Own clinical evidence strategy and clinical affairs execution across new product development and lifecycle initiatives.
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.
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.
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.

Bachelor’s degree in a scientific, engineering, or related discipline.
12+ years in medical devices (or closely related regulated industry), including leadership in Clinical Affairs, Clinical Evidence, or Clinical Strategy.
Proven ability to lead cross-functional programs in matrixed environments, including multi-region execution.
Strong working knowledge of regulated development practices and clinical research/quality/risk standards.
Experience supporting audits/inspections and building sustainable compliance practices.
Excellent communication skills and executive-level stakeholder management.
Advanced degree and/or relevant professional certification(s).
Experience improving clinical operations and enabling systems in global organizations.

$205 677.32
$239 850.22 base salary (depending on experience)
Annual performance bonus and long-term incentive opportunity.
Comprehensive benefits package, including health coverage and retirement savings.

Senior Director, Clinical Evidence Strategy

Key skills