VP, Medical Affairs - US Biomedicine *PC 1473

Your Tasks: 

This role will be responsible for developing and executing the medical plans for the company's first CAR T-cell therapy, ensuring the generation and communication of high-quality scientific and clinical evidence to support its successful launch. This individual will play a critical role in preparing for commercialization, building key external relationships, and ensuring alignment with regulatory and payer expectations. This leader will oversee medical plans, evidence generation, medical information, medical communications, and the field medical team. They will build and lead a high-performing Medical Affairs team, fostering scientific excellence, collaboration, and patient-centric innovation while ensuring compliance with all regulatory requirements. This position will work cross-functionally with R&D, Commercial, Market Access, and Regulatory teams to shape the company’s CAR T launch strategy and ensure its success in the market.

This position will report to the Chief Officer, North America Biomedicine.

Essential Duties and Responsibilities:

• Develop and execute the medical plans to support the launch and lifecycle management of the company’s first CAR T-cell therapy.
• Build, lead, and develop a high-performing Medical Affairs team, including Medical Science Liaisons (MSLs), medical communications, and scientific affairs professionals.
• Oversee the development and management of the Medical Information function, engaging closely with pharmacovigilance, and ensuring timely, accurate, and compliant responses to inquiries from healthcare providers, patients, and internal stakeholders.
• Lead scientific engagement efforts, establishing and maintaining strong relationships with KOLs, academic institutions, and professional organizations to educate and advocate for CAR T therapy.
• Oversee the development and execution of medical education, medical communications, and scientific publication plans to ensure the dissemination of high-quality, evidence-based information.
• Guide real-world evidence and health economics outcomes research (HEOR) strategies in partnership with Market Access to support payer engagement and value demonstration.
• Ensure clinical research incorporates HEOR needs and supports evidence generation strategies that address both regulatory and payer requirements.
• Oversee the strategy and management of the MSL team, ensuring effective field engagement and scientific exchange with healthcare providers in preparation for launch.
• Work closely with Clinical Development to provide medical insights that inform clinical trial design, patient selection strategies, and biomarker development.
• Partner with Commercial, Market Access, and Regulatory teams to ensure that medical affairs strategies align with broader corporate objectives and compliance standards.
• Ensure strict adherence to industry regulations (e.g., FDA, OIG, PhRMA, and global regulatory authorities) in all medical affairs activities.
• Collaborate with Finance and Compliance teams to ensure accurate and compliant reporting of medical activities and adherence to transparency requirements.
• Stay abreast of evolving scientific, regulatory, and market trends to anticipate challenges and opportunities in the CAR T-cell therapy landscape.

Requirements: 

• MD, PharmD, or PhD in relevant life sciences discipline required; Minimum of fifteen (15) years of progressive leadership experience in Medical Affairs within the pharmaceutical industry, preferably in oncology, cell therapy, gene therapy, or rare diseases; or a combination of education and experience. 
• Proven experience in launching high-science, high-touch therapies, with a strong understanding of CAR T-cell therapy or other advanced therapies.
• Experience engaging with global regulatory and health authorities to support product approvals and post-marketing commitments.
• Strong leadership in KOL engagement, scientific exchange, and medical education strategies.
• Demonstrated ability to build and lead high-performing medical teams, including MSLs, medical information, and scientific affairs professionals.

• Ability to travel domestically and internationally as required (30-50%)

Knowledge, Skills & Abilities

• Deep understanding of medical and regulatory affairs compliance (e.g., FDA, OIG, PhRMA guidelines).
• Expertise in clinical research, medical communications, and real-world evidence generation.