Senior Manager, Clinical Scientist

🔥 7 hours ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $159k - $205.5k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

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Replimune

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2015

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

💰 $140M Post-IPO Equity - Replimune Group on 2024-11

Biotechnology • Healthcare • Pharmaceuticals

Replimune is a clinical-stage biotechnology company focused on developing a new class of oncolytic immunotherapies intended to activate powerful, durable systemic anti-tumor immune responses. The company’s approach is to kill tumors locally, alter the tumor microenvironment, and ignite a full-body, tumor-specific immune response. Replimune is conducting clinical programs evaluating the safety and effectiveness of its investigational therapies in a range of solid tumors, both as single agents and in combination with other immunotherapies.

📋 Description

• 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

🎯 Requirements

• Minimum of a Bachelor's degree required • Minimum of 3+ years of experience and success within the function in other biotech / pharmaceutical companies • 1-2 years in the oncology therapeutic area • Previous participation in an Early/Late clinical development program is essential • Clinical oncology experience required for Late Phase; preferred for Early Phase • Knowledge of GCP and ICH Guidelines • Flexibility to work with colleagues in a global setting • Ability to travel approximately 25% for work • Knowledge of industry standard Clinical Development IT solutions • Problem solving and risk-mitigation skills • Ability to work independently and build working relations throughout the organization and with business partners • Strong time management and organizational skills • Ability to manage multiple projects in a fast-paced environment • Skilled in computer-based tools including Word, PowerPoint, and Excel • Advanced degree such as PharmD, PhD, or MD preferred

🏖️ Benefits

• Annual performance incentive bonus • New hire equity • Ongoing performance-based equity • Medical insurance • Dental insurance • Vision insurance • 401k match • Flexible time off • Paid holidays, including year-end shutdown