dose selection, and population PK modeling
- Apply drug-disease modeling, longitudinal exposure-response analysis, model-based meta-analysis, quantitative systems pharmacology, and AI/ML-informed analyses to improve data use and trial efficiency
- Present and defend model-based approaches to governance boards and regulatory agencies
- Contribute to clinical program design, trial protocols, analysis plans, study reports, and regulatory submissions
- Write/review clinical pharmacology components of regulatory documents and responses for optimal labeling approval
- Implement best practices and incorporate internal/external lessons learned to advance CPMS contributions
- Interact with line/middle management and external contacts strategically and tactically
- Promote model-informed drug discovery/development via collaboration, publications, and conference presentations
- Work across matrix teams to innovate methodologies and design efficiencies
Basic Qualifications (required):
- PhD in Quantitative Clinical Pharmacology and Pharmacometrics (or relevant Life Sciences) with industry/academic modeling/simulation experience; PharmD or Master’s with 4 additional years may be considered
- 5+ years in mechanistic PKPD and longitudinal disease modeling; proficiency in NONMEM or R
- 3+ years planning/performing/reporting clinical data analyses per industry/regulatory standards
- Expertise in applying AI/ML in clinical pharmacology and pharmacometrics
Preferred Qualifications:
- Knowledge of/ability to quickly learn cancer mechanisms, endpoints, progression, and treatments
- Up-to-date with and proposes new modeling approaches
- Strong collaboration, communication, and accountability; sound judgment in complex situations
- Experience designing/analysing/interpreting/reporting clinical pharmacology studies
- Passion for quantitative clinical pharmacology; desire to innovate
- Oncology R&D experience; work with senior stakeholders; strong presentation skills
- Track record of implementing Model-Informed Drug Development (MIDD) approaches
Benefits (if part of posting):
- Annual bonus; share-based long-term incentive eligibility; health care/insurance, retirement, paid holidays/vacation, and paid caregiver/parental and medical leave (details by location)
Skills/Keywords:
- Drug development/discovery; molecular modeling; pharmacokinetics/pharmacodynamics; pharmacometrics; model-informed drug development; study design; target validation; pharmaceutical/regulatory compliance; pharmacovigilance.