Provide comprehensive legal support to the global R&D function.
Partner with R&D leaders to implement strategies aligning with company objectives.
Advise on regulatory matters affecting R&D, including clinical trials and submissions to regulatory authorities.
Negotiate and draft a variety of R&D agreements, ensuring compliance with legal standards.
Collaborate with other departments to offer integrated legal support.
Build, lead, and mentor a high-performing legal team.

15+ years of relevant legal experience, focusing on pharmaceutical, biotech, or related life science matters/clients, 5+ years in-house with a biotech/pharma company.
A U.S. law degree (J.D.) and current admission to at least one U.S. state bar.
Ability to support global working hours.
Mastery of human subject research protection laws; Federal Food, Drug and Cosmetic Act; US and global privacy laws; US fraud & abuse laws; and other applicable laws governing human therapeutics.
Significant experience with clinical development programs, data sharing arrangements, clinical supply arrangements, companion diagnostic developments, complex research collaborations and consortia.
Proven knowledge of biotech law, regulatory requirements, and intellectual property issues in drug development.
Experience managing a legal team and providing strategic direction.
Exceptional analytical and problem-solving abilities with a proactive risk management approach.
Ability to deliver clear, concise advice on challenging legal issues to both legal and non-legal colleagues.

Associate General Counsel – Head of R&D Legal

Key skills