Executive Director, R&D Legal and FDA Regulatory Legal Lead

Job Description Summary

Location: East Hanover, NJ US

The Novartis Legal team is seeking an Executive Director for its R&D Legal Team responsible for providing U.S. legal and FDA regulatory counsel in support of drug development, patient safety, and quality matters. This individual will support the Global Regulatory Affairs function on a broad range of matters spanning drug development, approval strategies, data integrity, and health authority regulatory requirements and interactions. They also will provide legal counsel and contract support for the conduct of Novartis clinical trials in the Americas.

 

Job Description

Key Responsibilities:

• Counsel on a broad range of issues in support of Novartis clinical trials, including in the areas of informed consent, site selection, patient recruitment and reimbursement, institutional review board negotiations and approval, study fees and fair market value, data use, and scientific and data integrity.
• Legal advisor to Global Regulatory Affairs and Development program leads on FDA strategies and matters involving drug development programs and drug/medical device regulations, including pre-clinical regulatory requirements, program filing strategies, investigational new drug applications, FDA approval pathways, regulatory exclusivity, pediatric and orphan drug requirements, decentralized clinical trials, FDA advisory committee hearings, clinical trial reporting, medical device requirements, and FDA investigations and enforcement actions related to the conduct of clinical trials.
• Provide holistic strategic legal advice to help Novartis navigate complex drug development issues within the context of a global regulatory environment. This involves providing legal counsel and support to senior leaders in Global Regulatory Affairs on a broad range of development and drug safety matters beyond those just before the FDA. Serve as a global legal regulatory advisor on rapid response teams and other priority matters involving Novartis development programs.   
• Advise on GxP matters from a U.S. legal perspective in support of research and development activities, namely good clinical and laboratory practices. Responsibilities include counseling on deviations, internal monitoring and audit activities, corrective action plans, FDA reporting requirements, and GCP and GLP-related FDA inspections, investigations and enforcement actions.
• Provide legal regulatory advice on U.S. pharmacovigilance compliance and drug safety matters, including FDA reporting requirements, internal monitoring and auditing, corrective action plans, dear healthcare provider letters, and FDA inspections, investigations and enforcement actions involving pharmacovigilance.
• Monitor drug development industry and policy trends and proactively advise on strategies to shape the landscape and support the success of Novartis drug development programs in the context of an evolving and competitive external environment.  Provide legal-regulatory advice on proposed legislation, regulations and FDA guidance to inform advocacy efforts.
• Advice on business development deals from a technical R&D legal perspective to support due diligence of pre-clinical and clinical stage external assets, deal terms, FDA regulatory strategies, and legal integration activities involving the transition of acquired development programs.
• Legal review and advice on Novartis policies, SOPs and trainings to ensure compliance with FDA regulatory requirements.
• Provide legal advice and contracting support for the conduct of clinical trials in the Americas with a focus on priority programs, trial acceleration, and access. Adapt global contracting templates and playbooks as needed to reflect local requirements.
• Coordinate and collaborate with various other internal stakeholders as necessary regarding global legal regulatory matters and regional development issues. Such stakeholders include R&D IP, International Legal, Regulatory Affairs, Procurement, Tax, Ethics, Risk and Compliance, and others.
• Anticipate and proactively advise on strategies to simplify or streamline the work of business teams and/or create impact to advance business priorities.
• Actively support the R&D Legal team and broader Security and Legal organization by mentoring, coaching, sharing knowledge and best practices, and contributing to the culture and community.

Essential Requirements:

Education: Law degree and bar admission required.

Fluency in English essential

Experience / Skills/ Competencies:        

• At least 15 years’ post bar admission experience in the life sciences industry (preferably biotechnology or pharmaceutical), with the U.S. Food and Drug Administration, or a top-tier law firm representing pharmaceu