Ground floor opportunity to establish and lead Clinical Operations, and potentially Regulatory Affairs, at a well-funded, early stage medical device company with bioactive orthopedic implants that have demonstrated very promising outcomes in over 140 patients to date, with more studies to follow. These devices significantly improve healing in a common knee surgery that fails too often, thus requiring further operations, risks and costs. The position reports to the CEO, who is a highly successful industry veteran. The company has solid financial backing from US and international investors, and the NFL Players Association. The successful candidate will have a proven track record planning and executing clinical programs that meet objectives and milestones on time and on budget. This Senior Director will have principal responsibility for the strategic and tactical execution of the clinical trials that lead to successful approval and commercialization of the company’s innovative products. Job scope includes surgeon investigator interaction, selecting and managing a CRO, and overseeing site contracts, clinical supplies, the clinical trial master file, and all the deliverables related to the studies.
- Serve as leader and champion for all aspects of the company’s medical device Clinical Research Program, and ensure that clinical trials are properly resourced, managed and executed.
- Develop protocols, SOPs, clinical timelines and budget forecasts, and staffing plans.
- Set up and initiate clinical studies, work with sites, and attend surgical cases as needed.
- Review master service agreements, statements of work, clinical operations quality agreements.
- Encourage and support Principal Investigator engagement and relationships.
- Provide oversight of CROs and vendors if needed, from identification, to selection, and close of contracts.
- Collaborate with QA to ensure that clinical trials comply with applicable regulations.
- Write clinical study and safety reports, Investigator Brochures, publications/presentations.
Qualifications / Experience:
- BS or greater in a life sciences field, with demonstrated academic success.
- 15+ years medical device clinical research /clinical trials / clinical monitoring experience, including 8+ years in a clinical operations leadership role, in the medical device industry. Orthopedics is a plus.
- Demonstrated success designing, implementing and managing medical device clinical studies and operations from strategy to implementation, data collection, conclusion and submission.
- Experience managing CROs and vendors throughout entire clinical operations life cycle.
- Excellent working knowledge of FDA, EU, Japanese regulatory expectations, GCPs, ICH guidelines.
- Successful experience in FDA negotiations on the conduct of medical device clinical trials.
- Strong understanding of statistical techniques and applications, scientific rigor, data traceability.
- Successful track record of working with surgeons, KOLs, clinical trials site personnel, and IRBs.
- Travel to support the clinical trials, meet investigators, and oversee the CRO’s monitors.
- Results oriented, ‘roll-up your sleeves and do what‘s needed’ attitude necessary in a start up.
- Excellent verbal and technical writing skills.
- Strong organizational, project management, and people skills.