Clinical Pharmacology Lead

1 week ago Be among the first 25 applicants

Direct message the job poster from 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 Pharm
  
  D 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, Win Nonlin, 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)

• Mid‑Senior level

• Contract

• Science, Research, and Other

• Pharmaceutical Manufacturing and Biotechnology Research