Senior Manager of Clinical Affairs

Neptune Medical, is an innovative, venture capital funded medical device startup headquartered in Burlingame, CA. We have already commercialized novel medical devices using our technology. Now the team at Neptune is building something truly unique: a fully flexible medical robot that enables doctors to reach deep into human anatomy. Triton Robotic Endoscopy will disrupt flexible endoscopy and set a new standard in outcomes for decades to come.

TITLE: Senior Manager of Clinical Affairs

POSITION SUMMARY: The Clinical Affairs Senior Manager/Associate Director will be responsible for the design, execution and monitoring of clinical studies and will provide scientific expertise throughout the development and implementation of the studies. This role is accountable for the end-to-end clinical strategy, design, execution, oversight, and reporting of clinical studies supporting product development, regulatory submissions, and commercialization. S/he will work closely with R&D, Regulatory Affairs, Quality and external stakeholders to ensure high-quality, compliant, and efficient clinical programs and interact with regulatory agencies as needed to support regulatory submissions and audits.

The ideal candidate would act with passion and intensity in a medical device start-up that is fast paced and collaborative and display the ability to perform to the requirements outlined below. For the right person, this position will be a tremendously exciting and career-defining opportunity, offering the opportunity to shape clinical strategy for a novel medical robotic platform and to contribute meaningfully to the company’s long-term success.

ROLES AND RESPONSIBILITIES:

 Clinical Strategy and Leadership

• 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.

Study Design, Execution, and Oversight

• 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. 

 Scientific and Regulatory Contributions

• 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.

Data Review, Safety, and Quality

• 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.

Operational and Financial Management

• 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.

REQUIRED 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