Senior Director, Clinical Affairs

Senior Director Of Clinical Affairs

The Senior Director of Clinical Affairs will lead the development of the overall clinical strategy for Advanced Surgical (AS) portfolio, with a focus on AirSeal. This leader will be a critical voice on the AS Leadership team and will support the execution of evidence generation based on the clinical strategy, in partnership with broader ConMed organization. This role is responsible for designing and overseeing clinical trials that support regulatory approvals, market adoption, and post-market surveillance; additionally, the role will support broader KOL mapping and engagement, in partnership with marketing organization. The ideal candidate brings deep expertise in surgical environments, strong leadership, and a proven track record in clinical development within the medical device industry.

Key Responsibilities

• Develop and implement clinical development plans for surgical devices, including laparoscopic, robotic-assisted, and open surgery technologies.
• Design and oversee clinical trials that demonstrate safety, efficacy, and real-world performance.
• Collaborate with R&D, Regulatory, and Marketing to align clinical strategy with product innovation and commercialization.
• Partner with ConMed Center of Excellence on protocol development, site selection, investigator engagement, and trial monitoring.
• Ensure compliance with GCP, FDA, and international regulatory standards.
• Manage CROs, clinical sites, and vendors to ensure timely and high-quality trial execution.
• Generate clinical evidence to support regulatory submissions (e.g., IDE, 510(k), PMA, CE Mark).
• Provide clinical input for labeling, risk assessments, and health economics studies.
• Support interactions with regulatory bodies and contribute to submission documentation.
• Build relationships with surgeons, hospital systems, and Key Opinion Leaders (KOLs).
• Develop and execute publication plan; oversee clinical data presentations at surgical congresses and publication in peer-reviewed journals.
• Collaborate with Marketing and Medical Affairs to translate clinical insights into strategic messaging.
• Lead and mentor team of clinical and data leaders.
• Foster a culture of scientific excellence, operational efficiency, and cross-functional collaboration.

Qualifications

• Education:

  • Advanced degree in Life Sciences, Medicine, or related field (MD, PhD, or equivalent preferred).

• Experience:

  • 10+ years in clinical development within the medical device industry, with a focus on surgical technologies.
  • Demonstrated success in leading clinical trials and regulatory submissions.
  • Proven leadership managing third party vendors from selection through execution of MSAs (e.g. CROs, EDC, etc.)
  • Experience working with global regulatory agencies and surgical stakeholders.

• Skills:

  • Deep understanding of surgical workflows and clinical endpoints.
  • Strong leadership, communication, and strategic planning abilities.
  • Expertise in clinical trial design, biostatistics, and regulatory compliance.
  • Ability to manage complex projects and cross-functional teams.