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Executive Recruiter at GForce Life Sciences
Sr. Manager, Clinical Pharmacology
6-month contract - potential to convert to perm
Hybrid - Waltham, MA - 3 days/week
This role supports CNS development programs as part of a Clinical Pharmacology, DMPK, and BA organization. The position serves as a Clinical Pharmacology Lead on cross‑functional project teams, providing subject matter expertise to support dose and regimen selection in patients.
The role integrates PK/PD, quantitative modeling and simulation, drug development knowledge, toxicokinetics, and nonclinical PK (ADME/DMPK). Hands‑on modeling experience is preferred. The position contributes across multiple programs and collaborates closely with chemistry, life sciences, regulatory, and clinical operations teams.
Key Responsibilities
- Support clinical program design, protocols, analysis plans, study reports, and regulatory submissions
- Conduct and oversee PK (NCA) analyses, exposure–response analyses, simulation‑based trial design, dose selection, and population modeling
- Present and defend model‑based strategies to internal governance groups and regulatory agencies
- Write and review clinical pharmacology sections of regulatory documents and responses; participate in regulatory interactions
- Promote model‑informed drug discovery and development through external collaboration, publications, and conference presentations
- Operate effectively in a highly matrixed environment
Qualifications
- PhD or PharmD in Pharmaceutical Sciences, Pharmacometrics, or related field with 3–4+ years of pharmaceutical industry experience
- Experience serving as a Clinical Pharmacology Lead on development programs
- Strong background in clinical pharmacology, pharmacokinetics, and quantitative modeling
- Small‑molecule clinical development experience across multiple study paradigms
- Experience with PK/PD modeling, bioanalytical analysis, and nonclinical ADME
- CNS therapeutic area experience preferred
Technical & Regulatory Experience
- Strong understanding of PK theory, compartmental modeling, simulation, and statistical methods
- Working knowledge of nonclinical and clinical DMPK processes and cross‑functional drug development
- Phoenix programming experience required; Monolix, R, WinNonlin, SAS, or S‑Plus preferred
- Experience with FDA interactions and regulatory submissions (IND, NDA)
- Experience contributing to manuscripts, study reports, and regulatory documents (INDs, NDAs, CTDs)
Seniority level
- Mid‑Senior level
Employment type
- Contract
Job function
- Science, Research, and Other
Industries
- Pharmaceutical Manufacturing and Biotechnology Research