Overview
Hybrid
Depends on Experience
Contract - W2
Skills
NDA
Business Analysis
Business Analytics
Management
Mergers and Acquisitions
Modeling
Pharmacology
Pure Data
Job Details
Location: Hybrid Waltham, MA (3 days onsite)
We are seeking an experienced Clinical Pharmacology Lead to support CNS programs within the Clinical Pharmacology, DMPK, and BA team. The role focuses on dose selection, PK/PD modeling, clinical study support, and regulatory submissions. The ideal candidate brings strong quantitative skills, hands-on modeling experience, and the ability to work independently in a highly matrixed environment.
Key Responsibilities:
- Lead clinical pharmacology strategy for clinical programs.
- Support study design, protocols, analysis plans, and regulatory submissions.
- Conduct/oversee PK (NCA), exposure response, simulations, and population PK/PD modeling.
- Present model-based strategies to internal teams and regulatory agencies.
- Contribute to IND/NDA documents and FDA interactions.
Requirements:
- PhD/PharmD with 3 4+ years industry experience.
- Strong PK/PD and modeling expertise; Phoenix proficiency required.
- Experience with small molecules, DMPK, ADME, and CNS therapeutics preferred.
- Knowledge of FDA guidance and direct regulatory interaction experience.
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