Senior Director, Clinical Affairs #0912

Overview

Our client, a global medical technology organization, is looking for a senior clinical leader to own clinical evidence strategy and oversee clinical affairs execution across both new product development and lifecycle programs. This role is well-suited to someone who can set evidence direction, align diverse stakeholders, and drive strong clinical outcomes that enable regulated product pathways and business objectives.

What You’ll Own

• 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..

Key Responsibilities

Evidence Strategy & Portfolio Leadership

• 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.

Clinical Program Oversight

• 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.

Cross-Functional Collaboration & Submission Support

• 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.

Leadership & Operational Excellence

• 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

Qualifications

Required

• 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.

Preferred

• Experience improving clinical operations and enabling systems within global organizations.
• Advanced degree and/or relevant professional certification(s).

Benefits

Compensation & 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.

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