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Keller Executive Search International

Transforming Organisations with Exceptional Leadership

Senior Director, Clinical Affairs

DirectorDirectorFull TimeRemoteSeniorTeam 11-50H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

26 days ago

Salary

$205.7K - $239.9K / year

Seniority

Senior

Bachelor Degree12 yrs expEnglish

Job Description

• 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.

Job 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.

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