Serve as the medical expert for the team in the management of safety signal, risk management activities, and benefit risk assessments for Replimune products. The Sr. Medical Director, GDS&RM will report to the Head of GDS&RM and will be responsible for the conduct of safety monitoring and accountable for executing product related safety decisions and deliverables for assigned products. This position provides pharmacovigilance expertise to and lead collaborations with external partners as well as with other functions across Replimune, including Regulatory Affairs, Clinical Development, Clinical Operations, Medical Affairs, or the Commercial to ensure that drug safety communications are accurate, complete and consistent.
This position is based in our Woburn office and welcomes hybrid work! Local candidates are expected to be on-site 2 days per week.
ResponsibilitiesKey responsibilities:

• Manage the Medical Directors within the GDS&RM. Support and supervise staff and identify system and resource needs to ensure quality and compliant medical safety evaluation processes
• Oversee the assessment of medical safety information including ICSR’s and aggregate safety data for Replimune’s developmental products
• Lead signal detection and benefit/risk management activities and contribute to the development of pharmacovigilance strategies for monitoring the safety profile of the company’s products
• Lead periodic and ad-hoc SMT and PSRC meetings to review aggregate safety information and signal management for all Replimune products
• Ensure that the safety profiles of Replimune products are accurately and consistently represented in relevant labeling documents, identify and lead updates as required
• Organize and direct liaison cross-functionally with Medical Monitors, Medical writing, Clinical Operations, Data management, Biostatistics, and Regulatory for management of safety reporting in compliance with global and regional regulatory requirements
• Review and provide input on study protocols, statistical analysis plans, safety content of informed consent documents, Investigator and site training documents and presentations
• Contribute to CSRs and analysis of safety tables, figures, and listings and cases from clinical studies
• Support activities related to BLA and other regulatory filings
• Contribute to Regulatory Agency information requests and safety content for regulatory filings, Summary of Clinical Safety and related documents.
• Lead or contribute to the development and/or updates of relevant procedural documents including SOPs, Work Instructions, conventions, forms or templates
• Provide medical safety expertise for internal and external audits and regulatory authority inspections for Pharmacovigilance and ensure that relevant corrective actions are implemented
• Maintain an up-to-date working knowledge of applicable regulatory requirements, guidelines, and industry standards globally.
• Other responsibilities as assigned

QualificationsExperience and skill requirement:

• MD or equivalent degree from an accredited medical school
• At least 4 years Clinical practice experience in either an accredited academic setting or private practice (including hospital based) setting
• At least 8 years’ experience in safety and pharmacovigilance in the bio/pharmaceutical industry, including ICSR review, causality assessment, and aggregate data review
• Expertise in oncology, immunotherapy and with viral vectors or other biologic agents preferred
• Knowledge of GCPs, ICH guidelines and FDA regulations and familiarity with EMA regulations and guidelines, and other international regulatory requirements.
• Knowledge of MedDRA dictionary relevant to AE/SAE coding
• Experience with software-based drug safety systems (e.g. ARIS-G and/or ARGUS)
• Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment.
• Detail-oriented, with good organizational, prioritization, and time management proficiencies.
• Must be able to work on multiple projects simultaneously.
• Ability to prioritize work without much support.
• Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures.
• Proficient in standard computer software (Word, Excel and Power Point)

Location:

• This position is based in our Woburn office and welcomes hybrid work! Local candidates are expected to be on-site 2 days per week.