Remote AVP, CMC Strategy & Portfolio Leadership

CG Oncology, Inc.; Dallas (TX); Remote; USD 180.000 - 240.000; Vollzeit

Zusammenfassung

CG Oncology, Inc. seeks an Associate Vice President to lead the CMC Strategy and Portfolio Management. The role reports to the Chief Technical Officer and shapes CMC plans for BLA readiness, PPQ campaigns, and late-stage development.

You will partner closely with technical teams, regulators, CMOs, and external consultants to translate strategy into executable programs. The AVP will drive integrated CMC timelines, risk mitigation, and governance for CGO’s products, ensuring alignment with

Qualifikationen

• Ten years in business/operational leadership with at least five years at senior/executive level.
• Experience managing collaborations with outsourced vendors (labs, CROs, CMOs).
• Experience in CMC, Quality and Analytical Development.
• Biologics late-stage development/BLA-enabling activities prior to PPQ, including risk assessment.

Aufgaben

• Lead the CMC Product and Portfolio Strategy function and report to the CTO.
• Oversee CMC strategy development, PPQ campaigns, and BLA readiness.
• Coordinate with PM, QA, Regulatory, Finance, and external CMOs to align milestones.
• Provide strategic CMC leadership across global regulatory submissions and lifecycle management.
• Ensure continuity of drug supply for clinical and commercial needs.

Kenntnisse

Executive leadership

Strategic planning

Cross-functional leadership

Regulatory liaison

Ausbildung

Bachelor’s degree in Life Sciences or Health Care Management

Jobbeschreibung

CG Oncology, Inc. seeks an Associate Vice President to lead the CMC Strategy and Portfolio Management. The role reports to the Chief Technical Officer and shapes CMC plans for BLA readiness, PPQ campaigns, and late-stage development.

You will partner closely with technical teams, regulators, CMOs, and external consultants to translate strategy into executable programs. The AVP will drive integrated CMC timelines, risk mitigation, and governance for CGO’s products, ensuring alignment with