Senior Director, Clinical Affairs jobs in United States
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CONMED Corporation · 23 hours ago

Senior Director, Clinical Affairs

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.

Information TechnologyMedicalMedical Device
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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

Qualification

Clinical trial designRegulatory complianceSurgical technologiesStrategic planningLeadershipBiostatisticsClinical endpointsCommunicationProject management

Required

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

Preferred

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

CONMED Corporation

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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.

Funding

Current Stage
Public Company
Total Funding
$700M
2022-05-31Post Ipo Debt· $700M
2012-07-16Acquired
2003-01-01Post Ipo Equity

Leadership Team

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Patrick Beyer
Chief Executive Officer
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Todd Garner
EVP, CFO
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Company data provided by crunchbase