Demonstrated experience managing strategic biopharma, biotechnology, customer, clinical, CRO, or technology-partner relationships, including expectation-setting, commitment negotiation, escalation management, and resolution of competing priorities across internal teams, clinical sites, laboratories, consultants, and vendors. Working knowledge of regulated product development sufficient to plan and govern execution, including 21 CFR Part 820 design controls, ISO 13485 principles, clinical/analytical validation, risk management, traceability, and quality systems.