Director, Companion Diagnostic Program Manager

Role: Director, Companion Diagnostic Program Manager, leading strategic and operational efforts for developing and validating CDx assays across oncology portfolios. Responsibilities include guiding CDx strategy from early to late-stage development, ensuring alignment with clinical, regulatory, and commercial milestones; managing external diagnostic partnerships; and collaborating with cross-functional teams such as Translational Sciences, Regulatory, and Market Access. Requirements: Bachelor’s in Biological Sciences or related field; 10+ years in diagnostics/pharma, with at least 7 years in project management or leadership roles; experience in oncology biomarker-driven strategies, analytical/clinical validation, and regulatory processes. Preferred: familiarity with global regulatory interactions, complex program budgets, and vendor management. High-Value: oncology and immuno-oncology, biomarker-based patient selection, companion diagnostics development, regulatory submissions, and global approvals. Work Setup: Hybrid (Princeton, NJ, 60%), US-based with travel as needed.