Head of Clinical Affairs

Company Overview:

SkinVision is a pioneering AI start-up on a mission to save 250k lives in the next decade by revolutionizing the early detection of skin cancer. Leveraging cutting-edge technology, our flagship product is a mobile app that employs AI to assess skin lesions and identify potential risks of skin cancer. We empower people to manage their skin health and enable an efficient connection between users and the health system. With over a million existing users and more than 30k new users joining us every month, we are constantly looking to grow our team with professionals who are driven by purpose and are challengers by nature.

Job Summary:

The Head of Clinical Affairs will lead and shape the clinical strategy and roadmap, ensuring the alignment of our product value with the clinical and economic needs of our customers. This role involves extensive interaction with key opinion leaders (KOLs), doctors, researchers, and end-users across the EU and USA. The successful candidate will oversee the planning and execution of clinical studies, ensuring compliance and excellence in all clinical research activities.

Key Responsibilities:

Clinical Strategy and Roadmap Development:

● Understand the healthcare landscape, including customers’ clinical and economic needs, and articulate the product value for our end-users.

● Assess the impact of proposed updates or new products on the clinical evidence strategy and drive the research roadmap definition for the next three years.

● Define the resource requirements and necessary expertise for the research team based on the research roadmap.

● Participate in strategic discussions with B2B partners to ensure the accuracy and alignment of clinical evidence.

Clinical Study Planning and Oversight:

● Develop and oversee Clinical Monitoring Plans and monitoring of clinical study sites. 

● Develop and negotiate study budgets, privacy agreements, and clinical trial contracts. 

● Oversee clinical studies, including database management, EC/CA submissions, and the preparation and execution of site trial training and investigator meetings.

Stakeholder Engagement and Relationship Building:

● Maintain contact and build relationships with KOLs, doctors, and researchers from medical centers.

● Collect feedback from potential end-users in the EU and the USA to inform clinical strategies and product development.

Qualifications:

● Advanced degree in a relevant field (e.g., Medicine, Life Sciences, Clinical Research). ● Minimum 10 years of experience in clinical affairs or clinical research, with significant experience in the medical device industry (preferably softwares).

● Extensive experience in clinical research and development within the healthcare or medical device industry.  

● Extensive knowledge of clinical trial processes and regulatory requirements: EU MDR, FDA, ISO 14155, ISO 13485, and GCP guidelines.

● Proven experience in leading and managing clinical research teams.

● Strong project management and organizational skills.

● Advanced analytical and problem-solving abilities.

● Proven ability to build and maintain relationships with KOLs, doctors, and researchers. ● Exceptional communication and negotiation skills.

● Experience with B2B partnerships and aligning clinical evidence with strategic goals. ● Fluency in English.

● Office tools and Google Workspace.

Preferred qualifications:

● Experience with database management and clinical data software.

● Previous experience in medical writing and scientific publication.

● Familiarity with regulatory submissions and EC/CA processes.

● Knowledge of skin cancer health economics; healthcare systems, market, and patient workflows.

● Fluency in other languages (Dutch and Spanish preferred).

● Technical Medicine or similar degree (in Dutch: technische geneeskunde).

What’s in for you:

● 3 office days per week with a healthy lunch and 2 days of working from home.

● Company laptop.

● A competitive salary based on your experience, a bonus structure and additional benefits (e.g. travel reimbursement and training budget).

● Join our enthusiastic and professional team with colleagues from all over the world. ● A dynamic and rapidly growing scale-up in Amsterdam.

● Unlimited skin checks for you, your family and your friends.

● Regular team events such as weekly drinks and monthly dinners.

Not sure if you are qualified?

Research shows that while men apply to jobs when they meet an average of 60% of the criteria, women tend to only apply when they check every box. If you feel energized by our mission and would like to use your first-class talent to accelerate the growth of SkinVision but don't necessarily meet every single point on the job description, please still apply. We'd love to receive your application and see if you could be a good fit.