Senior Director, Clinical Affairs

Role Overview

• 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.