Head of Clinical Affairs
Paris
Operations – Medical Operations /
Full-Time /
Hybrid
About this Role:
We are seeking the Head of Clinical Affairs to develop, drive and implement Zoī's clinical strategy, ensuring the successful execution of clinical studies and programs. You will play a pivotal role in representing ZoĪ in the medical and scientific community, building the connection and partnership with the relevant scientific stakeholders, including researchers, key opinion leaders (KOLs), and public institutions required for a successful clinical program. With a strong background in medical device clinical trials, regulatory affairs, and a proven track record of leading teams to achieve exceptional results, you will be crucial in ensuring Zoī's position as a cutting-edge research institution for preventive medicine and an innovative player in the medtech space.
Main missions
- Develop Zoī's clinical strategy in collaboration with medical teams and expert partners, and lead its implementation from start to finish, including study design, protocol development, and each stage of regulatory submission, approval, and publication
- Set up the infrastructure to deliver solid clinical trials, including operating procedures and quality controls to be implemented onsite by practitioners
- Build and maintain relationships with the medical and scientific community, including medical partners, investigators, KOLs, public institutions, and regulatory agencies
- Ensure Zoī's medical knowledge management internally and externally, including participating in scientific and medical congresses as well as implementing internal training programs
- Collaborate with cross-functional teams, including R&D, Regulatory Affairs, and Sales, to align clinical strategies with business objectives
- Provide clinical expertise to other departments at ZoĪ, including Product & Sales, to ensure the quality of medical information that is integrated into our products and shared with clients
- Ensure compliance with all regulatory and ethical standards for clinical trials in multiple jurisdictions, in partnership with QARA
- Recruit and manage the Clinical Affairs team, setting goals, monitoring performance, and fostering professional development.
- Stay abreast of industry trends, clinical practices, and regulatory changes affecting clinical trials and medical devices.
Ideal Candidate Profile
- Advanced degree in a scientific or medical field (MD, PhD, PharmD, or equivalent).
- Minimum of 8 years of experience in clinical affairs or clinical development within the medical device or related healthcare industry.
- Dynamic approach, ability to work at start-up speed, think outside the box, challenge assumptions
- Demonstrated leadership in conducting international clinical studies, from design to publication.
- Extensive knowledge of European regulatory requirements
- Strong analytical skills and experience with statistical methods in clinical trials.
- Excellent communication and interpersonal skills, with the ability to engage effectively with clinical partners, team members, and senior management.
- Strategic thinker with a proactive approach to problem-solving and decision-making.
- Fluent French & English
More about Zoī
Zoī (zoi.com) is a deeptech startup at the intersection of medicine and wellness, founded by Ismaël Emélien and Paul Dupuy. In 2022, they raised 20M Euros in seed capital from leading investors, among which, Stéphane Bancel, Xavier Niel, Jean-Marie Messier, and Rodolphe Saadé.
By combining advances in medicine, data science and behavioral science, Zoī provides its members with a state-of-the art 360° medical check-up, followed by a personalized digital support system to profoundly improve their quality of life and healthspan.
The three pillars of Zoī
1. A network of high-end health centers where members meet their medical team, undergo their check-up and start their preventive health journey
2. A critical algorithm and technology suite facilitating the work of the medical team to analyze holistically the millions of data points generated during the medical check-up and make personalized recommendations for members
3. A mobile application that helps members take daily action to implement recommendations and make qualitative changes in their lives
