Vice President, Clinical Affairs

at  Cefaly Technology

VICE PRESIDENT, CLINICAL AFFAIRS

CEFALY Technology is seeking an experienced and visionary Vice President of 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. 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.

• This position will be located in our Darien, CT office. Alternate locations may be considered for the right candidate.

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.

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.
• 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 [Company Name] products.
• 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:
• Build and lead a high-performing clinical affairs team, fostering a culture of excellence, collaboration, and continuous improvement.
• 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.

CEFALY Technology is seeking an experienced and visionary Vice President of 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. 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.

• This position will be located in our Darien, CT office. Alternate locations may be considered for the right candidate