Director, Medical Information

Beam Therapeutics•Cambridge, MA

2d•Onsite

About The Position

Beam is seeking a driven and scientifically rigorous Director of Medical Information to build and lead the Medical Information (MI) function. This is a hands-on leadership role well-suited to a motivated individual contributor and emerging leader who is passionate about establishing strong operational foundations and delivering high-quality scientific content in the rare disease space. The Director of Medical Information will design and implement core MI capabilities — including inquiry management systems, standard response documents, and medical review workflows — positioning the organization for its first commercial launch and scaling for future clinical programs. The Director of Medical Information will also play an active role in the company's Medical Affairs AI initiatives, contributing scientific and operational expertise to the responsible deployment of AI-enabled tools for content generation and knowledge management.

Requirements

Advanced scientific degree required: PharmD, MD, PhD, or equivalent in life sciences, pharmacy, or a related field.
Minimum 7 years of experience in Medical Information, Medical Affairs, or Medical Communications within the pharmaceutical or biotechnology industry.
Experience contributing to or building Medical Information capabilities, including SOP development and content library management.
Solid working knowledge of medical review processes (MRC/PRC) and promotional/non-promotional content review, with familiarity with applicable FDA and EMA regulations.
Strong scientific writing skills with experience developing SRDs, medical information responses, and clinical content for internal and external audiences.
Ability to work effectively cross-functionally in a fast-paced, pre-commercial biotech environment with lean teams and evolving priorities.
Interest in or exposure to rare disease therapeutic areas, including the scientific and operational challenges of small patient populations.

Nice To Haves

Experience in cell and gene therapy, gene editing, or other advanced therapy medicinal products, preferred.
Exposure to AI/ML applications in Medical Affairs or Medical Information, including prompt engineering, LLM evaluation, or AI governance, preferred.
Familiarity with medical information platforms (e.g., Veeva Vault, Salesforce Health Cloud, MedAnswers) or emerging AI-powered MI solutions, preferred.
Experience supporting pre-BLA/pre-NDA activities or commercial launch readiness for orphan-designated or first-in-class therapies, preferred.

Responsibilities

Establish the Medical Information department from the ground up, including defining the operating model, staffing plan, technology infrastructure, and standard operating procedures (SOPs).
Develop and maintain the MI quality framework to ensure all scientific content meets regulatory, compliance, and scientific integrity standards.
Serve as the internal subject matter expert on medical information best practices, regulatory expectations (FDA, EMA), and industry benchmarks for rare disease and advanced therapies.
Build and oversee the medical review process for promotional and non-promotional materials, ensuring scientific accuracy and alignment with label and clinical data.
Partner in the establishment of a Medical Review Committee (MRC) / Promotional Review Committee (PRC), collaborating closely with Regulatory Affairs, Legal, and Commercial teams.
Create and maintain a comprehensive library of standard response documents (SRDs), custom responses, and medical FAQs covering the company's cell and gene therapy pipeline across rare disease indications.
Author and review medical information letters, disease education materials, clinical summaries, and scientific dossiers for internal and external use.
Ensure all MI content reflects the most current evidence base, including clinical trial data, real-world evidence, and peer-reviewed literature.
Partner with Medical Science Liaisons (MSLs), Clinical Development, and Commercial teams to develop scientifically rigorous training materials, slide decks, and internal reference tools.
Lead the development of pipeline and disease area resources that enable cross-functional teams to communicate accurately about the science of cell and gene therapies.
Contribute to publication planning and medical education initiatives, supporting the Medical Affairs strategy for pre-launch and post-launch activities.
Collaborate with Patient Advocacy and Medical Communications to ensure content is accessible, accurate, and patient-centered.
Contribute as a Medical Affairs subject matter expert to the company's AI strategy, partnering with Data Science, IT, and Medical Affairs leadership to evaluate and implement AI-enabled solutions.
Support the design and validation of AI-assisted medical information tools, including intelligent response generation, literature surveillance automation, and content quality-checking workflows.
Participate in establishing governance frameworks for responsible AI use in medical communications, including bias assessment, hallucination mitigation, and compliance review protocols.
Monitor the evolving regulatory and industry landscape around AI in medical affairs (e.g., FDA guidance, ISPE, PhRMA frameworks) and translate insights into actionable policies.