Summary

Location: Cambridge, MA US

The Novartis Legal team is seeking a Vice President, Head of R&D Legal for the Americas, responsible for leading the legal support for the Biomedical Research organization in the U.S. and all clinical development and study operation activities across the Americas, and managing a team of legal and administrative personnel.

About the Role

Key Responsibilities:

• Lead the development and implementation of legal strategies and counsel in support of the Biomedical Research (BR) organization, with a focus on U.S.-based activities in particular. Key accountabilities include:
  • Legal leadership responsibility for regulatory, transactional and business legal counseling in support of the BR organization, with primary responsibility for the legal work arising out of the Cambridge, San Diego and Emeryville sites. Areas of legal support span across pre-clinical research and early- stage clinical development and include academic research collaborations, Global Health projects, data use and sharing, trade secret protection, advising on new modalities and technologies including AI/machine learning platforms, counseling on issues involving scientific integrity, and advising on CRO and other research outsourcing arrangements.
  • Advising senior leaders in BR on priority programs and strategies by providing pragmatic counselling and proactively identifying opportunities and creative solutions to advance BR business priorities.
  • Collaborating with other legal teams that support BR, including R&D IP and Legal Transactions, to ensure the delivery of seamless legal support to BR holistically. Partner with R&D IP to ensure the ownership, control and protection of inventions.
• Legal leadership responsibility for all legal and regulatory counsel and contracting support for development activities in the region. Key accountabilities of the R&D Legal, Americas team include:

• Legal advising to support the conduct of clinical trials in the region, including informed consent, patient recruitment and reimbursement, site selection, site and clinical vendor contracting and payments, IRB negotiations, data integrity, and related health authority regulatory issues. Adapt global contracting templates and playbooks as needed to reflect local requirements.
• Counselling on regulatory issues involving development filing strategies, regulatory exclusivity, device requirements, trial and protocol transparency reporting, the handling and reporting of drug safety issues, fair market value requirements, Good Clinical Practices, orphan drug qualifications, pediatric obligations, and other development-related matters specific to the region. Also, partner with Regulatory Affairs and local country attorneys to advise on regulatory policy developments in the region and proactively develop policy shaping strategies to support Novartis research and development objectives.
• Supporting 3rd party relationships on behalf of the Global Clinical functions as they relate to study activities in the region, including advising on and assisting in the negotiation of clinical procurement agreements and outsourced clinical trials. Develop legal strategies to streamline and simplify the overall contracting process.
• Provide pragmatic counselling to leaders in the Development organization and proactively identify business opportunities and creative solutions that reflect a solid understanding of needs across the Novartis RDC continuum.

• At least 15 years' post bar admission experience ideally gained within an international life sciences and/or pharmaceutical environment or alternatively, with a top-tier law firm representing pharmaceutical clients.
• Experience of managing a team of attorneys and successfully supporting their professional development.
• At least 10 years of experience advising senior leaders on all aspects of research and drug development programs in one or more jurisdictions in the region, including the support of pre-clinical research, research collaborations, molecule and platform licensing, and the conduct of early and late-stage clinical trials and related health authority regulatory matters.
• Legal experience supporting outsourced trials through Contract Research Organizations, and complex contracting negotiations with clinical vendors.
• Demonstrated success developing and driving cross-functional organizational process improvements to create business efficiency and/or advance corporate priorities.
• Experience advising and training on regulatory, legal compliance and risk management issues related to research and drug development.
• Ability to analyze complex legal issues.
• A connector with an enterprise mindset and organizational savvy to deliver results.
• A pragmatic problem solver, driven not only to identify issues but to actively seek innovative and practical solutions.
• Strong verbal & written communication skills, together with a high ability to influence and negotiate.
• Sound experience in handling a high volume of activity involving multiple, often complex projects simultaneously.
• Professional & culturally sensitive work ethic.
• Financial and business acumen.
• A science background is preferred but not required.