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Director, US Medical Promotional Review Cardiovascular

$228.6k - $266.7k

Cytokinetics

Cytokinetics seeks a Director of US Promotional Medical Review for Cardiovascular to oversee scientific integrity and medical accuracy of promotional and non-promotional materials. The role requires expertise in cardiovascular disease, regulatory compliance, and cross-functional collaboration to ensure communications meet FDA standards and internal policies.

Responsibilities

  • Maintain expert therapeutic area and product knowledge through ongoing literature and guideline assessment
  • Provide medical guidance in MLR meetings and cross-functional strategic initiatives
  • Critically evaluate promotional and non-promotional tactics for compliance, accuracy, and evidence support
  • Review evidence supporting promotional claims for scientific rigor, balance, and statistical reliability
  • Develop and deliver training for cross-functional teams on MLR procedures and policy requirements

Requirements

  • Advanced degree (PharmD, PhD, or MD preferred)
  • 5-7 years pharmaceutical/healthcare industry experience with promotional MLR review
  • Cardiovascular therapeutic area experience preferred
  • Strong clinical trial design and biostatistics knowledge with data interpretation skills
  • Familiarity with FDA advertising regulations, OPDP guidance, and warning letters
  • Experience interpreting trial data and Real-World Evidence with FDAMA 114 knowledge
  • Cross-functional leadership and stakeholder influence ability

Compensation: $228,600-$266,700 base

Vacancy posted 7 days ago
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