Sobre esta vaga de Corporate Compliance Director (Oncology) na Natera
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.
- Solutions-oriented mindset with the ability to navigate regulatory ambiguity and develop thoughtful, risk-based recommendations rather than relying solely on rigid interpretations.
- Ability to build credibility and trusted relationships with Sales, Marketing, Medical and executive stakeholders.
- Excellent verbal, written and presentation skills, including the ability to communicate complex compliance concepts clearly to non-compliance audiences.
- Strong judgment, discretion and ability to manage sensitive or confidential matters.
- Excellent research, analytical and problem-solving capabilities.
- Demonstrated ability to independently manage multiple priorities and complex projects.
- Strong attention to detail while maintaining a broader strategic perspective.
Work Environment
- Duties are primarily performed in a remote home-office environment.
- Ability to communicate effectively through virtual meetings, email and telephone.
- Occasional evening or weekend work may be required based on business needs.
- Travel: approximately 10–20%.
OUR OPPORTUNITY
Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. 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.
The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
WHAT WE OFFER
Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!
For more information, visit www.natera.com.
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
If you are based in California, we encourage you to read this important information for California residents.
Link: https://www.natera.com/notice-of-data-collection-california-residents/
Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.
For more information:
- BBB announcement on job scams
- FBI Cyber Crime resource page
