Senior Medical Director / Medical Director

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 strategic forums.
• Support and/or serve as PV SME during inspection readiness activities, internal audits, and external inspections.
• Develops expertise in gene editing, with continuous knowledge acquisition and education regarding current safety matters relating to gene editing.
• Develop training materials and conduct training on PV related content, including presentations at Investigator Meetings or Site Initiation Visits, as needed.
• Review medical/scientific literature to support signal detection activities and aggregate reporting for products.
• Contribute to the development and review of clinical, regulatory, and scientific documents including protocols, informed consent forms, clinical study reports, external manuscripts/journal articles/publications, case report forms, statistical analysis plans, integrated summaries of safety (ISS), New Drug or Biologic License Applications (NDA/BLA), and/or other documents as needed, ensuring safety content and messaging is harmonized where applicable.
• Lead/contribute to safety data analyses, messaging and presentations for DMC meetings.
• Develop or support development of standard operating procedures (SOPs) and/or other process related documents e.g. Safety Management Plans, Work Instructions.
• Contribute to vendor governance activities and oversight of key performance indicators.
• Lead and/or contribute to the development and maintenance of Reference Safety Information (RSI) including Company Core Data Sheet (CCDS), Company Core Safety Information (CCSI), Investigator Brochure (IB), and/or other product labeling.
• Participates in MedDRA and WHODrug coding and SAE reconciliation activities.
• Participate in the development of PV organizational strategy, goals, and objectives and assist with implementation and training to support department goals and initiatives.
• Maintain knowledge of new PV/safety regulations and guidance from regulatory authorities, BEAM SOPs, and quality standards.
• Maintain knowledge of disease indications for assigned products (full lifecycle).
• Support hiring, orientation, management, mentorship, and development of PV team.
• Support organizational leadership in assigned activities and initiatives.
• Maintain knowledge of disease indications for assigned Beam products.
• Other duties, as assigned.

Qualifications:

• MD required, Board certification preferred with 15+ years of experience.
• 5+ years of pharmacovigilance experience; other relevant experience may be considered.
• Experience in cell or gene therapy preferred; experience in other serious conditions, including oncology, rare or fatal conditions will be considered.
• Experience as safety lead for asset/approved drug product e.g. Global Safety Lead with responsibility for PV documents including but not limited to DSUR/PBRER; IB and ICF safety sections; risk management strategies and plans.
• Oversight experience of global medical safety activities including asset / approved product level safety governance, operations and risk management strategies in pre and post marketing environments.
• Demonstrated knowledge of global PV regulatory environment with working knowledge of international regulations including but not limited to FDA, EMA, ICH guidelines and regulations pertaining to clinical development and post-marketing safety environments.
• Working knowledge of industry standard safety databases (ARGUS and ARISg) and other electronic data capture systems.
• Knowledge of MedDRA dictionary with relevance to adverse event coding.
• Excellent knowledge of drug development process, including clinical trial methodology, medical terminology and general principles of clinical assessment of AEs.
• Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data and developing risk management/mitigation strategies.
• Experienced in supporting health authority interactions, both written and verbal.
• Ability to navigate fast-paced and dynamic work environment; ability to manage and prioritize multiple projects and demands simultaneously with ability to adjust to changing priorities and work effectively under pressure; organizational and prioritization skills a must.
• Demonstrates leadership and interacts collaboratively and effectively in a team environment (e.g. Clinical Operations, Clinical Science, Data Management, Medical Affairs) and with external vendors and stakeholders.
• Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
• Excellent leadership and communication skills with ability to influence at all levels of the organization.
• International/domestic travel may be required.