Director, US Medical Promotional Review Cardiovascular
$228.6k - $266.7kCytokinetics
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
$186k - $235k
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