Beam Therapeutics
Director, Medical Information
Cambridge, MA · Director · Full-time
Sponsorship not specified$210k-$260kDetected 35 days ago
Machine LearningData ScienceLLMsSalesforceFDA RegulatoryCRISPRScientific WritingLeadershipCommunicationWritingRegulatory Affairs
About the role
- Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines.
- To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities.
- This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs.
Responsibilities
- Develop and maintain the MI quality framework to ensure all scientific content meets regulatory, compliance, and scientific integrity standards.
- 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.
Requirements
- Advanced scientific degree required: PharmD, MD, PhD, or equivalent in life sciences, pharmacy, or a related field.
- Ability to work effectively cross-functionally in a fast-paced, pre-commercial biotech environment with lean teams and evolving priorities.
- 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.
- Interest in or exposure to rare disease therapeutic areas, including the scientific and operational challenges of small patient populations.
- 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.
- Onsite requirements: Must be able to work onsite as required and willing to have a flexible schedule during peak times, which may include supporting critical operations outside of normal work hours, as needed.
- The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, education, scope of job, internal comparisons, and market data.
- Beam Pay Range
Nice to have
- Experience in cell and gene therapy, gene editing, or other advanced therapy medicinal products, preferred.
- Experience supporting pre-BLA/pre-NDA activities or commercial launch readiness for orphan-designated or first-in-class therapies, preferred.
Compensation
- The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting.
Benefits
- Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.
- Establish the Medical Information department from the ground up, including defining the operating model, staffing plan, technology infrastructure, and standard operating procedures (SOPs).
- 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.
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