Job Description
📋 Description Lead translational strategy for pipeline assets from candidate through IND and Phase 1. Manage IND-enabling activities including PK/PD, safety, and biomarker packages. Build and scale the translational science function as programs grow. Partner with Research, Clinical Development, and Regulatory to align milestones. Represent translational science in FDA interactions and regulatory documents. Identify and coordinate with external partners (CROs, biomarker labs) to support programs. 🎯 Requirements Ph.D., M.D., or MD/PhD in oncology, pharmacology, cancer biology, or related field. 12+ years in translational oncology drug development, leading two programs to IND/Phase 1. Deep understanding of IND-enabling studies and preclinical data for FDA. Hands-on PK/PD, biomarker strategy, and dose selection for oncology. Strong scientific writing skills with experience authoring regulatory documents. Ability to work at bench-to-bedside interface in a small, fast-moving team. Preferred qualifications Experience with solid tumor indications. Prior experience transitioning from preclinical to clinical stage. Comfort across diverse modality types (small molecules, biologics, ADCs). Experience collaborating with bioinformatics or computational biology teams on biomarker discovery, patient stratification, translational data analysis.
