Director, Clinical Affairs and Medical Affairs Kelly® Science & Clinical is seeking a Director, Clinical Affairs and Medical Affairs for a direct-hire opportunity with our early-stage, innovation-driven Biotech client. If you’re passionate about advancing scientific discovery and ready to elevate your career, trust The Experts at Hiring Experts. Job Summary: The Director, Clinical Affairs and Medical Affairs will lead the development and execution of clinical evidence generation and scientific engagement throughout the product lifecycle. This critical leadership role drives scientific rigor, operational excellence, and alignment with regulatory and commercial objectives, serving as the clinical and medical lead in the organization. Key Responsibilities: Clinical Strategy & Study Execution: Lead strategies and execution for pre- and post-market clinical programs (including IDE studies, registries, and investigator-initiated studies). Design protocols, define endpoints, and align with regulatory/clinical practice expectations. Oversee trial execution, CROs, site selection, enrollment strategies, and ensure data quality. Manage study timelines, budgets, and program delivery. Clinical Evidence Generation: Interpret clinical data to support product development and lifecycle management. Lead development of abstracts, manuscripts, presentations, and scientific communications. Support benefit-risk assessments, indication expansion, and pipeline prioritization. Ensure clinical evidence meets regulatory, commercial, and market access goals. Medical Affairs & Scientific Engagement: Develop global medical affairs strategies for education, adoption, and evidence dissemination. Foster relationships with key opinion leaders, investigators, and partners. Lead advisory boards and scientific exchange initiatives. Cross-Functional & Organizational Leadership: Support teams with clinically accurate education and training. Align clinical strategy with new product development and global regulatory requirements. Collaborate on risk assessments, post-market surveillance, and evidence-based commercial strategies. Lead Clinical Affairs team members and manage departmental budgets, processes, and partnerships. Foster a culture of scientific rigor, accountability, and collaboration. Qualifications: Bachelor’s degree in life sciences, health sciences, clinical research, or related field (required). 7+ years of experience in clinical/medical affairs in the medical device industry. 5+ years’ leadership managing teams and complex clinical programs. Demonstrated success in leading pre- and post-market clinical studies. Experience with FDA and/or EU MDR regulatory environments. Preferred Qualifications: Advanced degree (MD, PhD, PharmD, or Master’s in clinical science/public health). Leadership in interventional, vascular, or image-guided therapies. Strong clinical study design and execution capabilities. Ability to translate clinical data into strategic decisions. Experience engaging physicians and developing KOL networks. Disciplined management of multi-site clinical programs and external partners. Effective communication and stakeholder management skills. FLSA Classification: Exempt Job Family: Director, AMD Reports To: Sr. VP, Medical Affairs & Medical Director Department: Clinical Research Physical Demands: Sedentary Travel: Up to 40% This job description does not cover all duties and responsibilities, which may change at any time. Our client maintains an employment-at-will relationship. #J-18808-Ljbffr
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