Lakefrontbiotherapeuticsinc
Director/Senior Director, Clinical Pharmacology
San Francisco, CA. Posted 4 months ago
The role
The Director or Senior Director of Clinical Pharmacology will lead clinical pharmacology strategy and execution across the autoimmune pipeline. This role involves developing clinical pharmacology plans, analyzing trial data, and integrating quantitative modeling to inform dose selection and trial design.
What you will do
- Lead clinical pharmacology strategy and implementation across one or more programs.
- Develop and execute multidisciplinary clinical pharmacology plans.
- Analyze data from clinical trials to identify dose- and exposure-related trends.
- Contribute to the design of clinical studies.
- Integrate quantitative modeling techniques throughout development.
- Oversee and manage CRO clinical pharmacology and modeling vendors.
- Represent the Clinical Pharmacology function on project teams.
- Author and review regulatory documents including IND/IMPD sections and NDA/BLA components.
- Represent the company in interactions with FDA, EMA, and other health authorities.
- Contribute to lifecycle management strategies and support business development due diligence.
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
- Direct experience leading Clinical Pharmacology strategy and execution for clinical-stage programs through IND and beyond
- Strong foundation in the principles of PK, PK/PD, clinical pharmacology, and quantitative modeling techniques
- Working knowledge of R, NONMEM, Phoenix, or equivalent platforms
- Demonstrated experience authoring regulatory documents and interacting with health authorities
- Track record of operating effectively in cross-functional teams in a lean, fast-moving biotech environment
- Strong scientific communication skills
Nice to have
- Experience in immunology, inflammation, or autoimmune disease areas
Benefits
- Comprehensive and generous benefits and programs
About the company
Lakefront Biotherapeutics is a global biotech focused on building a differentiated immunology and inflammation pipeline to address serious diseases. The company operates with small, empowered teams to move programs forward efficiently.