KEY RESPONSIBILITIES
- Lead clinical pharmacology strategy and execution, including PK and ADA method development, PK/PD modelling, clinical sample analysis, dose justification, safety margin assessment, and strategies for patient stratification or dose adjustment
- Work with CROs, laboratories, and—where needed—specialized consultants to lead the design, development, qualification, validation, and scientific oversight of PK and ADA assays, ensuring high-quality execution and robust data interpretation.
- Incorporate quantitative endpoints and modelling approaches (PK/PD, exposure response, biomarker-based) into clinical studies to demonstrate target engagement and pharmacologic mechanism
- Provide strategic oversight and recommendations on endpoints, study design, safety evaluations, and dose selection across clinical-stage assets
QUALIFICATIONS
- Advanced scientific degree in molecular or cancer biology, or a similar field (Ph.D., Pharm.D., M.D.) •
- Minimum 10 years of relevant industry experience in Clinical Pharmacology with 4+ years in a leadership role driving strategy and execution.
- Antibody experience strongly preferred; additional experience with biologics including ADC, TCE, immunotherapies, or targeted oncology agents is advantageous
- Demonstrated expertise in clinical pharmacology, including PK/PD modeling, dose selection/justification, safety margin assessment, and immunogenicity/ADA evaluation