Company: CEFALY Technology
Location: Office is located Darien. Alternate locations will be considered for the right candidate.
Job Title: Vice President Medical & Clinical Affairs
Salary Range: $180,000 - $250,000 plus bonus
Reports To: Chief Executive Officer
About Us: Cefaly Technology is a global leader in the development of innovative medical devices designed to improve the quality of life for those suffering from migraine. Our flagship product, the Cefaly device, is the first FDA-cleared, over the counter, external trigeminal nerve stimulation device for the treatment and prevention of migraine.
Founded on a commitment to scientific excellence and patient-centric innovation, Cefaly Technology combines advanced neuromodulation technology with rigorous clinical research to deliver safe, effective, and non-invasive solutions. Our team is passionate about pushing the boundaries of medical science to develop products that empower people to take control of their health and well-being.
Headquartered in Liège, Belgium & Darien, Connecticut, with a growing global presence, Cefaly Technology is driven by a mission to lead in headache and migraine care through cutting-edge research, education, and technology. We foster a collaborative and inclusive work environment where every team member is encouraged to contribute their expertise, ideas, and creativity.
Joining Cefaly Technology means being part of a forward-thinking company dedicated to making a tangible difference in the lives of millions of people worldwide. We are committed to our employees' professional growth and well-being, offering opportunities to work on groundbreaking projects in a dynamic and supportive atmosphere.
Position Overview: CEFALY Technology is seeking an experienced and visionary Vice President of Medical & Clinical Affairs to lead our clinical research initiatives, collaborate on medical publications, and manage healthcare reimbursement strategies. The ideal candidate will also assist in building a medical advisory board, recruit Key Opinion Leaders (KOLs), and serve as a liaison with headache and migraine foundations. A key focus of the role is direct patient interaction, collaborating with customer service to address complex inquiries regarding Cefaly devices. The role ensures patients receive exceptional support and guidance while also leveraging clinical insights to inform strategic decisions. This role requires a strategic thinker with strong leadership skills and the ability to work cross-functionally to drive the success of our clinical and market access efforts.
Key Responsibilities:
Clinical Studies Management:
- Oversee the design, implementation, and management of clinical studies in collaboration with our medical advisor.
- Ensure compliance with regulatory requirements and maintain high standards of scientific integrity and ethics.
- Develop and monitor study timelines, budgets, and resource allocations.
- Facilitate communication between clinical study teams, investigators, and stakeholders.
Patient Interaction & Support:
- Serve as the primary medical expert for adverse event reporting and patient questions related to device usage.
- Partner with the Customer Service team to ensure medically accurate and compassionate responses to patient inquiries.
- Develop resources to educate and support patients regarding device functionality and use.
Regulatory Compliance:
- Ensure all clinical activities comply with FDA, EMA, and other relevant regulatory bodies.
- Oversee the preparation and submission of clinical data to regulatory agencies.
- Maintain up-to-date knowledge of regulatory requirements and guidelines.
Medical Publications:
- Work closely with the statistician to analyze clinical study data and ensure the accuracy and validity of statistical interpretations.
- Oversee the preparation and review of clinical study reports and other documentation for publication.
- Contribute to the writing and submission of scientific manuscripts for peer-reviewed journals.
Healthcare Reimbursement:
- Lead the development and implementation of reimbursement strategies to ensure optimal coverage and payment for CEFALY devices and electrodes.
- Engage with payers, regulatory bodies, and other stakeholders to advocate for product reimbursement.
- Stay informed about changes in healthcare reimbursement policies and adapt strategies accordingly.
- Provide expertise in health economics and outcomes research to support reimbursement efforts.
Medical Advisory Board and KOL Recruitment:
- Assist in building and maintaining a medical advisory board to provide strategic guidance on clinical and market access initiatives.
- Recruit and engage Key Opinion Leaders (KOLs) to support clinical research, product development, and market access efforts.
- Foster strong relationships with KOLs to leverage their expertise and influence.
Liaison with Headache and Migraine Foundations:
- Serve as the primary liaison for all headache and migraine foundations, building strong relationships and partnerships.
- Represent CEFALY at industry conferences, meetings, and events related to headache and migraine.
- Collaborate with foundations to support awareness, education, and advocacy initiatives.
Leadership and Team Management:
- Mentor and develop team members, providing guidance and support for their professional growth.
- Collaborate with cross-functional teams, including R&D, regulatory, and marketing, to align clinical strategies with overall business goals.
Strategic Planning and Execution:
- Develop and execute a strategic plan for clinical affairs that aligns with CEFALY's vision and goals.
- Identify opportunities for clinical research that can support product development and market access.
- Monitor industry trends and advancements to ensure CEFALY remains at the forefront of clinical innovation.
Qualifications:
- MD, PhD, PharmD, or equivalent advanced degree in a related field.
- Minimum of 10 years of experience in clinical research, with at least 5 years in a leadership role.
- Proven track record in managing clinical studies from design to publication.
- Extensive experience in healthcare reimbursement and knowledge of payer landscapes.
- Strong analytical and statistical skills, with experience in working with biostatisticians.
- Excellent written and verbal communication skills, with a history of successful scientific publications.
- Demonstrated ability to lead and motivate teams in a dynamic, fast-paced environment.
- Strong strategic thinking and problem-solving skills.
- Knowledge of regulatory requirements and guidelines for clinical research.
- Experience in building and managing a medical advisory board and recruiting KOLs.
- Established relationships with headache and migraine foundations are a plus.
Benefits:
- Competitive salary and performance-based bonuses
- Comprehensive health, dental, and vision insurance
- Retirement savings plan with company match
- Generous paid time off and holidays
- Collaborative and innovative work environment
CEFALY is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.