Replimune

Medical Director

• Refine and ensure successful implementation of Replimune’s scientific communication platform and medical communication plan
• Develop and review abstracts, publications, congress presentations, monographs, and related content
• Ensure medical and scientific content accuracy and strategic alignment
• Develop, manage, and track scientific communications plans
• Ensure compliance with publication-related policies and procedures
• Remain current on the latest science and data in the field
• Create, collect, and disseminate actionable, business-relevant scientific insights to internal stakeholders and key customer segments
• Support critical product launches
• Develop in-depth therapeutic knowledge of disease, epidemiology, products, and competitor products
• Serve as a resource to stakeholders outside Medical Affairs
• Collaborate closely with members of other internal teams
• Provide information and input for product and competitor insights, medical product plans, deliverables, new business assessments, and other business activities
• Serve as an authoritative source of medical and scientific expertise
• Oversee collection and storage of relevant scientific information, including literature repositories and Replimune data
• Perform other duties as assigned

Director, Medical Publications and Scientific Communication

Clinical Research

• Ensure successful execution of clinical development programs and deliverables in partnership across the organization, with external vendors, academicians, and collaboration partners
• Work in a matrix with the Medical Director and functional representatives to execute activities within scope, compliance, budget, and timelines
• Support establishment and growth of Clinical Development functions and global capabilities
• Facilitate and execute creation, updating, and review of clinical and regulatory documents, including protocols, informed consents, Investigator Brochures, clinical study reports, publications, IND clinical sections, annual reports, safety update reports, charters, management plans, manuals, and SOPs
• Support clinical and scientific aspects of clinical study design, implementation, conduct, analysis, interpretation, and documentation
• Provide clinical and scientific expertise for investigator/site staff and vendor selection
• Train internal colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and/or clinical protocol
• Provide scientific and medical support throughout clinical trials and respond to 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
• Present clinical trial data internally and externally
• Create clinical study and program-related slide decks
• Represent clinical studies or development programs on teams or sub-teams
• Build and maintain KOL/investigator networks; organize and present at KOL advisory boards and investigator meetings; engage advocacy groups
• Conduct or contribute to therapeutic area/indication research and competitor analysis
• Build relationships with internal experts
• Develop, track, execute, and report on goals and objectives
• Ensure compliant business practices

Senior Manager, Clinical Scientist

• Report to the VP or Executive Director of Early Clinical Development
• Ensure successful execution of clinical development programs and deliverables across the organization, with external vendors, academicians, and collaboration partners
• Jointly develop clinical program strategy and ensure activities are delivered within scope, compliance, budget, and timelines
• Help establish and grow Clinical Development functions and global capabilities
• Collaborate with clinical development, clinical operations, data management, safety/pharmacovigilance, regulatory, biometrics, translational medicine, and program leadership
• Facilitate, author, update, and review clinical and regulatory documents, including protocols, informed consents, Investigator Brochures, clinical study reports, abstracts, posters, manuscripts, INDs, NDAs, annual reports, and safety update reports
• Generate Early Clinical Development Plans and program strategy
• Lead clinical and scientific aspects of clinical study design, implementation, conduct, analysis, interpretation, and documentation
• Provide expertise for investigator and vendor selection
• Train internal colleagues, CRO staff, and study site staff on therapeutic areas, molecules, and clinical protocols
• Provide scientific and medical support throughout clinical trials and respond to questions from sites, IRBs/IECs, Health Authorities, and CROs
• Review, query, and analyze clinical trial data
• Serve as medical monitor or partner with medical directors on medical monitoring, patient eligibility, and treatment-related questions
• Interpret and present clinical trial data internally and externally
• Create clinical study and program slide decks
• Represent clinical studies or development programs on teams and sub-teams
• Build and maintain opinion leader and investigator networks; organize advisory boards and investigator meetings; engage advocacy groups
• Conduct or contribute to therapeutic-area research and competitor analysis
• Build relationships with internal experts
• Identify process improvements, best practices, and optimized standards and processes
• Identify organizational resource needs, including staff, budget, and systems
• Develop, track, execute, and report goals and objectives
• Support budget planning and management
• Manage and mentor Clinical Scientists and ensure training and responsibilities are met
• Ensure compliant business practices
• Perform other duties as assigned

Director, Medical Publications and Scientific Communication

Senior Manager, Clinical Scientist

Senior Director, Clinical Scientist