Director, R&D Counsel, Europe – New Markets

• Provide strategic and practical legal support for R&D activities across Europe and selected New Markets
• Serve as a trusted partner to regional and global R&D stakeholders
• Advise on legal and regulatory issues throughout the product-development lifecycle
• Advise on the design, start-up and conduct of clinical trials and human-subject research
• Partner with Regulatory, Clinical Development, Global Clinical Operations, Safety, Medical and other functions to identify legal risks 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
• Monitor legal and regulatory developments across supported markets and communicate actionable guidance
• Coordinate with Compliance, Privacy, Intellectual Property and other legal functions
• Support inspections, audits, investigations, disputes and remediation activities involving R&D matters
• Develop and deliver training and practical guidance for R&D colleagues
• Contribute to global R&D Legal knowledge management, process improvement and cross-regional collaboration

• Law degree or equivalent professional legal qualification, with current authorization or good standing to practice in at least one relevant jurisdiction
• Typically 7 or more years of relevant legal experience in the pharmaceutical, biotechnology, medical-device or broader life-sciences sector
• Meaningful in-house or closely comparable client-facing experience
• Substantial experience advising on clinical development in Europe
• Strong working knowledge of clinical trial regulation, research ethics, pharmacovigilance, data protection and privacy, and laws governing interactions with healthcare professionals and institutions
• Demonstrated experience with complex R&D contracting, including clinical, research, data, sample, technology, vendor and collaboration arrangements
• Ability to analyze unfamiliar local-law issues and engage qualified local counsel appropriately
• Excellent written and verbal communication skills in English
• Proficiency in an additional language relevant to supported markets is an advantage
• Strong negotiation, influencing and stakeholder-management skills
• Ability to prioritize competing demands and collaborate across multiple jurisdictions and projects in a matrixed global organization
• Curiosity and aptitude for learning scientific, technical and operational aspects of drug research and development
• Experience with digital health, artificial intelligence, decentralized clinical trials or advanced data analytics is helpful but not required