Senior Director, Compliance — Biotech Launch (Remote)

CG Oncology; United States; On-site; USD 180,000 - 280,000; Full time

Benefits offered by this job

Fully remote work environment

Annual performance bonuses

Equity

401K with company match

Health insurance

Job summary

CG Oncology, Inc. is seeking a Senior Director, Compliance to lead our growing program as we transition toward a commercial organization and the launch of our first product.

The role reports to the General Counsel & Chief Compliance Officer and partners with Commercial, Medical Affairs, Regulatory, Finance, HR and Legal to implement governance, risk management, training, and monitoring across the enterprise.

Qualifications

• Bachelor’s degree required; advanced degree preferred (JD, MBA, MPH, MS) for senior leadership.
• 10+ years of compliance experience within biotechnology or pharmaceuticals.
• Proven ability to build or significantly enhance compliance programs.
• Strong knowledge of FDA regulations, OIG guidance, Anti‑Kickback Statute and related laws.

Responsibilities

• Lead building and launch of the enterprise-wide compliance program.
• Advise cross‑functional leaders on healthcare compliance risks and requirements.
• Oversee monitoring, auditing, investigations, and third‑party oversight.
• Embed compliance into everyday decision‑making and strategic initiatives.
• Evaluate and implement technology, analytics, and AI-enabled capabilities for monitoring and risk management.

Skills

FDA regulations

Compliance leadership

Risk assessment

Training programs

Investigations

Cross-functional collaboration

Education

Bachelor’s degree

Advanced degree (JD, MBA, MPH, MS)

Tools

GxP systems

AI in compliance

Job description

CG Oncology, Inc. is seeking a Senior Director, Compliance to lead our growing program as we transition toward a commercial organization and the launch of our first product.

The role reports to the General Counsel & Chief Compliance Officer and partners with Commercial, Medical Affairs, Regulatory, Finance, HR and Legal to implement governance, risk management, training, and monitoring across the enterprise.