About the role
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.
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).