Key Responsibilities

Clinical strategy & execution
Define and develop the global clinical strategy, aligning with product development, regulatory milestones, and commercialization goals.
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.
Provide actionable insights to engineering, product, and leadership teams to feed into future product development.
Collaborate with regulatory affairs to ensure readiness for FDA and global submissions.
Build strong partnerships with surgeons, KOLs, and clinical sites, ensuring <10% problematic sites.
Lead publication and communication strategies to elevate visibility and credibility.
Build and mentor a world-class clinical team (>80% A players within two years)

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.

Relevant degree.
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.