
Senior Director, Clinical Affairs
CONMED Corporation
full-time
Posted on:
Location Type: Remote
Location: Colorado • United States
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Salary
💰 $199,100 - $308,500 per year
Job Level
Tech Stack
About the role
- Lead the development of the overall clinical strategy for Advanced Surgical (AS) portfolio
- Design and oversee clinical trials that support regulatory approvals, market adoption, and post-market surveillance
- 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
- Build relationships with surgeons, hospital systems, and Key Opinion Leaders (KOLs)
- Lead and mentor team of clinical and data leaders
Requirements
- Advanced degree in Life Sciences, Medicine, or related field (MD, PhD, or equivalent preferred)
- 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
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial designbiostatisticsregulatory complianceclinical evidence generationregulatory submissionssurgical technologiesproject managementdata analysisprotocol developmentrisk assessments
Soft Skills
leadershipcommunicationstrategic planningcollaborationrelationship buildingmentoringteam managementproblem-solvinginterpersonal skillsadaptability
Certifications
MDPhDadvanced degree in Life Sciencesadvanced degree in Medicine