Director, Clinical Pharmacology
Title: Director, Clinical Pharmacology
Location: Greater Philadelphia Area (Hybrid)
Key Responsibilities
- Lead and execute integrated Clinical Pharmacology strategies spanning Phase 1 through registration and post-marketing development
- Drive dose selection, dose optimization, dose justification, and dosing recommendations through integration of PK, PD, safety, and efficacy data
- Design, oversee, interpret, and communicate results from Phase 1 and dedicated Clinical Pharmacology studies
- Contribute to development strategies supporting regulatory milestones, including INDs, NDAs, BLAs, and global health authority interactions
- Develop and implement Model-Informed Drug Development (MIDD) strategies to optimize development decisions
- Support submission-related Clinical Pharmacology documentation and regulatory responses
Required Qualifications
- PhD, PharmD, or equivalent advanced degree in Pharmacology, Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or a related discipline
- Significant industry experience in Clinical Pharmacology supporting both early- and late-stage drug development
- Direct experience leading Clinical Pharmacology strategies for programs advancing from Phase 1 through registration
- Experience supporting regulatory submissions, including NDA and/or BLA filings
- Proven experience working cross-functionally and influencing development strategy
- Hands-on quantitative pharmacology experience, including:
- Population Pharmacokinetic (PopPK) modeling
- Physiologically Based Pharmacokinetic (PBPK) modeling
- Exposure-Response (E-R) analyses
- PK/PD modeling and simulation
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