Position Overview:
The Chief Medical Officer (CMO) is a key member of the Executive Leadership Team responsible for providing strategic and operational leadership for the Company's global Medical Affairs and Clinical Affairs functions. The CMO serves as the organization's senior medical leader, driving the clinical and scientific strategy that supports product development, regulatory approvals, commercialization, and lifecycle management of the Company's innovative spine and extremities portfolio.
The CMO partners closely with Research & Development, Regulatory Affairs, Quality, Commercial, Marketing, and Executive Leadership to ensure clinical evidence generation, physician engagement, and medical strategy are aligned with the Company's business objectives while maintaining the highest standards of patient safety, scientific integrity, and regulatory compliance.
Key Responsibilities
Executive Leadership
- Serve as a member of the Executive Leadership Team, contributing to corporate strategy and long-term business planning.
- Develop and execute the Company's global medical and clinical strategy aligned with organizational objectives.
- Provide expert medical guidance to the CEO, Board of Directors, and ELT.
- Represent the Company with physicians, key opinion leaders (KOLs), scientific societies, regulatory agencies, investors, and strategic partners.
- Foster a culture of scientific excellence, innovation, and patient-centered decision making.
Clinical Affairs
- Establish the overall clinical development strategy for new and existing products.
- Oversee the design, execution, and reporting of clinical studies, including investigator-initiated research.
- Ensure clinical programs meet regulatory requirements and support product approvals and reimbursement strategies.
- Monitor clinical study performance, timelines, budgets, and quality metrics.
- Oversee clinical data analysis and interpretation to support publications, regulatory submissions, and commercial initiatives.
- Lead interactions with regulatory bodies (FDA, EMA, etc.) related to clinical development plans, study designs, and submissions.
- Make educational presentations to senior doctors and researchers.
Medical Affairs
- Develop and implement medical strategies supporting commercial products and future product launches.
- Build and maintain relationships with leading spine surgeons and other healthcare professionals.
- Oversee scientific communications, medical education programs, advisory boards, investigator meetings, and publication strategy.
- Ensure medical information is scientifically accurate, balanced, and compliant with applicable regulations.
- Guide post-market clinical evidence generation and real-world evidence initiatives.
- Lead post-market clinical follow-up (PMCF) programs and real-world evidence generation.
- Provide medical and scientific information to respond to KOLs technical questions about our products.
Commercial Partnership
- Partner with Commercial leadership to develop evidence-based market adoption strategies.
- Provide medical expertise supporting product launches, physician education, and reimbursement initiatives.
- Participate in customer visits, national meetings, and industry conferences.
Compliance and Governance
- Ensure compliance with FDA, international regulatory requirements, Good Clinical Practice (GCP), and applicable industry standards.
- Partner with Regulatory Affairs to support global regulatory submissions and interactions with health authorities.
- Maintain oversight of medical governance, clinical ethics, and scientific integrity.
Team & Operational Leadership
- Recruit, develop, and retain high-performing Medical Affairs and Clinical Affairs teams.
- Manage budgets, timelines, and resources to ensure efficient execution of clinical and medical programs.
- Establish organizational objectives, performance metrics, and succession planning.
Qualifications:
- Education:
- BSc in biological, biomedical or related sciences required.
- Advanced degree required (MD, DO, or PhD in a relevant scientific discipline).
- Experience:
- 15+ years of executive leadership experience within Medical Affairs and Clinical Affairs.
- Proven track record of leading successful interactions with regulatory agencies.
- Experience supporting commercialization of innovative medical technologies.
- Skills:
- Exceptional communication, leadership, and stakeholder management skills.
- Ability to thrive in an entrepreneurial, fast-paced biotech environment.
- Knowledge of relevant quality control and regulatory systems and compliance requirements.
- Strong physician credibility and external relationship management skills.
- Deep knowledge of spine surgery, orthopedic medicine, biologics, or regenerative technologies.
