About the roleWe are seeking an experienced and strategic Senior Director, Compliance to be an integral part of the team responsible for building, implementing, and leading the company's compliance program as we transition from a clinical-stage biotechnology company to a commercial organization preparing for the launch of our first product.
Reporting directly to the General Counsel & Chief Compliance Officer, this individual will serve as the operational leader responsible for executing a scalable compliance infrastructure that supports the company's commercial strategy while ensuring adherence to healthcare laws, FDA regulations, industry standards, and ethical business practices.
The Senior Director will partner closely with Commercial, Medical Affairs, Market Access, Regulatory Affairs, Finance, Human Resources, and Legal leadership to implement compliance governance, risk management processes, monitoring programs, training initiatives, and compliance controls. Following implementation, this leader will oversee the ongoing management, effectiveness, and continuous improvement of the compliance program.
This role offers a unique opportunity to participate in building a best-in-class compliance function from the ground up while serving as a trusted advisor to executive leadership and helping shape the company's culture of integrity and accountability.
Essential FunctionsBuild and Launch the Compliance Program
- Partner with the General Counsel & Chief Compliance Officer to develop the company's compliance strategy and operating model.
- Assist with the design and implementation of a comprehensive healthcare compliance program supporting commercial launch readiness.
- Establish compliance policies, procedures, governance structures, and reporting frameworks.
- Develop compliance risk assessment methodologies and enterprise monitoring programs.
- Create investigation, escalation, corrective action, and issue-management processes.
- Build compliance committee structures and reporting processes for executive leadership.
Strategic Business Partnership
- Advise cross-functional leaders on healthcare compliance risks and requirements.
- Support commercialization activities, including promotional review, speaker programs, patient support programs, field force interactions, grants, and third-party engagements.
- Provide practical, business-oriented guidance that enables responsible growth while maintaining regulatory compliance.
Compliance Culture and Training
- Develop and implement enterprise-wide compliance training and communication programs.
- Promote a culture of ethics, transparency, and accountability.
- Establish mechanisms for reporting, investigating, and resolving compliance concerns.
- Partner with business leaders to embed compliance into everyday decision-making.
Monitoring, Auditing, and Risk Management
- Lead auditing, monitoring, and testing activities across the organization.
- Conduct and oversee investigations and remediation efforts.
- Manage third-party compliance oversight programs.
- Identify emerging compliance risks and recommend mitigation strategies.
Technology and Continuous Improvement
- Evaluate and implement compliance technologies, analytics tools, automation solutions, and AI-enabled capabilities that enhance monitoring, reporting, and risk management.
- Ensure the responsible use of AI and emerging technologies within compliance operations.
Qualifications- Bachelor's degree required; advanced degree (JD, MBA, MPH, MS, or equivalent) preferred
- 10+ years of compliance experience within biotechnology or pharmaceuticals.
- Demonstrated success building or significantly enhancing compliance programs in biotechnology or pharmaceutical environments.
- Strong knowledge of FDA regulations, OIG guidance, Anti-Kickback Statute, Sunshine Act requirements, healthcare fraud and abuse laws, and related compliance frameworks.
- Experience leading investigations, monitoring activities, auditing programs, and compliance risk assessments.
- Ability to influence senior leaders and drive cross-functional alignment.
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 RewardsCG 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 BenefitsIn 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 2026 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
