Senior Director, Clinical Affairs #0912

AI overview

Lead the clinical evidence strategy and execution, ensuring compliance and quality in clinical programs for a global medical technology organization.

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.

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 to current employees in similar roles. Salary ranges may vary based on role and location.

 

Compliance with Laws: Both Keller Executive Search and our clients comply with federal, state, and local laws governing nondiscrimination in employment. This policy applies to all employment terms and conditions, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

 

Workplace Harassment: Both Keller Executive Search and our clients expressly prohibit any form of workplace harassment based on race, skin color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status.

 

E-Verify Participation: Keller Executive Search and/or our clients may participate in E-Verify. Information about E-Verify participation will be provided during the application process where applicable.

 

Privacy and Pay Equity:

 

California Residents: For more information about the categories of personal information we collect for recruiting and employment purposes, please review our Privacy Policy at www.kellerexecutivesearch.com.

Colorado, Nevada, New York City, California, and Washington Residents: Compensation information is available in the job post or will be provided during the interview process if not initially available.

Both Keller Executive Search and our clients are committed to pay equity and conduct periodic pay equity analyses in accordance with applicable laws.

 

State-Specific Information:

 

Rhode Island: We do not request or require salary history from applicants.

Connecticut: We provide wage range information upon request or before discussing compensation.

New Jersey: We do not inquire about salary history unless voluntarily disclosed.

 

Veteran Status: Both Keller Executive Search and our clients provide equal employment opportunities to veterans and comply with applicable state laws regarding veteran preference in employment. If you are a veteran, please inform us during the application process.

 

Genetic Information: In accordance with federal and state laws, both Keller Executive Search and our clients do not discriminate based on genetic information. We do not request or require genetic information from applicants or employees, except as permitted by law.

 

Local Laws: Both Keller Executive Search and our clients comply with all applicable local laws and ordinances regarding employment practices in the areas where we operate.

  

 

Note: This job posting may be for a position with Keller Executive Search or one of our clients. The specific employer will be identified during the application and interview process. Employment laws and requirements may vary depending on the employer and location.

Keller Executive Search International is a global executive search that recruits senior leaders for prominent brands and organizations. We offer full-spectrum services, such as Executive Search, Board Services, CEO Succession Planning, Executive Assessment, Business Culture Review, and Corporate Handover.

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Salary
$205,677 – $239,850 per year
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