Sr./ Director of Clinical Strategy 

 

Senior/ Director of Clinical Strategy
Location: Remote
Travel: Up to 30% (varies based on active studies and trial activity)

Position Summary

The Senior Director of Clinical Strategy plays a critical leadership role in developing and executing clinical strategies that support regulatory, commercial, and research objectives. This individual will be responsible for ensuring the integrity of clinical study design, execution, and data management in alignment with legal, regulatory, and contractual requirements. The role includes developing clinical protocols, collaborating with cross-functional teams and investigators, monitoring study progress, and driving the creation of clinical evidence to support business growth.

This is a strategic, hands-on position ideal for a seasoned clinical professional with a proven track record in managing clinical programs, regulatory submissions, and evidence generation within the MedTech industry.

Key Responsibilities

  • Clinical Strategy & Protocol 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).
  • Clinical Execution & Oversight
    • 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.
  • Data Integrity & Reporting
    • 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.
  • Scientific Communication & Publication
    • Develop and contribute to scientific manuscripts, conference presentations, and publications.
    • Provide clinical evidence to support marketing claims and product positioning.
  • Cross-Functional Collaboration
    • 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.
  • Leadership & Innovation
    • Guide cross-functional teams in the generation of robust clinical evidence.
    • Maintain awareness of evolving industry trends, research methodologies, and regulatory changes.

Required Qualifications

  • Minimum 5 years of experience in clinical strategy, clinical operations, or related leadership roles in medtech or life sciences.
  • Deep knowledge of clinical trial design, including randomized controlled trials and regulatory standards (FDA, IRB).
  • Strong leadership, communication, and interpersonal skills with the ability to influence diverse stakeholders.
  • Proficiency in interpreting clinical data, regulatory submissions, and medical writing.
  • Hands-on experience with clinical trial management systems, data analytics, and statistical tools.

Education

  • Bachelor’s degree in life sciences, medical sciences, or a related field is required.
  • Advanced degree (Master’s, PhD, or equivalent) strongly preferred.