Executive Director, R&D Legal, Americas

Job Description Summary

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, divestments, research services agreements, and licensing of compounds, cell lines, and platforms.

• Ability to analyze complex legal issues.

• 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. A connector with an enterprise mindset and organizational savvy to deliver results.

• Sound experience in handling a high volume of activity involving multiple, often complex projects simultaneously.

• Professional & culturally sensitive work ethic.

• Ability to support global working hours.

• Financial and business acumen.

Desirable Requirements:

• A science background is preferred but not required.

Novartis Compensation Summary:

The salary for this position is expected to range between $236,600.00 and $439,400.00 per year.

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

Skills Desired