Medical Director, Global Drug Safety at Replimune Group in Woburn

Job description

Overview Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it. At Replimune, we live by our values: United: We Collaborate for a Common Goal. Audacious: We Are Bold. Dedicated: We Give Our Full Commitment. Candid: We Are Honest With Each Other. People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves. Join us, as we reshape the future. Summary of job description: The Medical Director, GDS&RM will perform individual and aggregate case reviews and provide broad support of activities requiring medical safety input for assigned products, both pre- and post-approval. The Medical Director, GDS&RM will support and/or lead periodic safety signaling reviews and meetings. This position will also participate, to varying degrees, on clinical teams/programs and other intra- and interdepartmental activities and initiatives, as needed. This position is based in our Woburn office and welcomes hybrid work! Local candidates are expected to be on-site a minimum of 2 days per week. Key responsibilities · Provide timely and scientifically sound medical review of individual case safety reports from clinical trials and post-marketing sources. · Serve as the GDS&RM medical expert for SAE reconciliation, coding reviews, and assessment of the expectedness of serious adverse reactions (SARs). · Represent the department as the medical safety lead on cross-functional study and program teams for assigned products and studies, providing expert guidance on safety matters and issues. · Represent the department as the subject matter expert (SME) during audits and inspections. · Participate in protocol development, specifically regarding the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans. · Conduct safety signal detection activities, including monitoring, evaluation, interpretation, management, and communication of safety information to the Safety Surveillance/Safety Management Team for assigned products. This includes leading ongoing and cross-functional benefit-risk assessments and related actions, as well as authoring and updating benefit-risk documents for assigned products and development compounds. · Collaborate closely with Clinical Medical Monitors on ongoing safety monitoring and participate in the analysis of safety data from ongoing and completed clinical trials, including contributions to Clinical Study Reports. · Work closely with the Medical Affairs team on post-approval product safety reports, investigator-sponsored trials (ISTs), and compassionate-use programs. · Oversee the appropriate review of all safety data from various sources (e.g., preclinical studies, clinical trial data, and literature) throughout the development process for assigned products. · Author Safety Assessment Reports and other safety-related documents and regulatory responses in collaboration with the Senior Director and Vice President, GDS&RM. · Contribute to the preparation and review of periodic reports (e.g., IND Annual Reports, DSURs, PSURs, and CSRs). · Review and provide medical input, as needed, for key study-related documents, including Investigator's Brochures (IBs), Informed Consent Forms (ICFs), and IDMC Charters. · Participate in departmental development activities, including the creation and revision of SOPs and Work Instructions. · Provide medical guidance to staff regarding best practices for the collection, evaluation, and processing of adverse event reports. · Contribute to partner and affiliate agreements and interactions, as needed. · As directed by management,