Senior Director, Clinical Affairs

We believe that great healthcare is an essential safeguard of human dignity.At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you. We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We’re not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion. Who We’re Looking For:The Senior Director of Clinical is responsible for setting the clinical vision, leading clinical operations, and integrating clinical priorities into the company’s broader business strategy. This role demands a dynamic leader who can steer clinical innovation, navigate regulatory landscapes, and champion patient-centric outcomes while collaborating with the cross-functional teams to propel the company’s growth About the Role:

• Clinical Vision & Strategy: Define and execute a forward-thinking clinical strategy that aligns with the company’s mission, driving the development and commercialization of medical devices.
• Clinical Operations Oversight: Lead all clinical activities, including trial design, execution, and analysis ensuring scientific rigor, regulatory compliance, and operational efficiency.
• Regulatory Stewardship: Act as the primary clinical liaison with global regulatory authorities (e.g., FDA, EMA), lead responses to audits (external, internal, technical document, etc.) and ensuring successful outcomes.
• Team Leadership: Build and direct a high-performing clinical affairs organization, cultivating talent and fostering a culture of innovation, accountability, and excellence.
• Evidence & Impact: Spearhead the generation of clinical evidence through trials, real-world data, and peer-reviewed publications to substantiate device safety, efficacy, and value.
• Cross-Functional Partnership: Collaborate with R&D, regulatory, quality, and commercial teams to integrate clinical insights into product development, market entry, and lifecycle management.
• External Representation: Position the company as a clinical leader by engaging with key opinion leaders (KOLs), healthcare providers, industry groups, and at high-profile events.
• Risk & Compliance Management: Oversee clinical risk assessments, post-market surveillance, and adverse event reporting to uphold patient safety and regulatory standards.
• Financial Accountability: Manage the clinical affairs budget, optimizing investments to maximize clinical and business outcomes.

 Minimum Qualifications:

• Bachelor’s degree in a STEM field is required; an advanced degree (Master’s or Ph.D.) is strongly preferred.
• A minimum of 15 years of progressive clinical leadership experience within the medical device industry, including at least 10 years in a senior leadership capacity with demonstrated strategic and operational impact.
• Proven success in leading end-to-end clinical programs, from early-stage development through regulatory approval and commercial launch, across diverse therapeutic areas.
• Deep expertise in designing, executing, and overseeing large-scale, global, multi-center clinical trials, with a strong command of clinical operations and trial governance.
• Extensive experience in engaging with global regulatory authorities (e.g., FDA, EMA, PMDA), including leading regulatory submissions, audits, and advisory meetings with confidence and precision.
• Strong foundation in clinical protocol development, risk mitigation, and compliance with international standards such as GCP and ISO.
• Demonstrated ability to build and lead high-performing cross-functional teams, including Clinical Affairs, Regulatory, Medical Affairs, and R&D, fostering collaboration and accountability.
• Strategic leadership capabilities with a deep understanding of medical device development, clinical research methodologies, and global regulatory frameworks.
• Exceptional ability to influence and align diverse stakeholders, including executive leadership, external partners, and clinical investigators.
• Proven financial acumen, with experience managing multimilli