Clinical Strategy Lead, Medical Robotics

Neptune Medical; Burlingame (CA); Sur place; USD 183 000 - 229 000; Plein temps

Résumé du poste

Neptune Medical in Burlingame, CA, is developing a fully flexible medical robot for advanced endoscopy. The Senior Manager of Clinical Affairs will lead end-to-end clinical studies, shape regulatory submissions, and guide evidence-generation across the product lifecycle.

The role collaborates with R&D, Regulatory, Quality, and external partners to ensure compliant programs, timely trials, and robust data. A startup mindset and strong leadership are essential to advance this groundbreaking

Qualifications

• B.S. in Biomedical Engineering, Life Sciences or similar.
• 7-10+ years of progressive experience in clinical research within the medical device industry, including leadership of complex clinical studies.
• Demonstrated experience developing and executing clinical strategies that support regulatory submissions and product approvals.
• Strong working knowledge of Good Clinical Practice (GCP), FDA and international regulations, ISO standards and clinical research best practices.
• Proven ability to lead cross-functional teams and influence without direct authority.

Responsabilités

• Lead the development and execution of the overall clinical strategy aligned with company and regulatory objectives.
• Provide expert input into clinical development plans, trial design, and evidence-generation strategies across the product lifecycle.
• Advise senior leadership on clinical risks, opportunities, and trade-offs.
• Oversee the design, initiation, execution, monitoring, and closeout of clinical studies, ensuring adherence to timelines, budgets, and quality standards.
• Provide strategic oversight of CROs, vendors, investigators, and internal teams to ensure effective study conduct.
• Establish and monitor study performance metrics; proactively identify risks and lead cross-functional mitigation strategies.
• Participate in the development of clinical strategy and trial design.
• Lead the development and review of key clinical documents, including protocols, amendments, investigator brochures, informed consent forms, case report forms, and clinical study reports.
• Interpret and synthesize clinical, scientific, and risk data to support regulatory submissions, scientific publications, and labeling claims.
• Facilitate regulatory submissions and communications. Interacts with regulatory agencies as needed and use scientific and medical knowledge to write strategic responses to questions from regulatory bodies about submissions.
• Provide oversight of clinical data review, including safety and adverse event evaluation, throughout study conduct and reporting.
• Ensure clinical activities are conducted in compliance with GCP, FDA, ISO, and applicable international regulations.
• Partner with Quality to develop and implement SOPs, support audits, complaint review, and implementation of corrective and preventive actions.
• Provide strategic oversight of clinical trial budgets, timelines, and resource planning.
• Lead or oversee contract negotiations with investigators, institutions, CROs, and other vendors.
• Drive continuous improvement of clinical processes, systems, and best practices.

Connaissances

Leadership

GCP knowledge

Regulatory submissions

Clinical trial oversight

Medical terminology

Cross-functional collaboration

Strong communication

Analytical/problem-solving

Startup environment

Domestic/international travel

Formation

B.S. in Biomedical Engineering or Life Sciences

Master's degree preferred

Description du poste

Neptune Medical in Burlingame, CA, is developing a fully flexible medical robot for advanced endoscopy. The Senior Manager of Clinical Affairs will lead end-to-end clinical studies, shape regulatory submissions, and guide evidence-generation across the product lifecycle.

The role collaborates with R&D, Regulatory, Quality, and external partners to ensure compliant programs, timely trials, and robust data. A startup mindset and strong leadership are essential to advance this groundbreaking