The Senior Director, Clinical Evidence Strategy at Keller Executive Search will lead the development and execution of global clinical evidence strategies across the product lifecycle for a global medical technology company. This role is responsible for setting strategic direction, driving cross-functional alignment, and ensuring high-quality clinical outcomes that support regulatory pathways and business objectives.
What You'll Do
- Define clinical evidence strategies aligned to intended use, labeling objectives, and lifecycle priorities.
- Build integrated evidence plans leveraging the right mix of clinical studies and other appropriate evidence approaches.
- Establish decision points, success criteria, and evidence summaries to support product and lifecycle decisions.
- Lead clinical programs with internal stakeholders and external vendors/consultants, ensuring strong governance and delivery.
- Guide development of core clinical deliverables (from planning through reporting) and drive issue resolution as needed.
- Ensure compliance, documentation quality, and readiness practices aligned with applicable regulations and standards.
- Partner with cross-functional teams to ensure clinical evidence aligns with product documentation and risk management activities.
- Support regulatory submission planning and responses to questions as needed, providing clear, decision-ready clinical inputs.
- Collaborate with post-market partners to inform ongoing evidence planning and continuous improvement.
- Lead, mentor, and develop a high-performing team; manage performance, development, and partner oversight.
- Improve clinical workflows, templates, and enabling tools to increase quality, consistency, and scalability.
- Support planning, resourcing, and budget management for clinical evidence activities.
What We're Looking For
- Senior clinical leadership experience in medical technology or related industry.
- Proven ability to set clinical evidence strategy across the product lifecycle.
- Experience leading clinical programs with internal and external stakeholders.
- Strong understanding of regulatory requirements and standards for clinical evidence.
- Demonstrated success in delivering high-quality clinical submissions and supporting regulated product pathways.
- Experience in cross-functional collaboration, particularly with regulatory, product development, and post-market teams.
- Track record of building and leading high-performing clinical teams.
- Operational excellence in clinical processes, governance, and tools.
Work Mode
Global role with no specified locations or flexibility details.
Keller Executive Search is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.
