Senior Director, Healthcare Law

Vir Biotechnology is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies.

We believe the success of our colleagues drives the success of our mission. We are committed to creating a company where everyone feels supported and encouraged to give their best.

THE OPPORTUNITY

Vir Biotechnology is looking for a dynamic and experienced Healthcare Law Attorney with compliance and privacy experience to join our Legal team as we further our mission of addressing unmet need in infectious diseases and other serious conditions. Reporting to our EVP, General Counsel & Corporate Secretary, you will provide and oversee the development, execution, analysis, interpretation and communication of healthcare law aspects to Vir Biotechnology. You will advise on privacy matters and provide strategic advice on healthcare compliance issues to the company.

This role is located in our San Francisco headquarters with an expectation of 4 days per week in office.

WHAT YOU'LL DO

• Be the lead counsel for healthcare law issues related to our product candidates, including review of scientific, clinical, and medical publications, and participating in cross-functional committees charged with setting/implementing clinical and commercial development.
• Support our clinical operations by providing review of Informed Consent Forms (ICFs), management of adverse events/patient injury issues, and handling of site-specific issues/study promotions.
• Advise internal teams on clinical, commercial, privacy, and governmental legal matters, including support for Freedom of Information Act (FOIA) requests.
• Provide guidance on healthcare laws and regulations affecting biopharmaceutical products and operations-this includes compliance, fraud and abuse, privacy, pharmacovigilance, product liability, advertising/labeling and other matters relevant to investigational and commercial therapeutic products.
• Lead Vir Legal function on all data privacy matters specifically related to clinical operations
• Support our internal teams on healthcare compliance including the Food, Drug, and Cosmetic Act (FDCA), FDA guidance, U.S. PhRMA Code, Sunshine Act, HIPAA, Stark Law, Anti-Kickback Statute, GDPR, and similar regulations.
• Support our transactional group by providing regulatory and compliance guidance for clinical trial agreements, consulting agreements, speaker agreements, advisory board agreements, and certain vendor services agreements.
• Provide compliance guidance related to contracting with HCPs, including conducting FMV analysis and transparency reporting with respect to our external advisory boards.

WHO YOU ARE AND WHAT YOU BRING

• Bachelor's degree and J.D. from a nationally accredited law school; and admitted and in good standing in a U.S. Jurisdiction (preferably California).
• 15+ years as healthcare law counsel at a biotechnology or pharmaceutical company and/or a law firm supporting pharmaceutical/biotech clients, preferably with product launch experience
• Command of relevant laws, regulations, guidance and industry codes governing healthcare products, regulatory aspects of healthcare products, healthcare fraud and abuse, global clinical trials, pharmacovigilance, advertising and labeling, product liability, pricing and reimbursement, antitrust, and data privacy
• Experienced in building, advising, and implementing compliance programs, following guidelines such as OIG and Federal Sentencing Guidelines.

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WHO WE ARE AND WHAT WE OFFER

The expected salary range for this position is $235,500 - $329,500 per year. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.

Applicants must currently be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

All employment decisions at Vir Biotechnology are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications. Employment decisions are made without regard to any legally protected characteristics.

This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs. Vir Biotechnology also strongly commits to providing employees with a work environment free of unlawful conduct or harassment.

Vir Biotechnology Human Resources leads recruitment and employment for Vir Biotechnology. Unsolicited resumes sent to the company from recruiters do not constitute any type of relationship between the recruiter and Vir Biotechnology and do not obligate us to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.

For hires based in the United States, Vir Biotechnology, participates in E-Verify.

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