Orca Bio

Oversee the quality component of the onboarding process for commercial Authorized Treatment Centers on the West Coast. This includes conducting site assessments, managing timelines, and coordinating with internal teams to ensure compliance with quality standards.

Lead the commercial legal function to support the first U.S. product launch, providing strategic advice to Sales, Marketing, and Medical Affairs. Act as the subject matter expert on U.S. healthcare laws and oversee the company's risk-based compliance program.

Serve as the primary liaison between Orca Bio and Authorized Treatment Centers to manage relationships and ensure site readiness. Drive the appropriate use of approved therapies by coordinating logistics and educating healthcare stakeholders.

The Lead Clinical Data Manager oversees all aspects of clinical trial data management from study start-up through database lock. This includes designing CRFs, managing EDC builds, ensuring CDISC compliance, and coordinating data cleaning and reconciliation.