Executive Director, R&D Legal, Americas

Band

Level 7

 

Job Description Summary

#LI-Hybrid
Location: Cambridge, MA

This position will be located at the Cambridge, MA site and will not have the ability to be located remotely. This position will require about 10-15% travel as defined by the business (domestic and/ or international).

The Executive Director, R&D Legal for the Americas will be responsible for: (1) providing legal support for U.S.-based activities of the Biomedical Research (BR) organization, (2) providing legal counsel and contract support of clinical development and study operation activities in the Americas, and (3) providing legal counsel and transactional support of partnered collaborations.

 

Job Description

Key responsibilities:

• Counsel on a broad range issues in support of the Biomedical Research (BR) organization, with primary responsibility for the legal work arising out of the Cambridge site. Areas of legal support include early and translational research, academic collaborations, partner/alliance management, consortia membership, public and private partnerships, animal welfare, trade compliance, data use and sharing, trade secret protection, contamination risks, biospecimen compliance, competitor evaluations, counseling on issues involving scientific and data integrity, advising on new modalities and technologies, including AI/machine learning and digital tools, and managing third party subpoenas and claims.

• Counsel on a broad range of issues in support of clinical development and study operation activities in the Americas. Areas of legal support include research privacy and informed consent, site selection, patient recruitment and retention, institutional review board negotiations and approval, decentralized trials, study fees and fair market value, data use and sharing, and scientific and data integrity.

• Advise on GxP matters from a U.S. legal perspective in support of research and development activities, namely good laboratory and clinical practices. Responsibilities include counseling on deviations, internal monitoring and audit activities, corrective action plans, reporting requirements, and inspection readiness. 

• Adapt global contracting templates and playbooks as needed to reflect local requirements. Deliver contracting and negotiation support for research and development activities in collaboration with other legal and contracting groups.

• 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, and legal integration activities involving the transition of acquired development programs.

• Provide alliance management legal advising and contracting support for research and development partnered collaborations. Collaborate and coordinate with various legal and business stakeholders on legal issues relating to research and development collaborations, transactions and integration of acquired companies and assets. 

• Legal review and advice on Novartis policies, SOPs and overall legal governance to ensure compliance with legal and regulatory requirements.

• 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:

• Law degree and bar admission

• At least 10-15 years’ post bar admission experience in the life sciences industry (preferably biotechnology or pharmaceutical) or a top-tier law firm representing pharmaceutical clients and advising senior leaders on legal issues, business risks and disputes.

• Significant knowledge of drug research & development strategies and activities, along with significant experience providing legal counsel on issues involving drug research & development, including: lab safety, GxP compliance, animal welfare, trade compliance, research privacy, data use and sharing, biospecimen compliance, scientific and data integrity, site selection, patient recruitment and retention, study fees and fair market value, and research collaborations. 

• Significant experience providing legal counsel and contracting support of research and development transactions and/or business development deals. 

• Experience providing alliance management legal advice and transactional support in the biotechnology or pharmaceutical industry, including: machine learning/artificial intelligence, academic research collaborations, public and private partnerships, consortiums