Director, US Medical Promotional Review Cardiovascular
About The Position
Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. The Director, US Promotional Medical Review, Cardiovascular (CV) plays a critical role in ensuring scientific integrity, medical accuracy, and appropriate communication of data across promotional and non-promotional materials in the US. Serving as a medical and scientific expert for assigned therapeutic areas and products, this individual will provide timely, rigorous review of materials in accordance with internal policies, established review standards, and applicable US laws, regulations, and regulatory guidance. Beyond formal review responsibilities, this role will serve as a solutions-oriented partner to Medical Affairs, Commercial, Regulatory, Legal, and Compliance colleagues, providing thoughtful medical guidance that enables clear, accurate, and scientifically balanced communications. The role offers an opportunity to contribute to the evolution of review practices and governance, support cross-functional initiatives, and provide medical expertise to enable high-quality scientific and promotional communications.
Requirements
- Advanced scientific degree (PharmD, PhD, or MD preferred)
- Minimum of 5-7 years of pharmaceutical/healthcare industry experience including direct experience in promotional MLR review; cardiovascular experience preferred
- Strong knowledge of clinical trial design and applied biostatistics, with the ability to critically interpret clinical data and assess the scientific validity of claims and data presentations
- Knowledge of the pharmaceutical industry and external compliance, transparency, and conflict-of interest environments, including familiarity with FDA advertising and promotion regulations, OPDP enforcement trends, warning letters, and relevant FDA guidance documents
- Ability to interpret trial data and Real-World Evidence; significant experience with FDAMA 114 content and data consistent with FDA-approved labeling (CFL)
- Strong scientific/medical written and verbal communication skills
- Demonstrated ability to build strong cross-functional partnerships and influence stakeholders to achieve aligned outcomes
- Solution-oriented, highly accountable team player with the ability to thrive in a dynamic and evolving environment
- Experience leading cross-functional teams and stakeholders through change and navigating complex organizational dynamics
- Ability to travel 10% (domestically or internationally)
Responsibilities
- Maintain expert-level therapeutic area and product knowledge through ongoing assessment of relevant CV published literature, treatment guidelines, internal resources, and data
- Provide medical guidance in Medical, Legal, Regulatory (MLR) meetings and related initiatives, including medical and promotional review, disease/brand and launch planning, and key cross functional strategic initiatives
- Critically evaluate and offer strategically sound solutions for complex promotional and non- promotional tactics to ensure fair balance, medical and scientific accuracy, robust evidence support, appropriate statistical interpretation, and compliance with applicable regulations and guidance (eg, clinical guidelines, FDA/OPDP guidance)
- Review and evaluate evidence supporting promotional claims to ensure they are comprehensive, balanced, unbiased, scientifically rigorous, and statistically reliable, while advising stakeholders on appropriate scientific and clinical interpretation
- Proactively align and build strong relationships with Marketing, Market Access, Medical Affairs, Corporate Communications, Training, Legal, Regulatory Affairs, and Compliance to ensure consistent messaging and collaboration across stakeholders
- Participate in internal and external meetings (eg, training, education, medical congresses, and matrix team meetings) to stay current on regulations, medical/scientific developments, and Commercial and Medical strategy
- Develop and deliver ongoing training for internal cross-functional teams to ensure understanding of MLR standard operating procedures, policies, and standards requirements for approved data sources within materials
- Contribute to the development and continuous improvement of processes and standards for the development, review and approval of scientific materials and compliant data source requirements for materials for use with externally facing customers
- Apply digital and AI-enabled solutions to improve efficiency, consistency, and scalability of promotional review activities
- Stay informed of industry trends and promote best practice sharing across medical and promotional review teams
- Collaborate with medical communications vendors and agency partners to support review activities as needed
- Participate in periodic review of approved medical and promotional materials to ensure continued alignment with current evidence and labeling
- Contribute to content governance, process optimization, training and document lifecycle management
Benefits
- equity in the form of stock options and/or restricted stock units
- comprehensive health, dental, vision, life and disability insurance coverage
- 401k retirement benefits with employer match
- learning and wellness stipends
- paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Director
