Director Clinical Affairs
Get AI-powered advice on this job and more exclusive features.Direct message the job poster from Skills AllianceJob Title: Director, Clinical AffairsLocation: USA (Flexible – preference for major neurovascular hubs)Department: Clinical AffairsReports to: Vice President, Clinical AffairsAbout UsWe are a rapidly growing medical device company pioneering advanced interventional neurovascular therapies for the treatment of complex cerebrovascular diseases, including ischemic stroke, aneurysms, and other neurovascular disorders. Our mission is to develop devices that transform patient outcomes and set new standards of care.Position SummaryThe Director of Clinical Affairs will be responsible for leading the planning, execution, and management of clinical programs that support regulatory submissions, product launches, and post-market data collection. This role requires strong leadership in clinical trial operations, investigator engagement, and cross-functional collaboration.The ideal candidate will have direct experience running neurovascular or complex endovascular clinical studies and be comfortable operating in a high-growth, fast-paced environment.Key ResponsibilitiesLead the design, planning, and execution of assigned clinical trials (feasibility, pivotal, and post-market) in accordance with regulatory and ethical standards.Manage day-to-day trial operations, including site selection, initiation, monitoring, data collection, and close-out.Partner with the VP of Clinical Affairs to develop global clinical strategies and timelines.Build strong relationships with KOLs, principal investigators, and study coordinators to drive enrollment and study success.Oversee CROs, vendors, and internal clinical staff to ensure high-quality execution and deliverables.Ensure compliance with GCP, ISO 14155, FDA, and other applicable regulations.Provide clinical insights to R&D, Regulatory Affairs, and Marketing for product development and physician training programs.Support the preparation of clinical sections for regulatory submissions and peer-reviewed publications.Represent the company at investigator meetings, scientific conferences, and training events.QualificationsBachelor’s degree in life sciences, nursing, biomedical engineering, or related field (advanced degree preferred).8+ years of clinical research or clinical affairs experience in the medical device industry, with at least 3 years in a leadership role.Proven track record of working with U.S. and OUS regulatory bodies.Strong organizational, communication, and leadership skills.Willingness to travel domestically and internationally (approx. 30%).What We OfferCompetitive compensation package with performance-based bonus and equity opportunities.The opportunity to directly impact the success of groundbreaking neurovascular devices.A collaborative, mission-driven team environment.Seniority levelSeniority levelNot ApplicableEmployment typeEmployment typeFull-timeJob functionJob functionOtherIndustriesMedical Equipment ManufacturingReferrals increase your chances of interviewing at Skills Alliance by 2xSign in to set job alerts for “Director Clinical Affairs” roles.United States $200,000.00-$240,000.00 1 week agoDirector of Clinical Research ConsultingChicago, IL $130,000.00-$160,000.00 2 months agoDirector, Clinical Operations (Medical Affairs)United States $204,000.00-$255,000.00 1 week agoUnited States $200,000.00-$230,000.00 1 week agoExecutive Director, Therapeutic Strategy Lead - Metabolic - US/Europe - RemoteUnited States $229,581.00-$275,494.00 1 week agoDirector, Clinical and Translational DevelopmentExecutive Director Clinical Development - Breast CancerNew Jersey, United States $380,000.00-$410,000.00 3 weeks agoUnited States $230,000.00-$250,000.00 1 month agoSenior/Executive Medical Director, Clinical DevelopmentUnited States $310,000.00-$380,000.00 5 days agoUnited States $300,000.00-$380,000.00 5 days agoUnited States $200,000.00-$300,000.00 1 day agoPhiladelphia, PA $196,000.00-$294,000.00 2 weeks agoDirector, Non-Clinical Business DevelopmentUnited States $160,000.00-$180,000.00 1 month agoUnited States $270,000.00-$310,000.00 1 hour agoDirector Field Medical Affairs, NephrologyUnited States $221,000.00-$271,000.00 5 days agoExecutive Medical Director, US Medical Affairs LeadSenior Director, Clinical Value & Access, ScreeningUnited States $264,400.00-$363,550.00 4 days agoMedical Affairs Director, Screening (Clinical Education)United States $200,800.00-$276,100.00 4 days agoDirector/Senior Director, Medical Affairs - MidwestDirector/Senior Director, Scientific AffairsUnited States $210,000.00-$240,000.00 1 day agoUnited States $171,000.00-$239,667.00 4 days agoUnited States $220,000.00-$297,000.00 1 week agoSenior Regional Director, Medical Science Liaisons - WestUnited States $215,000.00-$280,000.00 2 weeks agoDirector, Field Medical Affairs (Auditory/Gene Therapy)We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr