Director, Clinical Affairs (Hybrid - Sunnyvale)
Core
Define and execute clinical evidence strategy for new medical device products, leading clinical trials and regulatory submissions.
Role type
Director, Clinical Affairs (Medical Device)
Builds
Clinical evidence packages, regulatory submissions (PMA, 510(k), CE Mark), and clinical trial protocols.
Domain
Medical technology / Neurological diagnostics / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial design and execution, regulatory strategy (FDA/EMA), KOL management, protocol authoring, clinical data analysis, budget management, GCP/ISO 14155 compliance
Preferred skills
Advanced degree (Ph.D., M.D., Pharm.D., or Master's), experience in pivotal randomized clinical trials
Technologies
FDA CFR Title 21, ICH-GCP, ISO 14155
Responsibilities
Develop clinical strategy aligned with business goals; lead planning and execution of clinical trials; manage Key Opinion Leaders (KOLs); oversee protocol design and finalization; lead clinical data analysis and regulatory submissions; establish Clinical Quality Systems (CQS) and SOPs.
Seniority
Director, strategic leadership with hands-on execution
