Senior Director, Clinical Affairs
Keller Executive Search International
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $205,677 - $239,850 per year
Job Level
About the role
- Senior-level oversight of clinical programs and external partners to ensure quality, compliance, and on-time delivery.
- Clear evidence narratives and clinical content that enable submissions, lifecycle updates, and internal decision-making.
- Operational excellence across clinical processes, governance, and tools—evolving ways of working as the portfolio expands.
- A global clinical evidence strategy that links product goals to fit-for-purpose evidence plans throughout the product lifecycle.
- Establish decision points, success measures, and evidence summaries to support product and lifecycle decisions.
- Build integrated evidence plans using the right combination of clinical studies and other appropriate evidence approaches.
- Set clinical evidence strategies aligned to intended use, labeling goals, and lifecycle priorities.
- Ensure compliance, high-quality documentation, and readiness practices aligned with relevant regulations and standards.
- Guide delivery of core clinical deliverables (from planning through reporting) and drive issue resolution as needed.
- Lead clinical programs with internal stakeholders and external vendors/consultants, ensuring strong governance and execution.
- Collaborate with post-market partners to inform ongoing evidence planning and continuous improvement.
- Support regulatory submission planning and responses to questions as needed, providing clear, decision-ready clinical input.
- Partner cross-functionally to ensure clinical evidence aligns with product documentation and risk management activities.
- Support planning, resourcing, and budget management for clinical evidence activities.
- Improve clinical workflows, templates, and enabling tools to strengthen quality, consistency, and scalability.
- Lead, mentor, and develop a high-performing team; manage performance, development, and partner oversight.
Requirements
- 12+ years in medical devices (or a closely related regulated industry), including leadership experience in Clinical Affairs, Clinical Evidence, or Clinical Strategy.
- Strong working knowledge of regulated development practices and clinical research/quality/risk standards.
- Experience supporting audits/inspections and establishing sustainable compliance practices.
- Bachelor’s degree in a scientific, engineering, or related field.
- Excellent communication skills with demonstrated executive-level stakeholder management.
- Demonstrated ability to lead cross-functional programs in matrixed environments, including multi-region execution.
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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical programs oversightclinical evidence strategyregulatory submission planningclinical research standardsquality documentationevidence planningclinical workflows improvementbudget managementrisk managementaudit/inspection support
Soft Skills
communication skillsstakeholder managementleadershipcross-functional collaborationmentoringperformance managementissue resolutionoperational excellenceteam developmentstrategic thinking