Director Clinical Research

Develop and execute a multi-year clinical research strategy aligned with organizational objectives. Establish annual research goals, performance metrics, and growth initiatives. Identify emerging trends and opportunities within spine surgery, orthopedic surgery, biologics, robotics, navigation technologies, and medical devices. Build and maintain strategic partnerships with academic centers, industry sponsors, CROs, and key opinion leaders. Lead efforts to expand the organization's research portfolio and clinical trial pipeline. Direct all phases of clinical research studies, including feasibility assessments, protocol implementation, patient recruitment, data collection, monitoring, and study closeout. Oversee a portfolio of industry-sponsored, investigator-initiated, and multicenter clinical studies. Ensure research projects are completed on time, within budget, and according to protocol requirements. Develop and implement SOPs to improve efficiency, quality, and compliance. Monitor study enrollment, retention, and performance metrics. Ensure compliance with FDA regulations, Good Clinical Practice (GCP), HIPAA, IRB requirements, and applicable federal, state, and institutional guidelines. Maintain readiness for sponsor audits, FDA inspections, and regulatory reviews. Oversee adverse event reporting, protocol deviations, and corrective action plans. Establish quality assurance and quality improvement initiatives for research operations. Collaborate with spine and orthopedic surgeons to identify clinically relevant research opportunities. Provide guidance on study design, protocol development, statistical methodologies, and publication strategies. Support manuscript preparation, abstracts, presentations, and peer-reviewed publications. Promote dissemination of research findings at national and international scientific meetings. Foster a culture of inquiry, innovation, and evidence-based practice. Develop and manage departmental budgets, research revenue forecasts, and study-related financial plans. Lead sponsor contract negotiations and clinical trial budgeting activities. Ensure accurate financial tracking, invoicing, and reimbursement for research activities. Identify funding opportunities through grants, foundations, and industry partnerships. Recruit, mentor, and develop research coordinators, managers, data specialists, and research staff. Establish performance objectives and professional development plans. Foster a collaborative and high-performing research environment. Serve as a trusted advisor to physicians, executives, and operational leaders. Qualifications Master's degree in Clinical Research, Public Health, Healthcare Administration, Life Sciences, Nursing, or related field. Advanced degree (PhD, MD, DO, PharmD, or equivalent) preferred. 10+ years of progressive clinical research experience. 5+ years of leadership experience managing clinical research programs and teams. Significant experience in spine surgery, orthopedic surgery, musculoskeletal medicine, medical devices, or related clinical specialties. Demonstrated success managing industry-sponsored and investigator-initiated studies. Experience with multicenter clinical trials and registry-based research. Certified Clinical Research Professional (CCRP) Certified Clinical Research Coordinator (CCRC) Clinical Research Associate Certification (CCRA) Good Clinical Practice (GCP) Training Deep understanding of orthopedic and spine surgery procedures, technologies, implants, and outcomes research. Advanced knowledge of FDA regulations, IRB processes, GCP standards, and human subject protections. Strong clinical trial design, biostatistics, and scientific writing capabilities. Proven ability to develop high-performing research teams. Excellent project management and organizational skills. Strong financial acumen related to clinical trial budgeting and contract negotiations. Exceptional communication and stakeholder management skills. Proficiency with electronic data capture systems, CTMS platforms, REDCap, and statistical software. Preferred Qualifications Spine implants and instrumentation Orthopedic trauma, sports medicine, joint reconstruction, or deformity correction Robotic-assisted spine or orthopedic surgery Medical device clinical trials FDA IDE and post-market surveillance studies Outcomes research and patient-reported outcome measures (PROMs) #J-18808-Ljbffr RedBrick Staffing