Senior Manager of Clinical Strategy

Clinical Strategy And Development

Lead the development of IRB and clinical study protocols in alignment with company objectives. Collaborate with surgeons and clinical advisors to design impactful studies that address business and clinical needs. Participate in the overall clinical strategy planning process, including statistical analysis plans and protocol review cycles. Submit and manage regulatory applications (FDA and other global agencies).

Oversee clinical study activities including site selection, investigator engagement, initiation, monitoring, and study closeout. Ensure studies are conducted in compliance with approved protocols, regulatory standards, and timelines. Perform site visits, oversee test article reconciliation and disposition, and maintain accurate documentation.

Ensure the accurate transmission and validation of clinical data to data management centers. Resolve case report discrepancies and ensure completeness and integrity of clinical records. Author or support the development of clinical study reports, white papers, and regulatory submissions.

Develop and contribute to scientific manuscripts, conference presentations, and publications. Provide clinical evidence to support marketing claims and product positioning.

Work closely with product management, engineering, regulatory, and medical affairs to ensure alignment between product development and clinical evidence. Identify clinical evidence gaps across the product portfolio and recommend solutions.

Guide cross-functional teams in the generation of robust clinical evidence. Maintain awareness of evolving industry trends, research methodologies, and regulatory changes.