Natera
Corporate Compliance Director (Oncology)
US Remote · Director
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About the role
- The ideal candidate combines strong healthcare and laboratory compliance expertise with experience supporting pharmaceutical clinical trials, preferably within oncology.
- 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.
Responsibilities
- 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.
- Support policy development and maintenance, compliance assessments, investigations, audits and other Corporate Compliance initiatives as needed.
- Collaborate with Compliance and Legal leadership on special projects and emerging compliance priorities.
Requirements
- Strong critical-thinking skills and demonstrated ability to exercise sound judgment in complex or ambiguous situations.
- 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 with clinical laboratory compliance and applicable OIG guidance.
- 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.
- Preferred
- Healthcare compliance experience within the pharmaceutical, biotechnology, clinical laboratory or diagnostics industry.
- Experience supporting commercial and medical activities involving healthcare professionals, including advisory boards, speaker programs and consulting engagements.
Compensation
- The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location.
Benefits
- 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.
- Advise on healthcare professional interactions and engagements, including advisory boards, speaker programs, consulting arrangements and other activities involving physicians and potential referral sources.
- 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.
- Develop and deliver effective compliance education and training tailored to business needs and emerging risk areas.
- Monitor evolving federal and state healthcare laws, regulatory guidance and industry practices and help translate changes into practical guidance for the business.
- Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.
This listing is sourced directly from Natera's careers page and normalized into a canonical job model.