Head of Clinical Affairs - medical device start-up (REMOTE)
On-siteCambridge, Massachusetts, United States
Job Summary
Lead clinical strategy and execute the pivotal FDA IDE study for a Class II implant start-up, managing site selection, enrollment, and risk mitigation across the US and Brazil. Oversee CRO and vendor selection, finalize site budgets and IRB approvals, and drive patient recruitment to meet enrollment targets within the operating plan. Serve as the primary clinical subject matter expert for executive leadership, the Board, and investors while ensuring strict adherence to GCP and ISO 14155 guidelines. Collaborate closely with investigators to support regulatory submissions and prepare materials for investor presentations and scientific publications. This full-time remote role requires a US Citizen or GreenCard holder with 10+ years of clinical study execution experience.
Required Qualifications
- 10+ years of clinical study execution & submission experience in the medical device industry
- Demonstrated experience leading FDA IDE pivotal clinical studies through execution
- Deep understanding of FDA regulations governing medical device clinical trials, including IDE requirements, Good Clinical Practice (GCP), and ISO 14155
- Experience managing CROs and external clinical vendors
- Strong knowledge of clinical study design, execution, monitoring and data management
- Experience implementing clinical SOPs
Desired Qualifications
- experience leading clinical strategy for Class II implant start-up
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