Director, Clinical Affairs (Hybrid - Sunnyvale)

Position Overview:

The Director of Clinical Affairs will specifically focus on defining and executing the clinical evidence strategy supporting new products. This includes planning, designing and managing the execution of clinical trials aligned with company strategy, building and fostering relationships with key opinion leaders in the field (KOLs) and managing the preparation and dissemination of evidence through conferences, publications and marketing materials. This leader will ensure all clinical activities are aligned with business goals, scientifically sound, ethically conducted, and fully compliant with global regulatory standards.

Clinical Strategy & Leadership

• Develop and drive the clinical strategy for current and future products, ensuring alignment with regulatory requirements (e.g., FDA, EMA) and commercial goals.
• Lead the planning, design and execution of clinical trials that drive product validation, adoption and market expansion.
• Serve as the primary clinical interface with Regulatory Affairs, R&D, Go-to-Market and Commercial teams to translate business needs into scientifically valid clinical plans.
• Lead the selection and management of Key Opinion Leaders (KOLs) to advise on study design, clinical data interpretation and long-term strategies.
• Ability to manage multiple projects simultaneously and to solve problems proactively in a fast-paced environment where priorities can shift quickly.
• Represent the company at conferences and be the primary point of contact for key opinion leaders (KOLs)

Protocol & Study Design

• Oversee the design, authoring, and finalization of clinical protocols (e.g., feasibility, pivotal, post-market, registries) to ensure appropriate endpoints, statistical power, and rigorous methodology.
• Provide medical and scientific input on marketing and patient-facing materials.
• Ensure all clinical protocols meet Good Clinical Practice (GCP) and all relevant ethical guidelines.

Data & Regulatory Submissions

• Lead the analysis, interpretation, and final reporting of clinical data, culminating in presentations, abstracts and publications.
• Own the clinical sections of regulatory submissions (e.g., PMA, 510(k), CE Mark), defending the clinical data and strategy during regulatory body discussions and audits.

Leadership & Compliance

• Establish and maintain robust Clinical Quality Systems (CQS) and Standard Operating Procedures (SOPs) for clinical research activities.
• Manage the budget and resource allocation for clinical studies.
• Other responsibilities as assigned by your Manager/Supervisor

What We're Looking For:

• Education: Bachelor’s degree in a life science, engineering, or related discipline. An advanced degree (Ph.D., M.D., Pharm.D., or Master’s) is highly preferred.
• Director: Minimum of 8+ years of progressive experience in Clinical Research/Affairs within the medical device industry.
• Technical Proficiency: Proven track record in designing, executing, and reporting pivotal, randomized clinical trials for medical devices.
• Regulatory Knowledge: Deep, working knowledge of FDA regulations (CFR Title 21), ICH-GCP, and ISO 14155 (Clinical investigation of medical devices).