Keller Executive Search · 5 hours ago
Senior Director, Clinical Evidence Strategy
United States
Full-time
Remote
Director/Executive
$206K/yr - $240K/yr
12+ years expKeller Executive Search is representing a global medical technology company seeking a senior clinical leader to own clinical evidence strategy and clinical affairs execution across new product development and lifecycle initiatives. The role involves setting evidence direction, driving cross-functional alignment, and delivering high-quality clinical outcomes that support regulated product pathways and business goals.
Staffing & Recruiting
Responsibilities
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
Qualification
Required
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
Preferred
Advanced degree and/or relevant professional certification(s)
Experience improving clinical operations and enabling systems in global organizations
Benefits
Annual performance bonus and long-term incentive opportunity.
Comprehensive benefits package, including health coverage and retirement savings.
Company
Keller Executive Search
Keller Executive Search is a boutique executive recruitment and advisory firm dedicated to connecting top-tier talent with leading organizations worldwide.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase