LinkedIn and 3rd parties use essential and non-essential cookies to provide, secure, analyze and improve our Services, and to show you relevant ads (including professional and job ads) on and off LinkedIn. Learn more in our Cookie Policy.
Select Accept to consent or Reject to decline non-essential cookies for this use. You can update your choices at any time in your settings.
The Director Clinical Affairs is 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.
Key Responsibilities
Establish the strategic vision for the clinical affairs department:
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.
Education
Skills Knowledge and Expertise
Bachelor's Degree in a related field from an accredited institution required; Master's Degree preferred
Experience
Minimum 10 years of clinical research experience required
Minimum 5 years of supervisory or management experience in clinical research required
Minimum 5 years of experience in FDA regulated device studies (IDE/PAS) and EU PMCF studies required
Knowledge of applicable federal and international regulations and guidelines (FDA, ISO, ICH/GCP, HIPAA, EU MEDDEV) required
Orthopaedic background and experience with total joint replacement studies and biologics material studies preferred
Functional/Technical Knowledge, Skills And Abilities Required
Well-developed verbal and written communication skills
Detail-oriented with strong organizational skills
Creative problem-solving and critical thinking skills
Flexibility and willingness to work with a variety of people
Strong technical writing skills
Familiarity with data acquisition platforms (EDC) and firm understanding of bio-statistical concepts (ability to use statistical software programs)
Working knowledge of MS Office database platforms, spreadsheets and graphical presentation programs
Seniority level
Director
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Medical Equipment Manufacturing
Referrals increase your chances of interviewing at Exactech by 2x