Associate Director / Director, Clinical Pharmacology
About The Position
The Associate Director / Director of Clinical Pharmacology will serve as the scientific and strategic leader supporting Phase 1 studies and inclusion of clinical pharmacology assessments in early development and responsible for the design and execution of clinical pharmacology studies to inform clinical development. This individual will contribute to the planning, implementation, and delivery of studies supporting early- and late-stage clinical trials, lead data interpretation to guide development decisions, and collaborate closely with Clinical Development, Translational Medicine, Biomarkers, and Regulatory Affairs. The role also includes oversight of PK sample strategy, bioanalytical testing, and data integration to support pharmacokinetic (PK), pharmacodynamic (PD), and exposure–response analyses to support dose selection and therapeutic optimization.
Requirements
- PhD, PharmD, or MD in Pharmacology, Pharmaceutical Sciences, or a related discipline.
- 5+ years of clinical pharmacology experience in the biotech or pharmaceutical industry, including leadership roles in clinical-stage development.
- Demonstrated expertise in clinical pharmacology strategy and study design from early development through registration.
- Deep understanding of PK/PD principles, modeling and simulation, and exposure–response analysis.
- Experience overseeing PK sample management, bioanalytical testing, and assay validation.
- Demonstrated cross-functional leadership and ability to integrate complex scientific data into strategic development decisions.
- Excellent communication skills, with the ability to present to senior leadership and external stakeholders.
Nice To Haves
- Quantitative data analysis and visualization skills desired.
- Oncology experience strongly preferred.
Responsibilities
- Design and implementation clinical pharmacology strategies to Treeline’s programs to support IND, first-in-human, proof-of-concept, and registrational studies.
- Develop and execute clinical pharmacology plans, including PK/PD modeling, dose selection, and exposure–response analyses.
- Oversee collection, processing, and analysis of PK samples across clinical programs to ensure data quality and scientific integrity.
- Partner with Translational Medicine, Toxicology, and Biomarkers teams to design and interpret studies supporting mechanism of action, safety, and efficacy.
- Provide scientific and operational oversight for bioanalytical assay development, validation, and sample testing conducted at internal and external laboratories.
- Oversee and/or conduct PK data analysis and its integration with pharmacology and biomarker datasets to support clinical decision-making and regulatory submissions.
- Represent Clinical Pharmacology in cross-functional program teams, contributing to protocol design, statistical analysis plans, and regulatory documentation.
- Contribute to preparation of key sections of clinical study reports, investigator brochures, and regulatory filings (IND, NDA, BLA).
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
