Vice President Clinical Development

Position Overview

INSIGHTEC is a growing medical technology company transforming patient lives through innovative incisionless surgery.

Our culture is diverse and global, driven by our core values – Our Patients, Integrity, Team, Quality and Innovation. We strive for a life-work balance and a flexible work environment that enables meaningful work.

The VP of Clinical Affairs will ensure that clinical programs are resourced and managed to fulfil all regulatory guidelines, compliance and ethical principles for medical research and drive operational excellence. This role involves strategic planning, execution, and oversight of all trial-related activities, ensuring compliance, and driving efficiency throughout the clinical development process. Will also lead development and implementation of department policies as well as maintain awareness of the global regulatory environment and assess and communicate impact of changes on business and product development programs. As team leader, the VP Clinical Affairs will ensure his/her team works efficiently with internal and external stakeholders, they understand company’s objectives and are able to articulate how their work contributes to it.

• Serve as a key advisor to the CMO and the Executive Team, working collaboratively with Regulatory Affairs and QA, as well as with Engineering research team and other internal business partners.
• Lead and mentor the clinical research organization fostering a collaborative and high performing team.

Responsibilities

• Manage all clinical development aspects of INSIGHTEC'S products, including applications submitted to regulatory agencies such as FDA/CE/AMAR etc.
• Ensure adherence to all relevant regulations, including FDA guidelines, ICH guidelines, and GCP standards.
• Development of effective clinical research strategies and tactical execution of research activities for product lifecycle management including product development, commercialization, and post-marketing.
• In collaboration with Regulatory Affairs, contribute on regulatory submissions and reports for Medical device Class III products. This includes submission and report types for products approved/cleared through PMA, and 510(k) pathways and technical files for EU and Asia.
• Ensure that Clinical Study reports submissions are complete, properly formatted, and comply with applicable regulatory requirements.
• Manage all aspects of clinical trial execution, from study startup to closeout, ensuring adherence to timelines, budgets, and quality standards. Once completed, studies are properly closed in a timely manner.
• Interact with government agencies, regulatory bodies and officials, as necessary, to facilitate submission review and product approvals, maintain compliance and communicate pertinent information.
• Participate in cross-functional teams and activities such as product design and development, risk assessments, evaluation of quality events and non-conformances, evaluation of change controls, validation and testing; determine impact on submissions and filing requirements.
• Collaborate with Quality Systems to manage and maintain compliance of systems and processes with QSR requirements, applicable international requirements and industry standards, including support of on-site audits both internal and external.
• Implement and maintain quality assurance processes to ensure the integrity and reliability of clinical trial data. Ensure all clinical research documentation is properly handled and follow Insightec’s QA guidance for documentation handling.
• Develop and manage clinical trial budgets, ensuring cost-effectiveness and efficient resource utilization.
• Provide regular updates and communication to senior management, stakeholders, and other relevant parties on trial progress, risks, and issues.
• Monitor, identify and communicate new and relevant changes in applicable regulations, guidance, standards, and other applicable regulatory policies.
• Interact with outside consulting groups and vendors to manage activities necessary for completing key initiatives.
• Provide mentoring and development opportunities to team members fostering a collaborative and high performing team.

Qualifications

• Advanced degree in life sciences or related scientific discipline (MS, PhD, MD) is required.
• 10+ or more years of experience in Clinical Research design and execution within the pharmaceutical, biotech, and/or medical device industry.
• Strong knowledge of clinical research principles, GCP guidelines, FDA regulations, and other relevant regulatory requirements.
• Proven track record of managing and leading clinical trials, conducting medical review, clinical study reports and safety updates.
• Must have experience with all phases of clinical development including post-approval.
• Experience in submission of regulatory filings to the appropriate entities and interactions with these agencies.
• Excellent leadership, communication, and interpersonal skills, as well as strong analytical and problem-solving abilities.
• Experience with budget management, vendor management, and quality assurance processes is essential.

Other Requirements

• Ability to travel internationally is required

Seniority level

• Executive

Employment type

• Full-time

Job function

• Research, Health Care Provider, and Science

Industries

• Medical Device, Biotechnology Research, and Pharmaceutical Manufacturing