Head of Clinical Affairs Lead
1 maand geleden
At SkinVision, we are seeking a highly experienced and skilled Head of Clinical Affairs to lead our clinical strategy and roadmap. This role involves extensive interaction with key opinion leaders, doctors, researchers, and end-users across the EU and USA.
Key Responsibilities:- Develop and oversee clinical monitoring plans and monitoring of clinical study sites.
- Develop and negotiate study budgets, privacy agreements, and clinical trial contracts.
- 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.
- 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.
- 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.
- Competitive salary based on experience, bonus structure, and additional benefits.
- 3 office days per week with a healthy lunch and 2 days of working from home.
- Company laptop.
- Unlimited skin checks for you, your family, and your friends.
- Regular team events such as weekly drinks and monthly dinners.
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