The role
0301Define and own the design and development strategy for IVD, CTA, tumor profiling, CDx, and/or SaMD programs, aligning analytical and clinical validation and regulatory timelines with biopharma drug development milestones, including IND, Phase I/II/III, BLA, NDA, and MAA.
02Build trusted biopharma partnerships as the primary project contact, maintaining transparency on status, risks, decisions, co-development agreements, technical feasibility scopes, and joint development plans in collaboration with Biopharma Business and Legal.
03Lead internal and joint governance—including portfolio reviews, business stage gates, design reviews, Joint Steering Committees, and Joint Development Teams—to drive aligned, timely decision-making.
04Integrate Bioinformatics and Assay Development, Verification and Validation, Clinical Operations, Regulatory Affairs, Quality Assurance, Manufacturing, Product Management, and Biopharma teams around a coherent program strategy, milestones, resources, and shared accountability.
05Deliver diagnostic programs from requirements definition through product development, verification and validation, regulatory submission, and commercial launch while managing timelines, budgets, risks, resources, and contingency plans.
