About the Role
This role leads the design and execution of clinical pharmacology programs to inform dose selection, dosing regimens, and regulatory submissions across development phases.
Responsibilities
- Lead the development and implementation of clinical pharmacology plans for small molecule therapeutics
- Direct pharmacokinetic and pharmacodynamic modeling and simulation activities
- Collaborate with cross-functional teams to integrate clinical pharmacology insights into trial design
- Oversee bioanalytical strategies and data interpretation for clinical studies
- Provide scientific leadership in dose selection and exposure-response assessments
- Guide regulatory strategy related to clinical pharmacology components
- Prepare and review sections of regulatory submissions including protocols and clinical study reports
- Manage external vendors and consultants involved in pharmacokinetic analyses
- Ensure alignment of clinical pharmacology activities with overall development timelines
- Serve as primary point of contact for clinical pharmacology matters internally and with health authorities
- Develop and mentor team members within the clinical pharmacology function
- Stay current with evolving regulatory expectations in pharmacometrics and trial design
- Evaluate new methodologies to enhance data interpretation and decision-making
- Support interdisciplinary integration of biomarker and clinical data
- Drive efficient use of modeling to reduce clinical trial burden
Compensation
Competitive salary and comprehensive benefits package commensurate with experience
Work Arrangement
Hybrid work model with primary location in Greater Boston area
Team
Part of the clinical development leadership team reporting to the Chief Medical Officer
About the Team
The clinical pharmacology team plays a central role in optimizing trial design and dose selection using quantitative approaches. The group works closely with clinical, regulatory, and translational teams to accelerate development decisions.
Growth Opportunities
This position offers leadership exposure across development stages and direct impact on regulatory strategy and product labeling.
Available for qualified candidates requiring sponsorship
