Vice President of Clinical

ACE Partners are working with an FDA Breakthrough Start-up looking for a Vice President of Clinical to join their Executive team and lead the Clinical Strategy & Operations.

The Vice President of Clinical will be a key member of the executive team, responsible for overseeing all clinical research activities, including the initiation and management of pivotal and feasibility studies.

This role requires a strategic leader with extensive hands-on experience in clinical development, managing Clinical Research Organizations (CROs), and driving clinical programs.

Key Responsibilities:

• Develop and implement the clinical strategy for the company's medical device portfolio (CANCER)
• Lead the design, initiation, and execution of pivotal and feasibility clinical studies to support regulatory submissions and market access.
• Oversee the selection, management, and performance of CROs and other clinical vendors to ensure timely and high-quality delivery of clinical trials.
• Collaborate with regulatory, R&D, marketing, and other internal teams to align clinical development plans with corporate objectives.
• Provide clinical expertise and guidance to the executive team, contributing to strategic decision-making and business planning.
• Ensure compliance with all relevant regulatory requirements, including FDA, EMA, and other international regulatory bodies.
• Develop and manage the clinical budget, ensuring efficient allocation of resources.
• Establish and maintain relationships with key opinion leaders, clinical investigators, and other stakeholders in the medical and scientific community.
• Present clinical findings and updates to internal and external stakeholders, including the board of directors, investors, and regulatory agencies.

Qualifications:

• Advanced degree in a scientific or medical discipline (MD, PhD, or equivalent preferred).
• Minimum of 10 years of experience in clinical research and development, with a focus on medical devices.
• Proven track record of successfully initiating and managing pivotal and feasibility studies.
• Extensive experience managing CROs and external clinical vendors.
• Strong understanding of regulatory requirements and clinical trial design.
• Demonstrated ability to work effectively as part of an executive team, with strong leadership and communication skills.
• Strategic thinker with the ability to translate vision into actionable plans.
• Ability to thrive in a fast-paced, start-up environment.

Competitive Salary & Equity with this role