3h ago
Senior Director, Compliance
Redwood City, California, United States
full-timedirectorbiotechnology
Description
You will provide enterprise-wide compliance leadership and support across the company, advising on healthcare, research, manufacturing, export controls, trade, and corporate compliance. You'll embed compliance into daily operations and partner with senior leaders and cross-functional teams to support the company's growth as a commercial-stage oncology organization.
Requirements
- Enterprise-wide compliance leadership experience in pharmaceutical or biotech industry
- Expert knowledge of healthcare compliance laws (Anti-Kickback, False Claims Act, OIG, Sunshine Act) and export controls
- Experience implementing risk-based compliance programs aligned with DOJ guidance
- Strong advisory skills to senior leaders and cross-functional teams
- Ability to embed compliance into daily operations in a growing organization
Responsibilities
- Support VP, Compliance in maintaining the Compliance Committee and integrating compliance into business operations
- Provide compliance oversight and advisory for conflicts of interest, third-party risk, anti-bribery, data privacy, records management, and ethical practices
- Guide export control laws (EAR, OFAC) and trade compliance for cross-border activities, research collaborations, and supply chain
- Provide healthcare compliance support for Commercial, Marketing, Medical Affairs on Anti-Kickback, False Claims Act, OIG, Sunshine Act
- Develop and enforce compliance policies, procedures, and controls across corporate, R&D, clinical, manufacturing, and commercial functions
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