Corporate Compliance Director (Oncology)

About this role

Director, Corporate Compliance

Position Summary

The Director, Corporate Compliance will serve as a strategic compliance partner to key business functions across Natera, with particular focus on our rapidly growing Oncology business. Reporting to the Sr. Director of Corporate Compliance, this individual will provide practical, solutions-oriented compliance guidance to business leaders while helping the organization identify, assess, and proactively manage healthcare compliance risk.

This role will partner closely with Oncology Sales, Marketing, Medical and other cross-functional stakeholders and will provide compliance guidance related to commercial activities, clinical trials, pharmaceutical partnerships, companion diagnostics, healthcare professional engagements, and other evolving business initiatives.

The ideal candidate combines strong healthcare and laboratory compliance expertise with experience supporting pharmaceutical clinical trials, preferably within oncology. Success in this role requires someone who can navigate complex or ambiguous situations, apply sound judgment beyond a purely "black-and-white" interpretation of regulations, and establish appropriate guardrails that allow the business to achieve its objectives compliantly.

Primary Responsibilities

• Serve as a trusted compliance advisor and strategic business partner to Oncology leadership and cross-functional teams, including Sales, Marketing, Medical/MSL and other key stakeholders.

• Provide practical, risk-based guidance on proposed business initiatives, helping stakeholders understand what is permissible and establishing appropriate compliance guardrails.

• Provide compliance oversight and guidance related to pharmaceutical collaborations, clinical trials, companion diagnostics and other activities supporting Natera's growing Oncology business.

• Advise on healthcare professional interactions and engagements, including advisory boards, speaker programs, consulting arrangements and other activities involving physicians and potential referral sources.

• Identify and proactively assess emerging compliance risks associated with new business models, programs, partnerships and commercial activities.

• Develop, implement and monitor key healthcare and laboratory compliance programs and risk areas in accordance with applicable laws, regulations and OIG guidance for clinical laboratory compliance programs.

• Partner cross-functionally to develop practical solutions that balance business objectives with regulatory and compliance requirements.

• Support the development and execution of strategic Compliance initiatives aligned with the short- and long-term objectives of Natera's business units.

• Conduct compliance risk assessments, monitoring and testing activities and recommend appropriate controls or remediation strategies when gaps are identified.

• Develop and deliver effective compliance education and training tailored to business needs and emerging risk areas.

• Analyze compliance trends, findings and risk indicators and communicate actionable insights and recommendations to Compliance leadership and business stakeholders.

• Support policy development and maintenance, compliance assessments, investigations, audits and other Corporate Compliance initiatives as needed.

• Monitor evolving federal and state healthcare laws, regulatory guidance and industry practices and help translate changes into practical guidance for the business.

• Collaborate with Compliance and Legal leadership on special projects and emerging compliance priorities.

Qualifications

Required

• Bachelor's degree in healthcare, life sciences, biology, pharmaceuticals, business, legal studies or another related field.

• 8+ years of relevant professional experience, including significant experience in healthcare compliance.

• Strong working knowledge of U.S. healthcare laws and regulations applicable to interactions with healthcare professionals and referral sources, including the Anti-Kickback Statute, Stark Law, Civil Monetary Penalties Law and exclusion authorities.

• Demonstrated experience advising business stakeholders on complex healthcare compliance matters and translating regulatory requirements into practical business guidance.

• Experience identifying, assessing and mitigating healthcare compliance risks and developing appropriate controls and recommendations.

• Strong executive presence and communication skills with the ability to effectively influence and advise stakeholders across Sales, Marketing, Medical, Legal and senior leadership.

• Strong critical-thinking skills and demonstrated ability to exercise sound judgment in complex or ambiguous situations.

Preferred

• Healthcare compliance experience within the pharmaceutical, biotechnology, clinical laboratory or diagnostics industry .

• Experience supporting pharmaceutical-sponsored clinical trials or pharmaceutical collaborations , ideally within oncology .

• Knowledge of compliance considerations related to oncology, companion diagnostics and/or precision medicine .

• Experience supporting commercial and medical activities involving healthcare professionals, including advisory boards, speaker programs and consulting engagements.

• Experience with clinical laboratory compliance and applicable OIG guidance.

• Certified in Healthcare Compliance (CHC) through HCCA/SCCE or equivalent healthcare compliance certification.

• Master's degree in healthcare, business or a related discipline; JD also considered.

• International healthcare compliance experience.

• Experience evaluating compliance considerations associated with emerging technologies, including AI, within healthcare or clinical environments.

Knowledge, Skills & Abilities

• Ability to operate effectively in a fast-paced, dynamic and evolving healthcare environment.

• Strong business acumen with the ability to understand commercial objectives while maintaining appropriate compliance standards.

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