Director, Clinical Pharmacology

Onsite requirement: 3x/week in Waltham, MA office.

Responsibilities
- Contribute to clinical program design, trial protocols, analysis plans, study reports, and regulatory submissions.
- Conduct and oversee pharmacokinetic (NCA) analysis, exposure-response analysis, simulation-based trial design and dose selection, and population clinical pharmacology modeling.
- Present and defend model-based approaches to internal governance boards and regulatory agencies.
- Write or review clinical pharmacology components of regulatory documents and responses; participate in regulatory interactions.
- Promote model-informed drug discovery and development via external collaboration, journal publication, and conference presentations.
- Function effectively in a highly matrixed team environment; provide sound independent clinical pharmacology input as needed.

Qualifications
Basic
- Ph.D. or Pharm.D. in Pharmaceutical Sciences, Pharmacometrics, or related field; at least 10 years of clinical pharmacology experience in the pharmaceutical industry, including serving as clinical pharmacology lead on development programs.

Preferred
- Strong understanding of clinical pharmacology, biopharmaceutics, and pharmaceutical sciences.
- Knowledge of cross-functional drug development interfaces; detailed clinical pharmacology/PK knowledge.
- Programming experience (e.g., NONMEN, Phoenix NLME, R, WinNonlin).
- FDA regulatory guidance knowledge for DMPK/clinical pharmacology; direct FDA interaction and IND/NDA experience required.
- Experience with non-compartment and model-based PK/PK-PD analyses; scientific writing and peer-reviewed publications.
- Leadership/communication/time-management skills; direct management of internal/external personnel.

Compensation/benefits
- Annual base salary: $228,000–$246,000; eligible for annual performance pay bonus.