Senior Director, Clinical Evidence Strategy
Keller Executive Search
8d ago
0$206k - $240kManagementUnited Stateshimalayas
Clinical-AffairsClinical-ResearchClinical-StrategyMedical-Device-Clinical-ResearchRegulatory-AffairsDirector
Job Description
OverviewOur client is 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. This role is ideal for someone who can set evidence direction, drive cross-functional alignment, and deliver high-quality clinical outcomes that support regulated product pathways and business goals.What You’ll OwnA global clinical evidence strategy that connects product objectives to fit-for-purpose evidence plans across the product lifecycle.Senior oversight of clinical programs and external partners to deliver quality, compliance, and on-time execution.Clear evidence narratives and clinical content that support submissions, lifecycle updates, and internal decision-making.Operational excellence across clinical processes, governance, and tools—scaling ways of working as the portfolio grows.Key ResponsibilitiesEvidence Strategy & Portfolio LeadershipDefine 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.Clinical Program OversightLead 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.Cross-Functional Collaboration & Submission SupportPartner 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.Leadership & Operational ExcellenceLead, 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.RequirementsQualificationsRequiredBachelor’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.PreferredAdvanced degree and/or relevant professional certification(s).Experience improving clinical operations and enabling systems in global organizations.BenefitsCompensation & Benefits $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.This search is being conducted under the strictest confidentiality. The client’s identity will be revealed only after NDA execution. All applications and communications will be handled with complete discretion.
Equal Employment Opportunity and Non-Discrimination Policy Equal Employment Opportunity Statement: Both Keller Executive Search and our clients are Equal Opportunity Employers. For all positions, whether with Keller Executive Search or our clients, qualified applicants will receive consideration for employment without regard to race, skin color, religion, sex, sexual orientation, gender identity, gender expression, national origin, age, protected veteran status, disability, genetic information, or any other legally protected status. Commitment to Diversity: Keller Executive Search and its clients are committed to fostering a diverse and inclusive work environment where all individuals are valued and respected. Reasonable Accommodations: Both Keller Executive Search and our clients are committed to providing reasonable accommodations to individuals with disabilities and pregnant individuals. We engage in an interactive process to determine effective, reasonable accommodations. Compensation Information: For client positions, compensation information is available in the job post. If not provided, it will be shared during the interview process in accordance with applicable laws. When required by law, salary ranges will be included in job postings. Actual salary may depend on skills, experience, and comparison t
