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Haemonetics Corporation Sr. Medical Director, Hospital in Denver, Colorado

We are constantly looking to add to our core talent. If you are seeking acareer that is challenging and rewarding, a work environment that is diverseand dynamic, look no further - Haemonetics is your employer of choice.Job DetailsProvide medical advice and oversight to the portfolio of clinical developmentprojects for Hospital products with focus on Vascade (Class III, vascularclosure device) as well as TEG and ClotPro (IVD), as well as tomedical safety assessments for this portfolioDesign medical strategy and clinical development plans for key products andprojects in close coordination with cross-functional partners (e.g.,Clinical Development, Medical Affairs, R&D, Marketing, Regulatory,Clinical Quality); author (as needed) and review/approve clinicalprotocols and reports, support documentation for regulatory submissions andfilProvide medical oversight of clinical trial execution, conduct requiredmedical monitoring, and work with sites as well as third party providers,such as CROs, statisticians, etc., as needed and in partnership withClinical Development and Medical Affairs.Author (as needed) and/or review/approve statistical analysis plans;review and contribute to interpretation of clinical trial data; conduct(as needed) and/or review/approve statistical analyses; author (asneeded) and/or review/approve Clinical Study Reports (CSR)Present clinical plans, protocols, results etc. to U.S. FDA or otherregulatory authorities, as requiredRepresent the Hospital portfolio externally related to new product innovation(NPI) and Clinical DevelopmentSupport Clinical Development in building a reliable network of high-qualitysites and investigators (focus on cardiology, interventional cardiology,electrophysiology)Actively engage with the clinical and scientific community to gain insightsinto our products and their potential use to inform clinical trial design;conduct advisory board meetings as neededRepresent clinical development programs at national and internationalscientific conferences, as appropriateCollaborate closely with the business to align priorities, develop projectconcepts and to quantify opportunitiesEnsure compliance of Haemonetics clinical development efforts with allapplicable regulationsRequirementsEducation:Bachelor's Degree preferably B.S.Master's Degree preferably in life sciencesAdvanced degree M.D. (preferred) or Ph.D. in life sciences requiredExperience:10 years minimum Clinical and academic experience in relevant roles required(someone that has practiced medicine in the area and made the transitioninto the industry)5 years minimum (additional) Industry experience in Medical/Clinicalleadership roles requiredIndustry experience Medical Devices or Pharma preferredIndustry experience In vitro diagnostics (IVD) or Vascular Closure preferredTherapeutic area experience Coagulation, Cardiology, InterventionalCardiology, Electrophysiology preferredTravel:30% Travel (including overnight, primarily domestic US travel)Conditions of Employment:Haemonetics' policy requires COVID-19 vaccinationfor all U.S. employees,unless approved for a medical, religious orbusiness exemption.While we recognize employees have their own individualbeliefs and perspectives regarding vaccination, we believe it is animportant step as part of our obligation to protect our colleagues, ourcustomers and our communities as we continue to make health and safety our topHaemonetics is an equal opportunity employer. In accordance with applicablelaw, we prohibit discrimination against any applicant or employee based onany legally-recognized basis, including, but not limited to: race,color, religion, sex (including pregnancy, lactation, childbirth orrelated medical conditions), sexual orientation, gender identity, age(40 and over), national origin or ancestry,physical or mental disability, genetic information (including testing andcharacteristics), veteran status, uniformed service member status or anyother status protected by federal, state or local law ("Pr