We are representing a Boston-based medtech startup developing a novel combination product at the intersection of device, software, and therapeutics. The company is early-stage, well-funded, and preparing to advance its first clinical programs.
About the Role:
The Director of Clinical Operations will build and lead clinical execution from the ground up. This role owns end-to-end clinical operations strategy and execution, partnering closely with Clinical, Engineering, Regulatory, Quality, and external vendors to deliver compliant, efficient clinical studies that support regulatory approval and commercialization of a combination product.
This is a hands-on leadership role ideal for someone who thrives in fast-moving startup environments and is comfortable operating both strategically and tactically.
Key Responsibilities
- Own clinical operations strategy and execution across feasibility, start-up, conduct, and close-out of clinical studies (US and ex-US).
- Build and manage clinical study plans, integrated timelines, budgets, and risk mitigation strategies.
- Lead CRO and vendor selection, contracting, and ongoing performance management.
- Partner with Regulatory and Quality to support IDE, IND/CTA, and other regulatory submissions relevant to combination products.
- Ensure compliance with GCP, ISO 14155, FDA, and global regulatory requirements.
- Oversee site selection, initiation, monitoring, enrollment, and close-out activities.
- Support protocol development, ICFs, safety reporting, and TMF oversight.
- Serve as the primary clinical operations point of contact for internal leadership and external stakeholders.
- Build and scale clinical ops infrastructure, processes, and systems (CTMS, eTMF, SOPs) appropriate for an early-stage company.
- Provide clear status updates, dashboards, and risk assessments to executive leadership and the Board as needed.
Qualifications
- Bachelor’s degree in Life Sciences, Engineering, Nursing, or related field; advanced degree preferred.
- 8–12+ years of clinical operations experience in medtech, biotech, or combination products.
- Proven experience leading clinical studies for medical devices and/or combination products in early-stage settings.
- Strong working knowledge of GCP, ISO 14155, FDA regulations, and combination product development pathways.
- Demonstrated experience managing CROs, sites, and external vendors.
- Comfortable building processes from scratch and operating with limited infrastructure.
- Excellent leadership, communication, and problem-solving skills.
Nice to Have
- Experience with Class II/III devices or drug-device combination products
- Prior startup or first-in-human experience
- Experience supporting IDEs, INDs, or early regulatory interactions
- Hands-on experience with CTMS and eTMF implementation
What’s in It for You
- Opportunity to build clinical operations from the ground up
- High visibility with executive leadership
- Competitive compensation and equity
- Meaningful impact on a novel, patient-focused technology