General Counsel, R&D Legal

General Counsel, R&D Legal at BeOne Medicines

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description

BeOne Medicines is seeking a highly experienced R&D attorney with deep experience to provide comprehensive legal support for the global R&D function. As a key member of both the Legal and R&D leadership teams, you will play a pivotal role in navigating the complex legal landscape associated with research and development in the biotech sector.

This role will be a critical addition to the company, providing legal guidance, regulatory support, and risk management expertise to propel our oncology and inflammation & immunology research and development programs forward. The ideal candidate will possess a deep understanding of biotech and pharmaceutical law, intellectual property, and regulatory compliance, particularly as it pertains to R&D. As the Leader of the R&D Legal function this role will support all facets of R&D including Regulatory, Research, Development, Clinical Operations, Safety and Pharmacology.

Position is a remote role based in the US.

Essential Functions Of The Job

• Provide comprehensive legal support to the global R&D function, ensuring effective risk management and compliance with applicable laws and regulations.
• Partner with R&D leaders to shape and implement strategies that align with the company’s objectives and mission.
• Advise on regulatory matters affecting R&D, including clinical trials, product and companion diagnostics development, and submissions to regulatory authorities (e.g., FDA, EMA, CDE).
• Stay current on developments in laws and regulations affecting the biotech industry and advise internal stakeholders accordingly.
• Negotiate and draft a wide variety of agreements related to R&D, including collaboration agreements, licensing agreements, and clinical trial agreements. Ensure that contracts are compliant with legal standards and aligned with the company’s strategic goals.
• Collaborate closely with other departments to provide integrated legal support and guidance.
• Serve as a key advisor and stakeholder to promote a culture of compliance and ethical conduct in R&D programs.
• Build, lead, and mentor a high-performing legal team, fostering a collaborative and results-oriented environment.
• Identify and evaluate potential legal risks associated with R&D activities and develop strategies to mitigate these risks.
• Prepare and present legal analyses and recommendations to the executive team and Board of Directors.

Qualifications

• 15+ years of relevant legal experience, which includes a focus on pharmaceutical, biotech, or related life science matters/clients, 5+ years of which should be in-house with a biotech/pharma company.
• A U.S. law degree (J.D.) and current “good standing” admission to at least one U.S. state bar.
• An ability to support global working hours.
• Must have demonstrable mastery of human subject research protection laws; Federal Food, Drug and Cosmetic Act and related regulations; US and global privacy laws; US fraud & abuse laws; and other applicable federal and state laws governing the research and development of human therapeutics.
• Must have significant experience involving clinical development programs, data sharing arrangements, clinical supply arrangements, companion diagnostic developments, complex research collaborations and consortia.
• Mandarin is a plus.
• Proven knowledge of biotech law, regulatory requirements, and intellectual property issues in the context of drug development.
• Strong negotiation and communication skills, with the ability to influence cross-functional stakeholders and drive legal initiatives.
• Experience managing a legal team and providing strategic direction.
• Exceptional analytical and problem-solving abilities, with a proactive approach to risk management.
• Ability to approach complex problems with a creative and growth mindset, able to navigate risks by providing mitigation strategies and pragmatic solutions.
• Experience with AI and digital health is helpful though not required, but a willingness to learn is a must.
• Excellent verbal and written communication skills, awareness and ability to engage with others in a global ecosystem, along with a confidence for advising VP-level leadership and swiftly responding to and de-escalating as needed.
• Excellent judgment and superior business partnering skills, and the organizational savvy to effectively collaborate with and influence multidisciplinary global colleagues and external partners.
• Ability to deliver clear, concise and practical advice and mitigation strategies regarding challenging legal issues to legal and non-legal colleagues, including senior management.
• Ability to prioritize and work with agility across multiple projects.
• Aptitude and interest to learn the scientific/technical side of the business.

Supervisory Responsibilities

Manage a global team.

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Key skills/competency

• Biotech Law
• Regulatory Compliance
• Clinical Trials
• Intellectual Property
• Risk Management
• Contract Negotiation
• Legal Strategy
• Leadership
• FDA Regulations
• Global Privacy Laws