Associate Director / Director, Clinical Pharmacology

The role

The Associate Director / Director of Clinical Pharmacology will lead the design and execution of clinical pharmacology studies to inform clinical development. This person will support Phase 1 studies and include clinical pharmacology assessments in early development.

What you will do

• Design and implementation clinical pharmacology strategies 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.
• Partner with Translational Medicine, Toxicology, and Biomarkers teams to design and interpret studies.
• Provide scientific and operational oversight for bioanalytical assay development, validation, and sample testing.
• Oversee and/or conduct PK data analysis and its integration with pharmacology and biomarker datasets.
• Represent Clinical Pharmacology in cross-functional program teams.
• Contribute to preparation of key sections of clinical study reports, investigator brochures, and regulatory filings.

Required qualifications

• 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 have

• Quantitative data analysis and visualization skills
• Oncology experience

About the company

Treeline Biosciences is a multi-state employer.