Sr. Manager Clinical Scientist

Replimune is revolutionizing cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response. This role ensures the successful execution of clinical development programs and deliverables in partnership across the organization, with external vendors, and with external academicians and collaboration partners.

The Sr. Manager Clinical Scientist, reporting to the (Associate) Director/Sr. Director Clinical Scientist, works closely in a matrix with the Medical Director and other functional representatives to assure that activities are executed within expected scope, compliance, budget, and timelines. The individual supports the establishment and growth of Clinical Development functions to assure best-in-class global capabilities and execution.

Key Responsibilities:

• Facilitate and execute the creation, update, and/or review of key clinical and regulatory documents, including:

• Protocol concepts, synopses, protocols, and amendments
• Informed consent documents
• Investigator Brochures
• Clinical study reports
• Abstracts, posters, and manuscripts
• Clinical sections of INDs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports
• Clinical study supporting documentation and processes, e.g., charters for (independent) safety data monitoring or steering committee, study-specific management plans and manuals, SOPs, etc.

• Support all clinical and scientific aspects of the design, implementation, conduct, analysis, interpretation, and documentation of clinical studies. Partner with relevant functional areas for successful implementation and execution of clinical studies. Specific tasks include:

• Provide clinical and scientific expertise for selection of investigator/site staff and vendors
• Train internal colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and/or clinical protocol
• Provide scientific and medical support throughout the conduct of a clinical trial; respond to clinical questions from sites, IRBs/IECs, Health Authorities, and CROs
• Review, query, and analyze clinical trial data
• Partner with the Medical Director on medical monitoring, patient eligibility, and study treatment-related questions, in cooperation with the CRO or directly with the study investigator

• Present clinical trial data, both internally and externally
• Create clinical study or program-related slide decks for internal and external use
• Represent a clinical study or development program on one or more teams or sub-teams
• In collaboration with the Medical Director/Medical Monitor, build and maintain KOL/investigator networks; organize and present at KOL advisory boards and investigator meetings, engage advocacy groups
• Contribute to or perform therapeutic area/indication research and competitor analysis
• Build strong relationships with internal experts
• Develop, track, execute, and report on goals and objectives
• Be accountable for compliant business practices