Neptune Medical
Senior Manager of Clinical Affairs
Burlingame, California, United States · Senior
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About the role
- 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.
- Advise senior leadership on clinical risks, opportunities, and trade-offs.
- Provide strategic oversight of CROs, vendors, investigators, and internal teams to ensure effective study conduct.
Responsibilities
- 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.
- Oversee the design, initiation, execution, monitoring, and closeout of clinical studies, ensuring adherence to timelines, budgets, and quality standards.
- 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.
- Partner with Quality to develop and implement SOPs, support audits, complaint review, and implementation of corrective and preventive actions.
Requirements
- Strong working knowledge of Good Clinical Practice (GCP), FDA and international regulations, ISO standards and clinical research best practices
- Ability to thrive in a fast-paced, evolving startup environment with a hands-on, ownership-oriented mindset
- Ability to travel up 20% domestically and internationally
Nice to have
- Master's degree or higher in Biomedical Engineering, Life Sciences, or a related discipline
- Experience or knowledge of the GI/endoscopy space
- Our job titles may span more than one career level.
Compensation
- The starting base salary for this role is between $182,500 and $229,000 depending on experience.
Benefits
- Interacts with regulatory agencies as needed and use scientific and medical knowledge to write strategic responses to questions from regulatory bodies about submissions.
Company info
- 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.
- Senior Manager of Clinical Affairs
This listing is sourced directly from Neptune Medical's careers page and normalized into a canonical job model.