TITLE: Senior Manager of Clinical AffairsPOSITION 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 direct authority.
- Excellent written and verbal communication, skills including experience presenting to senior leadership and regulatory agencies
- High attention to detail and accuracy
- Fluent in medical terminology and sound knowledge of anatomy
- Strong analytical, problem-solving, and decision-making skills with high professional judgment.
- Ability to thrive in a fast-paced, evolving startup environment with a hands-on, ownership-oriented mindset
- Takes initiative and acts quickly to drive to solutions with a driven outlook and with a strong desire to succeed as a team player, and as a key part of a company
- Ability to travel up 20% domestically and internationally
PREFERRED QUALIFICATIONS:- Experience in medical robotics
- Master's degree or higher in Biomedical Engineering, Life Sciences, or a related discipline
- Experience or knowledge of the GI/endoscopy space
Neptune Medical is located in Burlingame, CA, near the Millbrae Caltrain and BART Station
Our job titles may span more than one career level. The starting base salary for this role is between $182,500 and $229,000 depending on experience. The actual base pay is dependent upon many factors, such as: education, training, transferable skills, work experience, business needs, and location. The base pay range is subject to change and may be modified in the future. This role may also be eligible for equity, benefits and 401(K) with matching.
