Lead the planning and execution of late-stage clinical development studies to move programs through pivotal trials toward regulatory approval and launch. Manage clinical deliverables including protocols and INDs while collaborating with cross-functional teams and health authorities.
Erasca
6 Remote Job Openings at Erasca
Lead GCP activities and provide strategic oversight for QA operations supporting clinical development programs and regulatory submissions. Manage audit programs, lead regulatory inspections, and ensure compliance across GCP, GLP, GVP, and CDx frameworks.
Lead and participate in regulatory activities for IND/CTA development and maintenance to support clinical trials and future MAA/NDA/BLA filings. Provide CMC regulatory support through QC review of submission components and collaborate cross-functionally to ensure compliance with global regulatory requirements.
Manage global Phase 1-3 oncology clinical trials from concept to completion, ensuring compliance with ICH-GCP and regulatory requirements. Oversee clinical vendors, CROs, budgets, and timelines while coordinating site activation and trial material distribution.
Provide medical leadership and oversight for late-stage clinical trials and registration-enabling trials in solid tumor indications. Lead the late clinical development function, managing strategy, protocol development, and regulatory filings while collaborating with the CMO.
Lead and oversee biometrics activities across all programs from IND-enabling to registration and launch, managing Biostatistics, Statistical Programming, and Clinical Data Management. Represent the biometrics function on the leadership team and manage interactions with regulatory agencies and health authorities.