Medical Director, Global Drug Safety

Replimune•Woburn, MA

5d•Hybrid

About The Position

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.

Requirements

MD, DO or equivalent non-US medical degree.
Strong knowledge of general medicine and clinical medical practice (MD, DO, MBBS, or equivalent).
Strong understanding of disease pathophysiology and medical therapies.
Working knowledge of GCP, ICH guidelines, and global regulatory requirements.
Minimum of 5 years of experience in Drug Safety/Pharmacovigilance or as a Medical Monitor; experience in oncology and immunotherapy is preferred.
Experience in the evaluation, analysis, and interpretation of safety data.
Demonstrated ability to manage multiple priorities and responsibilities.
Strong written and verbal communication skills.
Sound judgment and decision-making abilities, including the timely identification and communication of relevant safety issues and concerns to Medical Safety Management.
Experience reviewing AEs/SAEs, Investigator's Brochures, protocols, Clinical Study Reports, informed consent documents, and other safety-related materials.
Strong attention to detail.

Nice To Haves

Prior NDA/BLA submission experience and oncology experience are preferred.

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, assume primary responsibility for and/or chair one or more Safety Teams for assigned products.
Participate in Risk Management Strategy activities.
Perform other duties as assigned by management.
Perform other related duties as necessary to meet the ongoing needs of the GDS&RM organization.