Position Summary:
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:
Clinical Strategy & Trial Design
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.
Trial Execution & Oversight
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.
Evidence Generation & Regulatory Support
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.
Stakeholder Engagement
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.
Leadership & Team Development
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.
This job posting is anticipated to close on March 16 2026. We may however extend this time period in which case the posting will remain available on . Please submit your application as soon as possible as we will be reviewing applications on a rolling basis as we receive them.
This position is not eligible for employer-based sponsorship.
Disclosure as required by applicablelaw the annual salary range for this position is $199100 to $308500. The actual compensation may vary based on geographic location work experience education and skill level. The salary range is CONMEDs good faith belief at the time of this posting.
Coloradoresidents: In any materials you submit you may redact or remove age identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Benefits:
CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information.
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CONMED is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic. Protected veterans and individuals with disabilities are encouraged to apply. The Know Your Rights: Workplace Discrimination is Illegal Poster reaffirms this commitment.
Colorado Residents: In any materials you submit you may redact or remove age-identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
If you feel you need a reasonable accommodation pursuant to the ADA you are encouraged to contact us at option #5.
Required Experience:
Exec
As a leading surgical device manufacturer, CONMED strives to empowers healthcare providers to deliver exceptional patient outcomes worldwide.