Director of Clinical Affairs

July 26

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Exactech

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Exactech is a global medical technology company that empowers orthopaedic surgeons with innovative implants, surgical instruments and the Active Intelligence® (AI) ecosystem of smart technologies to give patients EXACTLY what they need to regain mobility$1. .$1

Orthopaedic • Medical Device • Orthopedic • Implant • Surgical Instrumentation

501 - 1000

Description

• Responsible for providing leadership for the Clinical Affairs department in conducting effective clinical outcomes research to support clinical publications, presentations, and global registration approvals for Exactech products.

Requirements

• Assess clinical staffing needs and department organizational structure to align with current and future business objectives. • Lead the process of identifying, evaluating and approving clinical research projects in collaboration with business unit stakeholders that will leverage clinical research evidence to drive market share. • Provide knowledge and strategic planning support to the company’s business units, sales and marketing, engineering and regulatory departments related to clinical research. • Support clinical research, reporting, and analysis related regulatory submissions and compliance activities. • Lead the clinical research team, including daily operations, resource management, budgeting, and workload prioritization. • Develop and mentor clinical research personnel. • Oversee the planning, execution, and management of clinical research studies and activities including but not limited to: • Study design development and clinical protocols implementation • Study-site assistance with IRB process and documentation preparation • Investigator requirements, recruitment and contracts • Study-site budgetary needs • Compliance with applicable FDA, ISO, ICH/GCP and HIPAA requirements • Study monitoring • Data collection, processing and archiving/maintenance • Statistical analysis and interpretation of clinical data • Final reports • Support the identification, selection, and continuing management of external clinical support organizations (e.g. CROs, biostatistics support, etc). • Oversee the development of manuscripts, abstracts, book chapters, posters and in-house publications in cooperation with clinical investigators. Maintain a repository for these materials. • Oversee the development of annual regulatory and compliance reporting. • Stay current with orthopaedic and other relevant medical literature. • Develop / maintain relationships with surgeons and other professionals on issues related to Exactech’s research program and the field of orthopaedics. • Participate with other teams on product planning, design, development and marketing projects. • Establishes clearly defined department and individual goals. Responsible for hiring and terminations within the department as required. Identifies the training needs of the department and ensures that the appropriate training is obtained in a timely manner. • Provide team leadership for direct report(s) to include effective feedback on culture, results and future, coaching and mentoring, performance management and career development. • Know and apply Exactech’s Quality Management System and appropriate federal and international standards. • Support other employees, teams, and sales personnel as necessary.