Note: The job is a remote job and is open to candidates in USA. CONMED Corporation is a leading medical technology company, and they are seeking a Senior Director of Clinical Affairs to lead the development of the clinical strategy for the Advanced Surgical portfolio. This role involves overseeing clinical trials, ensuring regulatory compliance, and engaging with key stakeholders to support evidence generation and market adoption.
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
Skills
- 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
- 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
- Advanced degree in Life Sciences, Medicine, or related field (MD, PhD, or equivalent preferred)
Benefits
- Competitive compensation
- Excellent healthcare including medical, dental, vision and prescription coverage
- Short & long term disability plus life insurance -- cost paid fully by CONMED
- Retirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period
- Employee Stock Purchase Plan -- allows stock purchases at discounted price
- Tuition assistance for undergraduate and graduate level courses
Company Overview
CONMED is a global medical technology company that specializes in the development and sale of surgical and patient monitoring products and services that allow our physician customers to deliver high quality care and as a result, enhanced clinical outcomes for their patients. It was founded in 1970, and is headquartered in Utica, New York, USA, with a workforce of 1001-5000 employees. Its website is http://www.conmed.com/.