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

The Senior Director, Pharmacovigilance will lead the safety and risk management strategy for CG Oncology’s investigational and marketed products. This individual will oversee all aspects of pharmacovigilance (PV), ensuring compliance with global regulatory requirements and best practices. In addition to strategic leadership, the role includes operational oversight of case management, signal detection, compliance monitoring, and safety database management. The Senior Director will work cross-functionally to ensure the seamless execution of safety activities within clinical and post-marketing settings.

Location: Remote

Essential Functions

• Develop and oversee CG Oncology’s global pharmacovigilance strategy, ensuring compliance with FDA, EMA, and other international regulatory requirements.
• Lead safety signal detection, risk assessment, and mitigation strategies for CG Oncology’s pipeline and approved therapies.
• Oversee operational PV activities, including case intake, processing, medical review, and submission of safety reports.
• Implement and maintain a robust safety database, ensuring data integrity and compliance.
• Monitor compliance with regulatory requirements, including timely submissions of Individual Case Safety Reports (ICSRs) and periodic safety update reports (PSURs).
• Provide strategic guidance on safety aspects of clinical trial design, execution, and reporting.
• Ensure timely and accurate reporting of adverse events, periodic safety reports, and other regulatory submissions.
• Collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs, Medical Affairs, and Commercial teams, to align safety strategies with overall corporate objectives.
• Develop and maintain Standard Operating Procedures (SOPs) and ensure compliance with pharmacovigilance policies.
• Serve as the primary pharmacovigilance representative in regulatory authority interactions, inspections, and audits.
• Lead and mentor a team of PV professionals, fostering a culture of excellence, accountability, and continuous improvement.
• Partner with external vendors and safety partners to ensure high-quality pharmacovigilance operations and compliance.

Qualifications

• Advanced degree in life sciences, pharmacy (PharmD), nursing (RN), or related field. MD not required.
• Minimum of 10+ years of pharmacovigilance experience in the biopharmaceutical industry, with at least 5 years in a leadership role
• Strong knowledge of global pharmacovigilance regulations, including FDA, EMA, ICH, and other international guidelines.
• Experience in oncology, drug development and post-marketing safety surveillance is highly preferred.
• Proven ability to lead and develop high-performing teams.
• Strong strategic thinking and problem-solving skills, with the ability to influence senior stakeholders.
• Excellent communication and presentation skills, with experience in regulatory interactions.
• Ability to thrive in a fast-paced, innovative, and collaborative environment.

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.