Director, R&D Counsel, Europe – New Markets

Job not on LinkedIn

🔥 59 minutes ago

🌐 Switzerland, Germany, +1 more countries – Remote

🇨🇭 Switzerland – Remote 🇩🇪 Germany – Remote 🇮🇹 Italy – Remote

💵 CHF181.4k - CHF226.8k / year

⏰ Full Time

🔴 Lead

⚖️ Legal Counsel / General Counsel

👻 Ghost score 0%

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• 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

🎯 Requirements

• 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