[Remote] Senior Director, Clinical Affairs

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.ResponsibilitiesDevelop and implement clinical development plans for surgical devices, including laparoscopic, robotic-assisted, and open surgery technologiesDesign and oversee clinical trials that demonstrate safety, efficacy, and real-world performanceCollaborate with R&D, Regulatory, and Marketing to align clinical strategy with product innovation and commercializationPartner with ConMed Center of Excellence on protocol development, site selection, investigator engagement, and trial monitoringEnsure compliance with GCP, FDA, and international regulatory standardsManage CROs, clinical sites, and vendors to ensure timely and high-quality trial executionGenerate clinical evidence to support regulatory submissions (e.g., IDE, 510(k), PMA, CE Mark)Provide clinical input for labeling, risk assessments, and health economics studiesSupport interactions with regulatory bodies and contribute to submission documentationBuild 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 journalsCollaborate with Marketing and Medical Affairs to translate clinical insights into strategic messagingLead and mentor team of clinical and data leadersFoster a culture of scientific excellence, operational efficiency, and cross-functional collaborationSkills10+ years in clinical development within the medical device industry, with a focus on surgical technologiesDemonstrated success in leading clinical trials and regulatory submissionsProven leadership managing third party vendors from selection through execution of MSAs (e.g. CROs, EDC, etc.)Experience working with global regulatory agencies and surgical stakeholdersDeep understanding of surgical workflows and clinical endpointsStrong leadership, communication, and strategic planning abilitiesExpertise in clinical trial design, biostatistics, and regulatory complianceAbility to manage complex projects and cross-functional teamsAdvanced degree in Life Sciences, Medicine, or related field (MD, PhD, or equivalent preferred)BenefitsCompetitive compensationExcellent healthcare including medical, dental, vision and prescription coverageShort & long term disability plus life insurance -- cost paid fully by CONMEDRetirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay periodEmployee Stock Purchase Plan -- allows stock purchases at discounted priceTuition assistance for undergraduate and graduate level coursesCompany OverviewCONMED 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/.