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 infectious disease programs for chronic hepatitis delta and chronic hepatitis B infections 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 complement our growing Legal Department as we further our mission of addressing unmet need in infectious diseases and other serious conditions, including viral-associated diseases. Reporting to our EVP, General Counsel & Corporate Secretary, this attorney 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 all external communications, participation in cross-functional committees charged with setting/implementing clinical and commercial development and reviewing scientific, clinical, and medical publications.
• Provide advice on legal business matters pertaining to clinical and commercial law as well as on privacy and governmental matters, including FOIA requests.
• Provide current and consistent legal advice related to laws, regulations and industry trends affecting Vir Bio and the biopharmaceutical sector, including, for example, healthcare laws, trade compliance guidance documents and regulations, healthcare regulatory issues, healthcare fraud and abuse, pharmacovigilance, advertising and labeling, product liability, pricing and reimbursement, antitrust, privacy, and other matters relevant to investigational and commercial therapeutic products.
• Work with the General Counsel to support our internal teams by providing critical legal advice and guidance related to healthcare compliance including those related to, e.g., FDCA and related FDA Guidance documents, U.S. PhRMA Code, the Sunshine Act, HIPAA, Stark Law, Anti-Kickback Statute, False Claims Act, Conflicts of Interest, GDPR and similar requirements globally.
• Support our transactional group by providing regulatory and compliance guidance for clinical trial agreements, consulting agreements, speaker agreements, purchase and distribution agreements, supply agreements, advisory board agreements, certain vendor services agreements, and other related agreements.
• Provide compliance guidance related to contracting with HCPs, including conducting FMV analysis and transparency reporting with respect to our external advisory boards.
• 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.
• Understand the strategic and tactical objectives of the business and develop creative and thoughtful solutions considering the current legal and regulatory landscape, our policies and procedures and the current and future needs of the organization.
• Manage the drafting, review and negotiation of clinical related contracts and agreements.
• Work with the Clinical Operations team, Legal team and external partners to ensure clinical agreements comply with business best practices and relevant country regulations.
• Draft and negotiate other commercial and complex transactions as assigned.

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.
• Command of relevant laws, regulations, guidance and industry codes governing healthcare products, regulatory aspects of healthcare products, healthcare fraud and abuse, pharmacovigilance, GMP, advertising and labeling, product liability, pricing and reimbursement, antitrust, privacy, and other matters relevant to the development and the commercialization of biotechnology and pharmaceutical products.
• Experience with and/or understanding of compliance issues confronting the pharmaceutical, biotechnology, and/or healthcare industry and knowledge of the requirements for compliance programs as set forth in OIG Guidance and the Federal Sentencing Guidelines.
• Experience drafting, reviewing and implementing healthcare law agreements and other related documents.
  • One or more of the following experiences is preferred:
    • General litigation and artificial intelligence
    • New product launches
    • Global clinical trials and data privacy experience

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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.