Jobs at Cogent Biosciences

Lead and oversee global clinical trials from planning through execution, managing CROs and vendors, tracking study metrics and risks, supporting protocol and study documentation, performing site activities and monitoring, ensuring regulatory compliance (GCP/ICH/FDA), and contributing to clinical operations strategy and process improvements.

Provide scientific and strategic statistical leadership for oncology clinical programs from early development through pivotal trials and regulatory submissions. Design protocols, define endpoints and estimands, perform sample size and interim analyses, author SAPs and study reports, support NDA/BLA interactions, oversee CRO statistical work, and help build Biometrics capabilities and best practices across cross-functional teams.

Lead transparency reporting and third-party data management, support compliance risk assessment and monitoring, conduct live and desktop monitoring, build compliance data analytics and dashboards, produce reports and presentations, and support compliance-related projects for the companys commercial launch.

Lead day-to-day commercial channel operations for product launch, overseeing 3PL and specialty distributor relationships, inventory and returns management, order-to-cash and chargebacks, monitoring EDI/product movement data, and supporting account planning and cross-functional collaboration to ensure product availability and patient access.

Lead GCP quality assurance for clinical development, plan and conduct GCP audits of sites/CROs/vendors, ensure inspection readiness, manage deviations/CAPAs, maintain quality systems, support regulatory submissions, and mentor junior QA staff.

Lead analytical development activities across development and commercial programs, overseeing method development/validation/transfer, analytical reporting, stability programs, regulatory CMC documentation, investigations (OOS/OOT), and collaboration with Quality, Regulatory, and external CDMOs to ensure compliant, timely analytical deliverables.