CG Oncology

Compensation

Full Description

Job Description: • Serve as a strategic partner with the Tech Ops and CMC leadership to define regulatory strategies. • Bring hands-on experience to author regulatory submissions within US and Ex-US, coaching and guiding AD/QC staff to author reg submissions. • Work with Tech ops senior leadership to define, develop and execute CGO’s post commercial pathway. • Build sustainable and appropriate organization structure to support CGO future growth from late stage company to a commercial and growing company. • Define and execute the global analytical development strategy across all stages of development, from late-stage clinical through commercial lifecycle management. • Ensure analytical methods are scientifically sound, phase-appropriate, robust, and aligned with regulatory expectations. • Oversee method development, qualification, validation, transfer, and lifecycle management for drug substance and drug product. • Lead and scale Quality Control operations, including in-house and external QC testing activities. • Ensure QC systems meet GMP requirements and remain inspection-ready. • Support regulatory submissions and serve as an analytical SME for health authority interactions. • Build, lead, and mentor a high-performing Analytical Development and Quality Control organization. • Manage external laboratories, CROs, CDMOs, and testing partners. • Collaborate cross-functionally to support tech transfer and commercialization readiness. Requirements: • PhD or MS in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry, or related discipline. • 15+ years of experience in analytical development and/or quality control in biotech or pharma. • Experience supporting late-stage clinical programs, BLA submissions, and commercial readiness. • Deep knowledge of GMP, ICH guidelines, and global regulatory expectations. • Proven experience leading and scaling analytical and QC organizations Benefits: • HIGHLY COMPETITIVE SALARIES • ANNUAL PERFORMANCE/MERIT REVIEWS • ANNUAL PERFORMANCE BONUSES • EQUITY • SPECIAL RECOGNITION • 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