VP Clinical & Market access CH867525

Our client, a cutting-edge medical device startup in the aortic EVAR field, is looking for an experienced senior executive leader who will report to the CEO and will lead US Clinical Therapy Development & Market access.

The position is based in the United States.

The responsibilities of the VP of Clinical Therapy Development & Market Access are in the following 3 areas:

POSITION RESPONSIBILITIES

Clinical Development

• Oversee the execution of clinical trials in the US alongside VP Clinical Affairs.
• Build a US based team to support the execution of the clinical trials e.g., Clinical Field Specialists.
• Design and execute patient recruitment plan in collaboration with the VP Clinical Affairs to ensure timely execution of the clinical studies.
• Design and implement robust tracking systems to monitor patient enrolment progress, identify bottlenecks, and streamline the enrolment process.
• Work closely with clinical sites, investigators, and other stakeholders to facilitate activities for patient enrolment.
• Align closely with the clinical team to ensure all sites receive the highest levels of training and motivation during study execution.
• Build and lead all aspects of the clinical education and training programs for the clinical field specialists including field visits to sites, attending clinical cases, and developing training materials.

Medical Affairs

• Build a Network of KOLs Champions and design a long-term plan to nurture strong relationships to drive awareness and market adoption.
• Conduct medical advisory board meetings to gather expert insights, influencing company strategy and trajectory.
• Spearhead medical writing initiatives (white papers, abstracts, publications), conduct systematic literature reviews, and appraise clinical data to support product development and regulatory submissions.
• Facilitate post-market surveillance programs to monitor product performance and safety in real-world settings.
• Cultivate relationships with vascular societies to influence market perception and adoption, guidelines development, access to research collaborations, and presentations at major conferences.
• Initiate investigator-initiated studies (IIS) and clinical collaborations with academic institutions to expand the clinical evidence base and validate product efficacy.
• Support the regulatory affairs team with clinical documents as needed.

Reimbursement, Health Economics & Market Access

• Lead reimbursement, health economics and market access strategies and plans. Identify and navigate the various reimbursement pathways and secure coverage from payers and insurance providers.
• Conduct rigorous health economics research to demonstrate the value and cost-effectiveness of our products. Develop economic models and outcomes studies that highlight the benefits of our technology in terms of patient health outcomes, cost savings, and overall healthcare efficiency.
• Collaborate with strategic partners to expand their products’ claims and applications using our technology. This involves working together to identify unique value propositions and competitive advantages that can be leveraged to enhance the market appeal and technological attractiveness of our offerings.
• Conduct market research and analysis to identify emerging trends, unmet needs, and opportunities for differentiation. Use these insights to guide the development and expansion of product claims.
• Engage with key stakeholders, including healthcare providers, payers, regulators, and patient advocacy groups, to build support for our products. Communicate the value proposition and economic benefits to secure their endorsement and coverage.
• Develop and implement strategic plans to drive growth and profitability in the US market.
• Collaborate with R&D and Product teams to drive strategic initiatives and enhance product development to expand indications and product applications.

REQUIRED PROFILE

• Bachelor’s degree in a relevant field (e.g., Life Sciences, engineering etc.).
• 10 years’ experience in Clinical therapy development and scientific/medical affairs in the medical device industry in the vascular/cardiovascular/aortic field.
• Market access and reimbursement knowledge.
• A willingness to travel is a key requirement for this position.
• Ability to adapt to various time zones is crucial.
• East coast location ideally.