Director Clinical Pharmacology & DMPK

Summary:

A fast‑growing biopharmaceutical company in the immunology space has engaged GForce Life Sciences to provide a Director / Senior Director of Clinical Pharmacology consultant. This position will report into the Clinical Pharmacology leadership team and directly support multiple active development programs.

This individual will be responsible for providing clinical pharmacology and quantitative pharmacology expertise across early clinical development, including first‑in‑human studies, translational modeling, and regulatory‑supportive analyses. The role requires independent scientific judgment, hands‑on modeling, and decision‑making across several concurrent programs.

This consultant will help relieve an overstretched team supporting positive Phase 3 data, upcoming filings, and the advancement of at least one new compound into clinical development this year. The consultant is expected to integrate closely with internal teams and rapidly contribute at a senior level.

Specific responsibilities include but are not limited to:

• Lead clinical pharmacology strategy, dose selection, and PK/PD and biomarker planning across early and late-stage programs.
• Conduct and interpret PK, PK/PD, exposure–response, and simulation analyses using tools such as NONMEM, WinNonlin, R, Python, and Simcyp.
• Integrate translational and nonclinical PK/PD data to support FIH dose projections and DDI assessments.
• Oversee bioanalytical CROs, ensuring high-quality PK/PD/biomarker data and GLP/GCP compliance.
• Partner with Clinical Operations on sample management and protocol design.
• Communicate quantitative findings clearly and contribute to regulatory documents (protocols, IBs, INDs, NDAs, IMPDs).
• Collaborate across Clinical Development, Biostats/Data Science, Nonclinical, and Program Management.

Key Requirements and Qualifications

• PhD, PharmD, or equivalent in Pharmacokinetics, Pharmacology, or related field.
• 6 to 8 years of industry experience in Clinical Pharmacology, DMPK, or Quantitative Pharmacology.
• Strong expertise in PK, PK/PD, DMPK, and translational sciences.
• Proficiency with modeling/simulation platforms (NONMEM, WinNonlin, Simcyp, R, Python).
• Excellent communication, organization, and ability to work independently in a fast-paced environment.

Terms/Start

• Contract Length: Minimum 6 months with strong potential for extension
• Start Date: ASAP (contractor can start faster than FTE)
• Work Schedule: Full time (40 hours/week)
• Extension / Conversion: Extension possible; long‑term hire under consideration
• Hybrid preferred (Bay Area: 2–3 days onsite/week)
• Remote possible for highly experienced consultants, with periodic onsite meetings