Senior Director, US Compliance

The Opportunity:

The Sr. Director, US Compliance will serve as the lead compliance business partner in support of the company’s planned US commercialization activities for non-small cell lung cancer (NSCLC). The Sr. Director will partner with a range of business functions, serve as a trusted resource for compliance guidance, and ensure launch teams successfully navigate the compliance landscape. This role requires a firm understanding of pharmaceutical best practices and industry requirements, as well as the passion and ability to build relationships with a diverse set of teams all working to revolutionize treatments for patients. This position will report to the VP, US Compliance.

This position will be based out of Redwood City, CA on a hybrid basis.

Essential Duties and Responsibilities will include:

The Sr. Director, US Compliance will collaborate and build strong partnerships with several cross-functional stakeholders to help enable commercialization and growth within the NSCLC space.  Areas of focus include:

• Serve as the strategic compliance advisor to Commercial, Medical Affairs, Market Access, Patient Services, and other field-facing functions by proactively identifying compliance risks, enabling compliant business solutions, and embedding compliance into key business decisions throughout commercialization and product launch.

• Lead ongoing compliance risk assessments for field-facing activities in the NSCLC space, identify emerging risks, and develop practical mitigation strategies in partnership with business leaders and others in Compliance.

• Represent Compliance on commercialization committees, launch teams and workstreams, and other strategic and tactical decision-making forums, ensuring compliance considerations are incorporated into strategic business decisions.

• Serve as lead compliance reviewer and advisor on NSCLC initiatives, ensuring timely, practical, and risk-based guidance is incorporated into business activities.

• Lead the design, development, and delivery of engaging, risk-based compliance training to NSCLC business teams, ensuring compliance risks are appropriately mitigated while fostering a culture of ethics and compliance.

• Partner with others in Compliance and business stakeholders to develop and continuously improve compliance policies, processes, and other governance controls.

• Develop, manage, and conduct monitoring and auditing activities to identify and mitigate compliance risks.

• Champion a culture of ethics, integrity, and accountability by promoting open communication, encouraging appropriate escalation of concerns, and reinforcing ethical decision-making.

• Serve as strategic advisor in continuously improving the Compliance program by proposing enhancements, monitoring industry trends and best practices, and bringing the field perspective to discussions.

• When appropriate given the business growth, build a team of compliance professionals to support the growing NSCLC commercialization field activities.

• Partner closely with the Healthcare Law team to ensure consistency between legal interpretation and compliance operations.

Additional Responsibilities and Role Evolution

The responsibilities outlined in this job description are intended to describe the general nature and level of work performed by the individual in this role and are not intended to be an exhaustive list of all duties, responsibilities, or qualifications.

The Sr. Director, US Compliance will be expected to take on additional assignments, projects, and responsibilities as needed to support the Compliance team and broader business objectives. Responsibilities may change, expand, or shift over time based on organizational priorities, business growth, process improvements, technology implementations, and evolving legal or regulatory requirements.

The successful candidate will demonstrate flexibility, adaptability, and a willingness to contribute beyond the core responsibilities of the position, partnering collaboratively across functions to support the continued success and growth of the company.

Required Skills, Experience and Education:

• Bachelor’s degree.

• 10+ years of healthcare compliance experience in pharmaceuticals or biotechnology; in-house compliance experience strongly preferred.

• In-depth understanding of US healthcare laws and guidance, including the OIG guidelines, PhRMA Code, US Sunshine Law, Anti-Kickback Statute, False Claims Act, FDA promotional regulations, and the FCPA.

• Experience as a compliance business partner with familiarity with the compliance risks associated with relevant business activities.

• Significant experience supporting pre-commercial pharma or biotech companies through launch planning and commercial product launch.

• Demonstrated ability to build strong partnerships and collaborate with internal and external partners at all levels of the organization.

• Strategic and pragmatic compliance mindset with strong business acumen.

• High ethical standards and sound judgment, and committed to fostering a culture of integrity, transparency, and continuous improvement.

• Excellent leadership, communication, analytical, and problem-solving skills, with the ability to work collaboratively with legal, scientific, and business functions.

• Demonstrated experience leading, developing, and mentoring compliance professionals, or successfully leading through influence in a matrixed organization.

• Experience leveraging data, insights, and compliance metrics to identify trends and prioritize risk mitigation activities.

• Strong presentation, organizational, and project management skills, capable of handling multiple high-priority projects simultaneously.

• Team-oriented approach to work, and ability to lead through influence in a dynamic environment.

• Ability to travel as required (approximately 25%).

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