Senior R&D Counsel, Europe and New Markets (Director)

About the role

BeOne Medicines is looking for an experienced Senior R&D Counsel to give strategic and practical legal support for R&D activities across Europe and selected New Markets. The role works closely with colleagues across Legal & Compliance on research, development, regulatory, clinical, safety and medical activities, and advises on legal and regulatory issues throughout the product-development lifecycle, especially clinical research, data use and privacy, vendor and site arrangements and global programmes in different local legal environments. It is based in Switzerland, Germany or Italy.

Key responsibilities

• Provide timely, business-focused legal advice to R&D stakeholders in line with global R&D legal strategy.
• Advise on the design, start-up and conduct of clinical trials and other human-subject research, including informed consent, ethics committee requirements, patient recruitment, decentralized or technology-enabled trial elements and interactions with investigators, institutions and vendors.
• Partner with Regulatory, Clinical Development, Global Clinical Operations, Safety and Medical to identify legal risks early and develop mitigation strategies.
• Draft, review and negotiate clinical trial, central-vendor, clinical-supply, technology and services agreements.
• Advise on regional implementation of global R&D policies, standards, templates and processes, and flag where local-law adaptation or escalation is needed.
• Monitor legal and regulatory developments across supported markets and communicate clear, actionable guidance.
• Coordinate with Compliance, Privacy, Intellectual Property and other legal functions, and support inspections, audits, investigations, disputes and remediation.
• Deliver training and practical guidance on legal requirements and contracting, and contribute to the global R&D Legal function.

Required profile

• Law degree or equivalent professional qualification, with current authorization or good standing to practice in at least one relevant jurisdiction.
• Typically 7+ years of legal experience in the pharmaceutical, biotechnology, medical-device or life-sciences sector, including in-house or client-facing work; equivalent combinations may be considered.
• Substantial experience advising on clinical development in Europe; experience in the Middle East, Africa or other emerging markets is strongly preferred.
• Strong knowledge of clinical trial regulation, research ethics, pharmacovigilance, data protection and privacy, and laws governing interactions with healthcare professionals and institutions.
• Experience with complex R&D contracting (clinical, research, data, sample, technology, vendor and collaboration arrangements).
• Excellent English; proficiency in another language relevant to the markets is an advantage.

Required skills

• Analyzing unfamiliar local-law issues, engaging local counsel and translating advice into practical options.
• Negotiation, influencing and stakeholder-management, with the confidence to advise senior leaders.
• Prioritizing competing demands and collaborating in a matrixed global organization.
• Curiosity about the science and operations of drug research and development.