Senior Medical Director / Medical Director, Pharmacovigilance

Company Overview:

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 that includes a suite of gene editing and delivery technologies and is in the process of building internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of potential therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. 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.

Position Overview:

The Medical Director of Pharmacovigilance (PV) will provide clinical/scientific/PV expertise to lead a full range of core medical safety activities including the development and oversight of benefit-risk strategies, risk management, and safety surveillance activities in support of Beam’s products throughout their lifecycle. This includes the development of processes to support proactive identification, evaluation, and risk management of safety risks for assigned Beam products. This individual will also contribute to a variety of PV activities including but not limited to Pharmacovigilance department organization and infrastructure development. In addition, she/he will also function in a company matrix environment collaborating with all levels of the organization as well as with external Regulatory Authorities.

Primary Responsibilities:

• Provide dynamic leadership, strategic direction and governance of patient safety and PV risk management activities across Beam’s portfolio.
• Lead signal detection and risk management activities for assigned products including individual and aggregate data analyses, preparing signal assessment, tracking and validation documents; lead cross functional teams to analyze and interpret safety data; preparing action and communication plans (written and verbal) to mitigate/manage product risks, in collaboration with key stakeholders.
• Lead proactive and ongoing analysis and interpretation of non-clinical data, clinical, post-marketing, scientific literature and other sources to establish the risk profile for products early in development, with ongoing assessment of benefit-risk and update of benefit-risk documents throughout the lifecycle of assigned products.
• Lead PV during interactions with Regulatory Authorities (RA), including authoring and review of regulatory meeting materials, addressing questions from RAs, and attending meetings as the PV subject matter expert (SME) during RA interactions.
• Perform individual case safety report (ICSR) medical review to ensure accurate medical coding, seriousness, expectedness and company causality assessment, ensure appropriate medical interpretation, completeness, and accuracy of information, review and draft queries, and prepare or review the analysis of similar events (AOSE) as required.
• Lead multidisciplinary Safety Management Committee (SMC) and Executive Safety Committee (ESC) whose responsibilities include safety surveillance (signal detection and evaluation), risk management planning, and making recommendations regarding risk assessment, communication plan and labeling, as appropriate.
• Serve as PV SME in support of regulatory filing activities (e.g. BLA) for assigned product(s) to develop the safety strategy, author/review safety-related content, participate in filing preparation meetings and deliverables, and support labeling activities.
• Collaborate with cross functional team, including Clinical Development, Regulatory Affairs, Biostatistics, and other functional areas to design, evaluate, implement, and oversee safety risk mitigation strategies (REMS, Risk Management Plan, Post-Approval Safety Surveillance) to ensure safe and appropriate use of company products in compliance with global regulatory requirements.
• Address internal/external safety-related requests, including questions from Health Authorities, Ethics Committees, Data Monitoring Committees, Safety Review Committees (both written and verbal).
• Provide guidance regarding Statistical Analysis Plans and format of safety data for analyses e.g. tables, listings.
• Author and/or review pre- and post-marketing aggregate safety reports including DSUR, 6-monthly line listing reports, PSUR, PBRER, PADER, IND Annual Reports.
• Provide PV expertise to support full lifecycle drug development and study execution; represent PV at study execution and stra