Position Summary
Director, Oncology Clinical Pharmacology Modelling and Simulation (CPMS) (Hybrid)
Responsibilities
- Define and execute model-based development strategies for oncology projects.
- Plan, conduct, and report population PK and exposure-response analyses; simulation-based trial design and dose selection.
- Present strategy and defend model-based outcomes to internal 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 to support approvals and optimum labeling.
- Interact with line/middle management, staff, and external contacts strategically and tactically.
- Apply drug-disease modeling, longitudinal exposure-response, model-based meta-analysis, quantitative systems pharmacology, and AI/ML-informed analyses.
- Implement best practices and lessons learned to advance CPMS contributions to the R&D pipeline.
- Promote model-informed drug discovery/development via external collaboration, journal publication, and conference presentation.
Qualifications (Required)
- PhD in Quantitative Clinical Pharmacology and Pharmacometrics (e.g., pharmacology, engineering, statistics) plus modeling/simulation experience in industry/academia; or PharmD/Masterβs with 3+ years relevant experience.
- 5+ years leveraging population PK and exposure-response modeling; proficiency in NONMEM or R.
- 3+ years planning, performing, and reporting model-based analysis of clinical data per industry/regulatory standards.
Preferred
- Oncology drug development experience; knowledge of oncology disease biology/mechanisms/trial design/endpoints.
- Advanced pharmacometrics (mechanistic PKPD, longitudinal disease modeling, model-based meta-analysis, adaptive dosing).
- Experience with AI/ML in pharmacometrics; collaboration; stakeholder management; MID3 track record.
Working Arrangement
- Hybrid; on-site 2β3 days/week.
Benefits/Compensation
- US base salary (Cambridge, MA; Waltham, MA; Rockville, MD; San Francisco, CA): $188,100β$313,500; annual bonus; share-based long-term incentive; health/insurance, retirement, paid holidays/vacation, caregiver/parental and medical leave.