Senior Director, Translational Medicine
Core
Lead cross-functional teams to develop biomarker strategies, validate assays, and interpret data to support oncology clinical programs.
Role type
Senior Director, Translational Medicine (Oncology)
Builds
Clinical development plans and biomarker strategies for oncology therapeutics
Domain
Biopharmaceuticals / Oncology
Required skills
Biomarker strategy development, assay validation, clinical trial design, regulatory submissions (IND/NDA/BLA), data analysis, cross-functional leadership
Preferred skills
R, Python, companion diagnostics, predictive/prognostic biomarker evaluation
Technologies
R, Python
Responsibilities
Lead cross-functional Biomarker Subteam(s) to develop and implement comprehensive biomarker strategies; Establish collaborations with research, clinical development, biostatistics, and regulatory teams; Author biomarker sections of clinical protocols; Ensure rigorous analytical validation of biomarker assays; Contribute to health authority interactions and submissions; Ensure compliance with GCP and regulatory guidelines.
Seniority
Senior Director, strategic leadership & hands-on execution