Director, Clinical Scientist

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.