Head Of Clinical Operations H/F

Hepta Medical

Reporting directly to the CEO, working closely with the VP of R&D and the technical and regulatory teams, you will play a key role in leading Hepta Medical's clinical strategy and operations.
Your responsibilities will include:

- Preparation of clinical studies: identifying clinical sites, investigators, and local partners (CROs).
- Regulatory and ethical submissions: coordinating study approvals, ensuring compliance with competent authorities and ethics committees.
- Clinical study management: supervising operational aspects across Europe and internationally to ensure smooth patient enrolment, treatment, and follow-up.
- Data-driven insights: collaborating with the R&D team to analyze clinical data, understand endpoints, and support product claims.
- Continuous improvement: gathering product feedback from clinical use and recommending design or process enhancements.
- Cross-functional collaboration: contributing to transversal projects involving R&D, regulatory affairs, and strategic operations.

What Hepta Medical Has to Offer:

- A key position within a fast-growing MedTech company entering a pivotal phase.
- The opportunity to shape the clinical strategy of an innovative medical device with life-changing potential.
- A dynamic and international work environment, combining technical excellence and purpose-driven innovation.
- A culture that values initiative, autonomy, and collaboration.

Experience and Background

- Around 10 years of experience managing clinical trials within medical device companies.
- Proven track record with Class IIb / III medical devices in clinical contexts.
- Strong knowledge of regulatory, ethical, and operational constraints related to clinical research.
- Engineering background (biomedical or similar).
- Fluent in English, both spoken and written - French is a plus.

Mindset and Soft Skills

- Willingness to travel up to 50% of the time, sometimes on short notice.
- Ability to adapt to multicultural environments and interact with diverse stakeholders.
- Exceptional organizational skills, rigor, and attention to detail.
- Hands-on, autonomous, and entrepreneurial spirit - able to thrive in a fast-paced startup environment.
- Strong interpersonal skills and excellent fit with the leadership team.

Hepta Medical is a MedTech startup developing an innovative thermal ablation device to treat early-stage lung cancer.

Using temperature sensors and advanced imaging, the system can replace surgical techniques by locally monitoring temperature to better control the size of the ablation zone, ultimately offering a safer, less invasive, and more effective treatment for patients.

After raising over €2M in seed funding and completing a €7M Series A round, Hepta Medical is finalizing its prototyping phase, and the device is already in preclinical testing. The system is fully functional, and the company is launching a comprehensive research program to predict lesion morphology.

Over the next 12 months, Hepta Medical's goal is to bring the first version of the device to market in the United States.

Hepta Medical has also been recognized with both the Jury Prize and the Public Prize at the 2024 SNITEM Innovative Medical Device Startup Competition (SNITEM is the leading professional organization representing the medical device industry in France).