Provide medical direction and high-quality scientific and clinical knowledge to guide the strategy and execution of the lung cancer program and contribute to clinical decision making across the Erasca portfolio. Participate in building and maintaining a culture of rigorous data-driven decision making.
Support GMP CMC operations, including review/approval of Manufacturer master and executed batch records, Certificates of Analysis, and associated analytical data of GMP products intended for human clinical use (Drug Substance, Drug Product, and Investigational Medicinal Product), to include biologic and small molecule products. Supports GMP/CMC Quality by Design (QbD), risk assessments, and process performance qualification (PPQ)/process validation activities
