Director of Clinical Affairs

Job Type Full-timeDescriptionThe Director of Clinical Affairs is responsible for all clinical aspects of medical device development projects at all stages of the product life cycle, for clinical affairs activities, and for special projects. This full-time role reports to the Vice President of Regulatory, Quality and Clinical Affaris and is located in the Minneapolis, Minnesota, office.Essential FunctionsSelect Clinical consultants and Clinical Research Organizations (CROs) and manage their contractsRecruit, hire, train, manage and facilitate the career development of Clinical staff Prepare and track the company's Clinical trials budget on an annual basisAllocate resources and budgets to various department projects and oversee their progressParticipate in preparation of Clinical operating plans and objectives in alignment with company and department strategiesSupervise the implementation of clinical programs and track their progressOversee the planning of new clinical programs and the development of clinical protocolsReview and approve submissions of protocols and reports to the relevant regulatory authorities and Institutional Review Boards (IRBs) or Ethics Committees (ECs)Interact with Investigators and IRBs on financial and compliance issuesOversee the proper collection, analysis and presentation of clinical dataReview and approve final Case Report Forms, Edit Checks and Clinical Study DatabasesOversee development and maintenance of department standard operating procedures (SOPs)Assure compliance of department activities to the relevant regulations, department SOPs and corporate requirementsDevelop and manage the process for clinical regulatory document preparation and submissions for clinical studies (IDE submissions, IRBEC submissions, etc.)Other tasks and responsibilities as assignedAnticipated travel: 10-20%RequirementsCompetencies Strong knowledge of FDA regulations and International Conference Harmonization (ICH) and Good Clinical Practices (GCPs) guidelinesDemonstrated experience with European clinical study requirements and CE marking, EUMDD MDR, MEDDEV 2.7.1 Revision 4, ISO 14155 and other relevant regulationRegulatoryClinical document writingAbility to independently lead clinical researchHigh interpersonal skillsFluency in EnglishExcellent teamwork skillsStrategic thinkingPresentation skillsLeadership skillsEducation & Experience Master's degree in science or health-related field8+ years of experience in the medical device required, with a portion of that being in a MedicalClinical Affairs role6+ years of experience in laboratory, preclinical and Clinical Research roles requiredLeadership or people management experience is an assetThis job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time. Kerecis is an equal opportunity employer. #LI-KER

Created: 2025-02-19