Associate Vice President - CMC Strategy and Portfolio Management

March 19

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $285k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

👔 Vice President

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CG Oncology

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CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing innovative oncolytic immunotherapies for patients with bladder cancer. The company's primary investigational product, cretostimogene grenadenorepvec, aims to provide a bladder-sparing therapeutic option, enhancing the quality of life for afflicted patients. With ongoing clinical studies highlighting the potential benefits of their therapies, CG Oncology strives to address the unmet needs in bladder cancer treatment.

Immuno-Oncology

51 - 200 employees

Founded 2010

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

📋 Description

• Lead the CMC Product and Portfolio Strategy function • Report directly to the Chief Technical Officer • Translate business strategy and vision into CMC plans for execution • Bring technical issues to the executive team • Influence decision-making and overall strategy • Define CMC strategy and represent critical CMC milestones • Work closely with technical teams, Project Management, Finance, Quality • Ensure CMC for Cretostimgene is progressing in alignment with corporate goals and timelines • Develop integrated CMC strategy and create alignment of activities in multiple functions • Ensure execution of key BLA/MAA readiness activities • Manage collaborations with external consultants, PM and CMOs • Provide oversight and strategic CMC leadership • Partner with CMC and regulatory teams for strategic support • Limit domestic and international travel to 10-20% of the time

🎯 Requirements

• Bachelor’s degree in Molecular Biology, Cellular Biology, Chemistry, Virology, Immunology, Public Health, Health Care Management or related field • 10 years in business/operational leadership related occupation • 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

🏖️ Benefits

• 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