Teams at ORIC Pharmaceuticals, Inc.

Lead global pharmacovigilance operations for late-stage and launch-readiness oncology programs. Oversee ICSR processing, safety reporting, DSURs, RMPs/REMS readiness, regulatory submissions, vendor oversight, signal detection, and cross-functional safety governance.

Lead CMC regulatory strategy and global submissions for oncology products. Manage preparation and responses for IND/CTA/NDA/MAA packages, author Module 2/3 and eCTD documents, assess manufacturing changes, mitigate regulatory risks, and collaborate cross-functionally with development, quality, clinical, and regulatory teams.

Lead analytical development and product characterization across drug development stages. Design and execute experiments, develop and validate analytical methods, oversee CDMO/CRO activities, author regulatory documentation, and provide technical leadership and project management to ensure timely, compliant delivery of analytical data.