Senior Manager of Clinical Affairs

Regulatory Toolkit; Burlingame (CA); Vor Ort; USD 183.000 - 229.000; Vollzeit

Zusammenfassung

Neptune Medical in Burlingame, CA is seeking a Senior Manager of Clinical Affairs to lead the end-to-end design, execution, and oversight of clinical studies for a novel robotic platform. You will ensure high-quality, compliant programs that support regulatory submissions and eventual commercialization, working closely with R&D, Regulatory, QA and external partners.

The role demands strategic vision, hands-on leadership in a fast-paced startup, and the ability to manage budgets, CROs, and

Qualifikationen

• B.S. in Biomedical Engineering, Life Sciences or similar.
• 7–10+ years of clinical research experience in medical devices, including leadership of complex clinical studies.
• Experience developing and executing clinical strategies supporting regulatory submissions.
• Strong working knowledge of GCP, FDA and international regulations, ISO standards.

Aufgaben

• Lead the development and execution of the overall clinical strategy aligned with company and regulatory objectives.
• Oversee the design, initiation, execution, monitoring, and closeout of clinical studies with timelines and budgets.
• Provide strategic oversight of CROs, vendors, investigators, and internal teams.
• Develop and review clinical documents for regulatory submissions and audits.

Kenntnisse

Clinical strategy

Regulatory submissions

Leadership

Cross-functional teamwork

Regulatory knowledge

Communication

Problem solving

Travel flexibility

Ausbildung

B.S. in Biomedical Engineering

Master’s degree in Biomedical Engineering/Life Sciences

Jobbeschreibung

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 fordecades 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 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.

Neptune Medical provides equal employment opportunities to all applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.