Our client is developing next-generation robotic surgical technology that leverages AI and automation to improve clinical outcomes and efficiency. They are initially focused within a specific surgical area, with a broader vision of expanding into a multi-application platform that can play a central role in the operating room.

As a technology-driven healthcare company, they take a software-first approach, enabling rapid iteration cycles and a strong emphasis on data-driven development. Clinical data is a key input into their product strategy, with continuous feedback loops helping to refine and improve performance over time.

They are seeking a Head of Clinical to lead clinical strategy across product development, adoption, and regulatory efforts. This role is ideal for someone who thrives in fast-paced environments and can translate clinical insights into clear direction for both product and commercial strategy.

Key Responsibilities

Clinical strategy & execution:

• Define and develop the global clinical strategy, ensuring alignment with product development, regulatory milestones, and commercialization needs.
• Oversee clinical trials, registries, and real-world evidence programs that serve two key purposes: 1) collect data for product development, and 2) demonstrate safety, efficacy, and clinical value for regulatory clearance and adoption.
• Ensure >80% of studies meet company requirements and >90% enrollment targets are achieved.

Working across departments

• Provide actionable insights to engineering, product, and leadership teams that directly improve the surgical platform.
• Collaborate with regulatory affairs to ensure readiness for FDA and global submissions.
• Managing stakeholders
• Build strong partnerships with surgeons, KOLs, and clinical sites, ensuring <10% problematic sites.
• Lead publication, conference, and communication strategies to elevate visibility and credibility.

Team building

• Build and mentor a world-class clinical team (>80% A players within two years).
• Foster a culture of accountability, resourcefulness, and outcome-driven execution.

Ideal Candidate Profile

• Extensive experience in clinical strategy, clinical operations, or clinical affairs, ideally within techmed, surgical robotics, or software as a medical device.
• Demonstrated success in driving clinical studies from design to successful completion, including both pre- and post-market studies.
• Track record of working with FDA and international regulatory bodies on submissions and approvals.
• Skilled in bridging clinical, engineering, regulatory, and commercial teams to ensure aligned decision-making.
• Strong communicator with ability to translate data into strategic insights for both technical and non-technical audiences.
• Relentlessly resourceful, able to find unconventional solutions to problems.

Qualifications

• Degree in life science, medicine, or related discipline.
• Deep knowledge of Good Clinical Practice (GCP), ISO 14155, and relevant clinical/regulatory frameworks.
• Expertise in study design, evidence generation, and data governance.
• Experience building and scaling clinical programs in high-growth startups.
• Experience in surgical robotics or AI surgical tools preferred.