The Associate Director supports GMP clinical manufacturing operations by reviewing batch records, analytical data, and quality events to ensure regulatory compliance. They also provide quality oversight for clinical supply chains and manage interactions with contract manufacturers and vendors.
Erasca
8 Remote Job Openings at Erasca
The role involves driving the overarching medical strategy and execution for GI cancers, with a specific focus on pancreas cancer. The individual will lead cross-functional teams in clinical development, evidence generation, and KOL engagement while managing medical affairs activities.
The Director/Sr Director will lead the overarching medical communications strategy, including content development, education, and awareness initiatives across molecules and disease states. They will also manage cross-functional execution of scientific platforms, congress planning, and insight collection initiatives.
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.
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.
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.