Director, US Medical Promotional Review Cardiovascular
Cytokinetics
August 19, 2026
On-site
San Francisco Bay Area
Medical Affairs
Key Responsibilities:
- Maintain expert-level therapeutic area and product knowledge via review of CV published literature, treatment guidelines, internal resources, and data.
- Provide medical guidance in Medical, Legal, Regulatory (MLR) meetings and initiatives, including medical/promotional review, disease/brand and launch planning, and cross-functional strategic initiatives.
- Critically evaluate complex promotional and non-promotional tactics to ensure fair balance, medical/scientific accuracy, robust evidence support, appropriate statistical interpretation, and compliance with applicable regulations and guidance.
- Review and evaluate evidence supporting promotional claims for comprehensiveness, balance, unbiased presentation, scientific rigor, and statistical reliability.
- Align and build relationships across Marketing, Market Access, Medical Affairs, Corporate Communications, Training, Legal/Regulatory Affairs, and Compliance.
- Participate in internal/external meetings (training, education, medical congresses, matrix team meetings) to stay current.
- Develop and deliver training on MLR SOPs, policies, and data-source standards.
- Contribute to development and improvement of processes/standards for scientific materials and compliant data-source requirements.
- Apply digital and AI-enabled solutions to improve efficiency, consistency, and scalability.
- Collaborate with medical communications vendors/agency partners as needed.
- Participate in periodic review of approved materials; support content governance, process optimization, and document lifecycle management.
Qualifications:
- Advanced scientific degree (PharmD, PhD, or MD preferred).
- 5–7+ years in pharma/healthcare with direct promotional MLR review experience; cardiovascular experience preferred.
- Strong clinical trial design and applied biostatistics knowledge.
- Familiarity with FDA advertising/promotion regulations, OPDP enforcement trends, warning letters, and related guidance.
- Ability to interpret trial data and Real-World Evidence; FDAMA 114 experience; data consistent with FDA-approved labeling (CFL).
- Strong written/verbal communication; cross-functional partnership and influence.
- Solution-oriented; able to lead change in complex environments.
- Ability to travel ~10%.
Application Instructions:
- Please review the General Data Protection Regulation (GDPR) policy prior to applying.
- Maintain expert-level therapeutic area and product knowledge via review of CV published literature, treatment guidelines, internal resources, and data.
- Provide medical guidance in Medical, Legal, Regulatory (MLR) meetings and initiatives, including medical/promotional review, disease/brand and launch planning, and cross-functional strategic initiatives.
- Critically evaluate complex promotional and non-promotional tactics to ensure fair balance, medical/scientific accuracy, robust evidence support, appropriate statistical interpretation, and compliance with applicable regulations and guidance.
- Review and evaluate evidence supporting promotional claims for comprehensiveness, balance, unbiased presentation, scientific rigor, and statistical reliability.
- Align and build relationships across Marketing, Market Access, Medical Affairs, Corporate Communications, Training, Legal/Regulatory Affairs, and Compliance.
- Participate in internal/external meetings (training, education, medical congresses, matrix team meetings) to stay current.
- Develop and deliver training on MLR SOPs, policies, and data-source standards.
- Contribute to development and improvement of processes/standards for scientific materials and compliant data-source requirements.
- Apply digital and AI-enabled solutions to improve efficiency, consistency, and scalability.
- Collaborate with medical communications vendors/agency partners as needed.
- Participate in periodic review of approved materials; support content governance, process optimization, and document lifecycle management.
Qualifications:
- Advanced scientific degree (PharmD, PhD, or MD preferred).
- 5–7+ years in pharma/healthcare with direct promotional MLR review experience; cardiovascular experience preferred.
- Strong clinical trial design and applied biostatistics knowledge.
- Familiarity with FDA advertising/promotion regulations, OPDP enforcement trends, warning letters, and related guidance.
- Ability to interpret trial data and Real-World Evidence; FDAMA 114 experience; data consistent with FDA-approved labeling (CFL).
- Strong written/verbal communication; cross-functional partnership and influence.
- Solution-oriented; able to lead change in complex environments.
- Ability to travel ~10%.
Application Instructions:
- Please review the General Data Protection Regulation (GDPR) policy prior to applying.