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Director, Clinical Scientist

Replimune

Role: Lead clinical development as a Clinical Scientist/Director to support Replimune's immuno-oncology programs, ensuring successful execution of clinical trials and regulatory deliverables. Responsibilities: develop clinical strategies, author and review key documents (protocols, IBs, reports, regulatory submissions), provide scientific guidance during study design, conduct, and data analysis; build relationships with investigators, vendors, and internal teams; contribute to process improvements and resource planning; represent clinical programs externally at investigator meetings and advisory boards. Requirements: MD, PharmD, or PhD with 10+ years in biotech/pharma, extensive experience in clinical oncology, and involvement across multiple trial phases from start-up to reporting; expertise in global study design, GCP, ICH guidelines. Preferred: experience managing cross-functional teams, developing SOPs, and familiarity with clinical IT solutions. High-Value: oncology focus, clinical trial leadership, regulatory documentation, global clinical operations, approximately 25% travel. WorkSetup: Office-based in Woburn, MA, with travel. #J-18808-Ljbffr

Vacancy posted 5 days ago
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