Senior R&D Counsel, Europe and New Markets
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pBeOne 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. /p pBeOne Medicines is seeking an experienced Senior RD counsel to provide strategic and practical legal support for RD activities across Europe and selected New Markets. This role will serve as a trusted partner to regional and global RD stakeholders and will work closely with colleagues across Legal Compliance to support research, development, regulatory, clinical, safety, medical and related activities. /p pThe Senior RD Counsel will advise on legal and regulatory issues arising throughout the product-development lifecycle, with particular emphasis on clinical research, data use and privacy, vendor and site arrangements, and implementation of global programs in diverse local legal environments. The ideal candidate will combine strong legal judgment with a pragmatic, solutions-oriented approach and the ability to work effectively across cultures, jurisdictions and time zones. /p pThe position is based in Switzerland, Germany or Italy. /p h3Essential Functions Of The Job /h3 ul liProvide timely, business-focused legal advice to RD stakeholders supporting activities in Europe and selected New Markets, in alignment with global RD Legal strategy and company priorities. /li liAdvise 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. /li liPartner with Regulatory, Clinical Development, Global Clinical Operations, Safety, Medical and other functions to identify legal risks early and develop proportionate mitigation strategies. /li liDraft, review and negotiate a broad range of RD agreements, including clinical trial, central-vendor, clinical-supply, technology and services agreements. /li liAdvise on regional implementation of global RD policies, standards, templates and processes, while identifying where local-law adaptations or escalation are required. /li liMonitor legal and regulatory developments across the supported markets, assess business impact and communicate clear, actionable guidance to relevant stakeholders. /li liCoordinate with Compliance, Privacy, Intellectual Property and other legal functions to provide integrated advice and consistent risk management. /li liSupport inspections, audits, investigations, disputes and remediation activities involving RD matters, as needed. /li liDevelop and deliver training and practical guidance for RD colleagues on relevant legal requirements and contracting practices. /li liContribute to the continued development of the global RD Legal function, including knowledge management, process improvement and cross-regional collaboration. /li /ul h3Qualifications /h3 ul liLaw degree or equivalent professional legal qualification, with current authorization or good standing to practice in at least one relevant jurisdiction. /li liTypically 7 or more years of relevant legal experience in the pharmaceutical, biotechnology, medical-device or broader life-sciences sector, including meaningful in-house or closely comparable client-facing experience. Equivalent combinations of experience may be considered. /li liSubstantial experience advising on clinical development in Europe. Experience supporting one or more markets in the Middle East, Africa, or other emerging or growth markets is strongly preferred. /li liStrong working knowledge of legal and regulatory frameworks relevant to RD, including clinical trial regulation, research ethics, pharmacovigilance, data protection and privacy, and laws governing interactions with healthcare professionals and institutions. /li liDemonstrated experience with complex RD contracting, including clinical, research, data, sample, technology, vendor and collaboration arrangements. /li liAbility to analyze unfamiliar local-law issues, engage qualified local counsel appropriately, and translate legal advice into practical options for global and regional stakeholders. /li liExcellent written and verbal communication skills in English. Proficiency in an additional language relevant to the supported markets is an advantage. /li liStrong negotiation, influencing and stakeholder-management skills, with the confidence to advise senior leaders and the judgment to elevate significant issues promptly. /li liAbility to prioritize competing demands, work with agility across multiple jurisdictions and projects, and collaborate effectively in a matrixed global organization. /li liCuriosity and aptitude for learning the scientific, technical and operational aspects of drug research and development. /li liExperience with