- Serve as 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 as well as 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 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 in supporting 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 Vir's transactional group by providing regulatory and compliance guidance with respect to 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 Vir's external advisory boards.
- Support Vir's 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, Vir policies and procedures and the current and future needs of the organization.
- Exhibit superior legal skills together with a proficiency for critical thinking and problem solving in a multi-functional environment.
- 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 and understanding of the requirements for effective 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.
- Proven ability to appropriately prioritize issues and allocate resources, to demonstrate a history of successfully resolving challenging legal issues and to effectively deliver sound and clear legal advice in a business setting.
- 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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Sr. Director, Healthcare Law - San Francisco, CA, United States - Vir Biotechnology, Inc.
Description
THE OPPORTUNITY
Vir is seeking 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. This individual will advise on privacy matters on behalf of Vir and provide strategic advice on healthcare compliance issues to the company.
This role is located in San Francisco at our corporate office and there is a requirement to be onsite at least three days per week.
WHAT YOU'LL DO
WHO YOU ARE AND WHAT YOU BRING
#LI _AA1
#LI-Onsite
WHO WE ARE AND WHAT WE OFFER
The expected salary range for this position is $225,500.00 to $329, Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
Vir's compensation and benefits are aligned with the current market and commensurate with the person's experience and qualifications. All full-time employees receive a package that includes: compensation, bonus and equity as well as many other Vir benefits and perks such as: health, dental, vision, life and disability insurance benefits, non-accrual paid time off, company shut down for holidays, commuter benefits, child care reimbursement, education reimbursement, 401K match and lunch for all onsite employees
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Sr. Director, Healthcare Law professionals in San Francisco
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Stephen Foster
Private Wealth Professional