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SENIOR DIRECTOR CLINICAL AFFAIRS
at ExacTech, inc.
Duties and Responsibilities (Key Deliverables):
1. 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.
2. Support clinical research related regulatory and compliance activities.
3. Lead the clinical research team, including daily operations, resource management, budgeting, and workload prioritization.
4. Develop and mentor clinical research personnel to create a best-in-class clinical research team.
5. Oversee the planning, execution, and management of all 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
6. Support the identification, selection, and continuing management of external clinical support organizations (e.g. CROs, biostatistics support, etc).
7. Oversee the development of manuscripts, abstracts, book chapters, posters and in-house publications in cooperation with clinical investigators. Maintain a repository for these materials.
8. Oversee the development of annual regulatory and compliance reporting.
9. Stay current with orthopaedic and other relevant medical literature.
10. Develop / maintain relationships with surgeons and other professionals on issues related to Exactech’s research program and the field of orthopaedics.
11. Participate with other teams on product planning, design, development and marketing projects.
12. Practice leadership as stated in the Exactech Leadership Model.
13. 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.
14. Provide team leadership for direct report(s) to include effective feedback on culture, results and future, coaching and mentoring, performance management and career development.
15. Know and apply Exactech’s Quality Management System and appropriate federal and international standards.
16. Support other employees, teams, and sales personnel as necessary.
Education: Bachelor’s Degree in a related field from an accredited institution required; Master’s Degree preferred
• 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