About CG Oncology, Inc.

Are you ready to make a difference in the world and become part of our patient-centered team that is focused on Attacking Bladder Cancer for a Better Tomorrow? At CG Oncology, we believe that by having exceptionally talented individuals on our team who share our passion and enjoy working together, we can truly achieve our Vision and Mission to benefit patients around the world.

Every day we are making significant advancements across our multiple pipelines and are growing rapidly to meet the needs of our patients who cannot afford to wait to benefit from our novel immunotherapies. Please review this job posting and our Values and if they resonate with you and are what you expect from your organization and team, then we would like to hear from you.

About the role

• 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:

Location: 400 Spectrum Center Dr. Irvine, CA 92618 / telecommuting permitted from any U.S. location

Essential Functions

• 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.
• Navigate and work collaboratively in a matrix environment 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.

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

Please note that CG Oncology does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Any resumes or client information submitted to our careers page or any employee of CG Oncology by any search firm or agency without an applicable contract in place will become the property of CG Oncology and no fee(s) will be paid.

Total Rewards

CG Oncology offers very competitive and comprehensive Total Rewards, helping to support and reward our global team of high-performing employees focused on developing bladder-saving therapeutics for patients afflicted with bladder cancer.

• HIGHLY COMPETITIVE SALARIES   
• ANNUAL PERFORMANCE/MERIT REVIEWS
• ANNUAL PERFORMANCE BONUSES
• EQUITY
• SPECIAL RECOGNITION

Well-Being Benefits

In addition to our Total Rewards, CG Oncology offers a variety of Well-Being Benefits to meet the majority of the needs of our unique and growing workforce.  These benefits are designed to support our team to achieve a healthy balance between work and their personal lives to remain refreshed, engaged, and creating an environment where each person can find a deeper meaning and purpose in their work.

Well-Being Benefits eligibility begins the 1st of the month after hire.  While a majority of these benefits are for our US-based workforce, we continue to assess comparable levels of benefits for our international team members that are aligned with country-specific regulations and their national programs offered.

• FULLY REMOTE WORK ENVIRONMENT
• REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off
• HOLIDAYS –In 2025 we will observe 14 holidays
• RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary
• HEALTH (MEDICAL, DENTAL, VISION) – PPO & HDHP – Cigna/Principal
• HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC
• ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans
• LIFE INSURANCE – Company Paid 1 x base salary + Voluntary Plans
• ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More

CG Oncology is an Equal Opportunity Employer:

All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.  At CG Oncology, we are building a community of intelligent and passionate team members that share our Vision, Mission and Values, and while the biotechnology space can feel limited in BIPOC, non-binary and even female representation, we endeavor to make hiring decisions that will continue to grow and support our team in the direction of maintaining cultural diversity and sustainability.