ASSOCIATE VICE PRESIDENT

Company: CG Oncology, Inc.
Location: Irvine
Posted on: April 4, 2025

Job Description:

COMPANY: CG Oncology, Inc.

All the relevant skills, qualifications and experience that a successful applicant will need are listed in the following description.

POSITION: Associate Vice President, CMC Strategy and Portfolio Management WORK LOCATION: 400 Spectrum Center Dr.

Irvine, CA 92618 telecommuting permitted from any U.S.

location JOB DUTIES: Lead the CMC (Chemistry, Manufacturing, and Controls) Product and Portfolio Strategy function, and report directly to the Chief Technical Officer.

As part of our senior leadership, the AVP will translate business strategy and vision into CMC plans for execution, bring technical issues to the executive team, and influence decision-making and overall strategy to ensure success.

This role is a key component for defining CMC strategy and representing all aspects of critical CMC milestones.

The role works closely with the technical teams, Project Management, Finance, Quality, and other relevant governance forums to ensure that all aspects of CMC for Cretostimgene are progressing in alignment with corporate goals and timelines.

The duties of the position include the following: Develop integrated CMC strategy and create alignment of activities taking place in multiple functions.

Ensure proper execution of key BLA/MAA readiness activities such as performance qualification (PPQ) for drug product and timely Agency communications to ensure alignment of CMC data package.

Work closely with external consultant, PM and our CMOs to oversee all the CMC activities related to DDM.

Be the point of contact for CG Oncology to navigate all the late -stage activities for DDM, leading all the way to BLA submission including Process Characterization, PPQ campaign and scale up.

Work closely with technical teams within CG Oncology to define and evolve CMC strategy for bringing on new or managing existing contract manufacturing organizations (CMOs) for activities related to tech transfer, analytical method development and qualification, comparability and managing impact on supply continuity.

Partner with the CMC and regulatory teams to provide strategic support and expertise on the implementation and execution of Health Authority commitments.

Be the contact person from Tech Ops to effectively communicate with regulatory agencies (in collaboration with Regulatory) for all the IRs, submissions and asks.

Provide oversight and strategic CMC leadership while leveraging global regulatory CMC knowledge for all stages of product and process development including identifying innovative paths to accelerate overall BLA readiness.

Oversee and train cross-functional teams on authoring and reviewing regulatory CMC dossiers.

Collaborate with functional leads to identify risk and develop mitigation plans, enable effective and timely decisions by the leadership team.

nt while balancing the global requirements in collaboration with the PM, developed integrated CMC timelines and critical milestones for each project.

Partner with CMC functional heads to ensure quality, technical development and manufacturing activities are planned and executed to meet global requirements for late-stage development and marketing authorization.

Lead Tech Ops efforts to build interface between clinical development, supply chain and manufacturing to ensure uninterrupted drug supply for clinical and commercial needs.

Develop, monitor, and report performance indicators to highlight progress, risks, and mitigation strategies.

Partner with CMC functional heads and facilitate CMC budget development to meet enterprise goals.

Assess and revise strategic plans across all products as business objectives evolve.

Take relevant decisions to direct the product team or, for decisions outside the team's scope, escalate and steer through the appropriate governance mechanisms.

Identify opportunities to improve decision making and escalation process, establish subgroups with broad technical backgrounds and experience to resolve issues and unexpected challenges Domestic and international travel 10-20% of the time.

100% telecommuting permitted from any US location.

REQUIRED QUALIFICATIONS: Education: Bachelor's degree in Molecular Biology, Cellular Biology, Chemistry, Virology, Immunology, Public Health, Health Care Management or related field Experience: 10 years in business/operational leadership related occupation Experience must include: 10 years in progressively responsible business/operational leadership roles with 5 years of experience at senior and/or executive leadership level Experience successfully managing and maintaining collaborations with outsourced vendors such as labs, CROs, CMOs, etc.

Experience in CMC, Quality and Analytical Development Experience with Biologics in late-stage development/BLA-enabling activities such as Risk Assessment, Process Characterization, Process Validation and Assay Validation prior to PPQ runs, and commercial launch.

Experience with Virus Products/Vaccine Offered Wage: $285,000 Send resume to careers@cgoncology.com

Keywords: CG Oncology, Inc., Irvine , ASSOCIATE VICE PRESIDENT, Executive , Irvine, California