Description of Role
Senior Director, Clinical Pharmacology to provide scientific and strategic leadership for clinical pharmacology across a neuroscience pipeline spanning early development through late-stage and registrational programs.
Key Responsibilities
- Lead clinical pharmacology strategy for CNS/neuroscience programs from first-in-human through registrational and post-marketing stages
- Design, execute, and interpret clinical pharmacology studies (FIH, MAD, DDI, biopharmaceutics, patient studies)
- Drive dose selection/optimization integrating PK, PD, safety, efficacy, and CNS-specific biomarkers
- Lead model-informed drug development (population PK, PK/PD, exposure–response analyses)
- Guide CNS exposure, brain penetration, target engagement, and translational biomarker strategies
- Serve as clinical pharmacology lead on program teams and trial working groups
- Author/oversee clinical pharmacology sections of regulatory documents (INDs, CTAs, IBs, NDAs)
- Represent clinical pharmacology in FDA and other global health authority interactions
- Partner with DMPK, Translational Sciences, Clinical Development, Biomarkers, Biostatistics, CMC, and Regulatory Affairs
- Oversee CROs/external vendors; ensure timely communication of results
- Contribute to portfolio strategy, prioritization, risk mitigation, and long-range planning
- Mentor clinical pharmacology talent; ensure submission-ready documentation
Qualifications
- PhD, PharmD, or MD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or related field
- 8–12+ years clinical pharmacology experience in biopharma with impact on clinical drug development
- Strong PK/PD, PK/PD integration, exposure–response, and DDI expertise
- Experience with population PK/mechanistic PK/PD modeling for CNS dose selection
- Proficiency with NONMEM, R, Phoenix WinNonlin, SimCyp, or equivalent
- Experience authoring clinical pharmacology components of IND/CTA/NDA submissions and interacting with authorities
- Strong translational PK/CNS exposure and biomarker integration knowledge
- Excellent communication, collaboration, and leadership in a matrixed, fast-paced environment
Compensation/Benefits (if included)
- Base salary range: $270,000–$295,000; discretionary annual bonus; 401(k); medical/dental/vision/life insurance; paid time off; health and wellness program.