Director/Senior Director, Clinical Pharmacology
$230,000–$300,000 year
Hybrid · San Francisco, California, United States
Job Summary
Director or Senior Director of Clinical Pharmacology to lead strategy and execution across Lakefront Biotherapeutics' autoimmune pipeline. This role shapes how molecules are characterized, dosed, and differentiated in the clinic by applying quantitative modeling (PK, PK/PD, PBPK, QSP) and contributing to regulatory strategy and submissions (IND/IMPD, NDA/BLA). You will oversee CRO/vendors, collaborate with clinical, regulatory, translational, CMC, and other teams, interact with FDA/EMA, influence dose selection and lifecycle management, and help build best-in-class Clinical Pharmacology capabilities as the organization grows.
Required Qualifications
- Ph.D. in Pharmacokinetics, Pharmacology, Pharmaceutical Sciences, or a closely related discipline; PharmD considered with relevant industry experience
- 10+ years (Director) or 15+ year (Senior Director) of industry experience in clinical pharmacology, with direct experience leading Clinical Pharmacology strategy and execution for clinical-stage programs through IND and beyond
- Strong foundation in PK, PK/PD, clinical pharmacology, quantitative modeling techniques, compartmental and noncompartmental analysis, and population modeling; working knowledge of R, NONMEM, Phoenix, or equivalent platforms
- Demonstrated experience authoring regulatory documents and interacting with health authorities
- Experience in immunology, inflammation, or autoimmune disease areas strongly preferred
- Track record of operating effectively in cross-functional teams in a lean, fast-moving biotech environment
- Strong scientific communication skills, both written and oral
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