Senior Clinical Operations Director
hace 3 semanas
Empresa Reconocida is revolutionizing cardiology through innovative AI-powered solutions. Our technology is transforming the landscape of heart disease prevention, enabling timely diagnosis and treatment for patients worldwide.
Your RoleWe're seeking an experienced Senior Clinical Operations Director to help shape the clinical development strategy of our products. As a key member of our team, you will be responsible for leading the clinical affairs function, ensuring clinical trials are conducted per protocol in a timely manner, and compliant with regulatory guidelines.
Key Responsibilities:- Lead clinical study design and execution, including supporting start-up activities, enrollment, site management, data collection, and site feasibility.
- Support data generation strategy and clinical evidence generation, working closely with product, R&D, and commercial teams.
- Guide medical and scientific direction in the preparation and submission of regulatory dossiers and serve as the medical/scientific representative at regulatory meetings.
- Map out Key Opinion Leaders (KOLs) in relevant areas, engage, and consult to guide the development of our clinical development strategy.
We're looking for an exceptional candidate with:
- M.D. or Ph.D. in a medical or biology-related field.
- 5+ years of experience in driving cardiology-related clinical studies or clinical evidence development for diagnostics or medical devices.
- Extensive knowledge in clinical study design and protocol writing, including IRB writing and biostatistics.
- Strong project management skills with attention to detail and experience translating detail to execution of clinical strategies.
- Excellent communication skills and ability to work collaboratively with cross-functional teams.
- Experience in clinical software and medical devices, preferred.
We offer a competitive salary range of $150,000 - $200,000 per year, depending on experience, plus benefits and opportunities for professional growth.
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