Director, Clinical Affairs

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

Our culture is as unique as our people, a diverse global team, with different ideas, skills, interests, and cultural backgrounds driven by our core values – Our Patients, Integrity, Team, Quality and Innovation.

Our dedication to making a real impact on the lives of millions of people and paving the path to a bright future for healthcare, is what bonds us as a Team. We work together in a dynamic collaborative environment to deliver successfully while believing and driving a life-work balance philosophy that encourages our employees to do things that are meaningful outside of work. Every role is significant, your voice is heard, and your ideas are encouraged. We challenge and empower our people to be great at what they do while providing a flexible work environment.

Walking through our corridors, you will be inspired by stories of career journeys at Insightec. We take pride in growing internal talent and encourage our employees to achieve their professional ambitions. With employees in Israel - Haifa and K. Ono, Miami and Dallas, Shanghai, Tokyo and Europe, we offer in each region competitive perks and benefits.

Do the most meaningful work of your career by joining us on our mission to transform tomorrows, today.

Position Summary:

The Director of Clinical Affairs will provide strategic leadership and oversight of global clinical development programs across multiple therapy platforms and geographies. This individual will serve as the clinical research authority within cross-functional and global teams, driving the successful execution of clinical strategies that support regulatory approvals, commercialization, and long-term growth. The Director will be accountable for building and scaling organizational capabilities to conduct clinical programs under their responsibility, mentoring high-performing teams, and shaping the company's global clinical affairs vision.

Key Responsibilities:

Strategic Leadership & Clinical Expertise

• Act as the senior clinical subject matter expert, working cross-functionally with Medical Affairs providing input into clinical trial design, serving as the accountable manager for program execution and timely study closures, and regulatory strategies across diverse indications.
• Develop, lead, and execute multi-year clinical strategy aligned with business and regulatory objectives.
• Provide expert consultation to the CMO and VP, Clinical Affairs as well as to executive leadership, regulatory bodies, and external stakeholders on clinical evidence and data-driven decisions.

Clinical Program Oversight

• Direct global clinical programs from feasibility through pivotal trials, ensuring excellence in design, execution, data integrity, and compliance.
• Oversee study strategy, scope, processes, budgets, timelines, and outcomes at the portfolio level. Prepare and update clinical dashboards summarizing study progress.  Design study recruitment plans including social media, website portals, and other methods.
• Ensure alignment of clinical evidence strategy with regulatory submission needs (FDA, EMA, PMDA, and other global health authorities).
• Champion innovation in trial design (adaptive trials, digital health technologies, real-world evidence).

Regulatory & Compliance Leadership

• Serve as a senior point of contact with domestic and international regulatory agencies, leading high-level interactions and negotiations.
• Provide strategic oversight for the preparation of clinical sections of PMA, 510(k), NDA, IDE, IND, and international submissions.
• Ensure compliance with GCP, ISO, and global medical device/drug regulatory requirements.

Stakeholder & Relationship Management

• Build and sustain long-term relationships with Key Opinion Leaders (KOLs), investigators, clinical research organizations (CROs), and strategic partners.
• Represent the company at scientific and medical forums, enhancing visibility and credibility within the clinical and regulatory community.
• Collaborate with internal executive leadership to align clinical evidence with commercial, medical affairs, and R&D priorities.

Team Leadership & Organizational Development

• Lead, mentor, and develop a high-performing Clinical Affairs team, driving talent development, succession planning, and culture of excellence.
• Establish and continuously improve operational infrastructure to support efficiency, scalability, and quality in global clinical execution.
• Oversee vendor partnerships and performance (statistical consultants, CROs, labs, DSMBs).

Preferred Qualifications:

• 10+ years of progressive experience in clinical research development, expertise in clinical trial strategy within medical device, drug-device combination, or pharmaceutical industries including execution, and regulatory submissions (Class III devices, IDEs/INDs, global pivotal trials).
• Minimum of 5 years of experience in drug development studies including submissions to FDA.
• Solid track record in successfully designing and executing Phase I – III clinical trials.
• Background in Oncology/Neuro-Oncology or Neuro-functional preferred
• Strong track record of successful interactions with FDA and OUS (FDA, ISO, ICH/GCP, HIPAA, EU MEDDEV) regulatory agencies, including leading responses to complex regulatory questions.
• Experience leading the writing of protocols, investigator brochures, clinical study reports, and manuscripts.
• Proven ability to translate clinical data into regulatory and commercial claims and outcomes.
• Exceptional communication and presentation skills with experience engaging executive leadership, regulatory authorities, and scientific audiences.
• Demonstrated success in building, scaling, and leading high-performance teams. Minimum of five years of direct line management experience.