Job Description
Conceives, executes, and manages multi-disciplinary Clinical Pharmacology development plans and strategies to meet commercial and regulatory requirements. Generates PK/PD study proposals; anticipates and evaluates advances and responds with new strategies. Leads Clinical Pharmacology/PK/PD aspects of multiple projects and evaluates technical/scientific aspects with Clinical Pharmacology and Pharmacometrics management.
Responsibilities
- Accountable for Phase 1–4 study design and clinical pharmacology strategy; represents project(s).
- Leads teams and drives data analyses/interpretation with context (MoA, disease specifics, internal/external data, analysis plans, and model results).
- Authors regulatory documents (protocols, study reports, population PK, exposure-response, CTDs, label sections, investigator brochure sections, white papers).
- Leads clinical pharmacology and biopharmaceutics meetings; represents Clinical Pharmacology on clinical strategy/asset development teams.
- Provides unified clinical pharmacology position to clinical, CMC, and regulatory teams.
- Authors publications; presents at conferences; interacts with KOLs/external stakeholders.
- Conducts due diligence assessments and represents Clinical Pharmacology on business development teams.
- Represents Clinical Pharmacology at regulatory meetings.
Qualifications
Associate Director, Clinical Pharmacology
- PhD (4+ yrs) or PharmD (6+ yrs); Master’s with 12+ yrs; Bachelor’s with 14+ yrs in PK/PBPK/PK-PD/Pharmacometrics/systems pharmacology/drug metabolism/transporters.
- Excellent interpersonal skills; strategic, enterprise view; proven scientific/technical record; leads teams and collaborates cross-functionally.
Senior Clinical Pharmacologist
- PhD (0 yrs) or PharmD (2+ yrs); Master’s with 8+ yrs; Bachelor’s with 10+ yrs; relevant PK/PBPK/PK-PD/Pharmacometrics/systems pharmacology/drug metabolism/transporters.
- Interpersonal skills; works in teams; scientific acumen.
Benefits (explicit)
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees; eligible for long-term incentive programs.