Responsibilities
- Provide strategic, scientific, and operational leadership for all US Medical Affairs activities and functions across therapeutic franchises.
- Lead and manage Medical Affairs Directors and cross-functional teams to ensure strategic alignment with brand objectives and evidence generation needs.
- Oversee execution of field medical strategies, including MSL team direction, scientific exchange, and external stakeholder engagement.
- Guide development and implementation of post-marketing clinical research, including IITs, RWE initiatives, and Phase IV studies.
- Drive strategic publication planning and execution, including congress presentations, abstracts, and peer-reviewed manuscripts.
- Ensure high-impact collaboration with Commercial, Market Access, Regulatory, HEOR, and Clinical Development to deliver integrated medical strategy and cross-functional execution.
- Maintain robust relationships with national and regional KOLs, scientific experts, cooperative groups, and advocacy organizations to inform and support medical strategy.
- Lead planning and execution of medical education and advisory boards to generate scientific insights and inform product positioning.
- Supervise and ensure compliance in all medical affairs-related activities, including medical review of promotional materials (MLR), SOP development, and legal/regulatory standards.
- Oversee Medical Affairs contributions to value dossiers (e.g., AMCP), QoL research, and health economics collaborations.
- Manage strategic decisions for independent medical education (IME) grants and medical education initiatives.
- Support the design and delivery of core deliverables such as CMEs, symposia, scientific roundtables, and congress support.
- Collaborate on initiatives to ensure alignment and knowledge sharing across regions and therapeutic areas.
- Manage department budgets, ensuring effective resource allocation and cost-efficient operations.
- Represent Catalyst in external forums including scientific, payor, government, and advocacy meetings to articulate medical strategy and scientific leadership.
- Serve as a key internal expert for due diligence assessments and external partnership evaluations when relevant.
Requirements
- MD preferred; PharmD, or PhD in relevant clinical scientific field will be considered.
- Minimum 20 years of progressive experience in Medical Affairs leadership roles in the biopharmaceutical industry, with 10+ years leadership of full Medical Affairs organization preferred.
- Demonstrated success in building and leading high-performing, cross-functional medical affairs teams.
- Strong experience in publication strategy, scientific exchange, and post-marketing clinical programs.
- Proven ability to develop and execute strategic medical plans aligned with corporate goals in a matrixed, fast-paced environment.
- Expertise in regulatory standards, medical compliance, and MLR processes in the US market.
- Exceptional leadership, interpersonal, and communication skills with the ability to influence at executive and board levels.
- Managerial and budget management skills and experience in a complex organization of diverse functions in Medical Affairs.
- Strong organizational and analytical skills with the ability to manage multiple complex priorities simultaneously.
- Willingness and ability to travel up to 60%, with required travel for national and regional KOL engagement, conferences, and internal leadership meetings.
Preferred Qualifications (Nice to Have)
- Experience with rare diseases, neuroscience, and a broad array of therapeutic areas highly preferred.
Location
- This is a remote position with up to 60% travel.
- Includes the expectation to work on-site at the Coral Gables headquarters at least one week per month.
Salary
- The base salary for this position will range from $390,000 to $440,000. Candidate experience, professional licensing, and geographic location will be taken into consideration.
Benefits
- Competitive wages and comprehensive benefits including health, dental, and vision insurance.
- Generous paid time off.
- A retirement savings plan with Company Match, and more.
About the Company
The Sr. Vice President of Medical Affairs will serve as the enterprise-wide leader responsible for developing and executing integrated medical affairs strategies across Catalyst’s US franchises. Reporting to the Chief Medical Officer, this executive will drive all aspects of medical affairs planning, execution, and performance—including field medical operations and the MSL teams, scientific communications, medical information, publication planning, IISs and Medical Grants, and external engagement with thought leaders. The SVP will oversee the Medical Affairs department and teams across franchises, ensuring alignment with commercial, market access, regulatory, and clinical development teams. This individual will be accountable for establishing best-in-class medical affairs practices, fostering scientific and stakeholder relationships, and driving evidence generation and scientific exchange to support Catalyst’s portfolio. The role also includes oversight of medical/scientific contribution and cross-functional collaborations to support product launches, lifecycle management, and market differentiation. The SVP of Medical Affairs will be responsible for carrying out and overseeing the Medical Affairs work with adherence to both internal and external industry and regulatory requirements and standards of compliance. Catalyst Pharmaceuticals is an Equal Opportunity Employer committed to a culturally diverse workforce.
Category
Healthcare