Senior Counsel, Clinical/R&D Legal

Primary Responsibilities

• Lead the drafting, negotiation, and management of a broad range of clinical development, research, manufacturing, and vendor agreements, including clinical trial agreements (CTAs), investigator and site agreements, MSAs, SOWs, CRO agreements, laboratory services agreements, CMO agreements, and other strategic vendor arrangements.
• Serve as a trusted legal partner to clinical, research, manufacturing, regulatory, pharmacovigilance, quality, data management, and project management teams by providing practical, risk-based legal advice on day-to-day operational matters.
• Support regulatory affairs team with legal issues arising from their interaction and coordination with regulatory authorities, including the FDA, EMA, and other global health authorities.
• Advise on legal and compliance issues related to clinical development, medical affairs, regulatory affairs, healthcare compliance, interactions with healthcare professionals and patient advocacy organizations, privacy, and pre-commercial activities.
• Collaborate with Privacy, Information Security, Clinical Operations, and HR to address cross-functional compliance issues, such those under HIPAA and GDPR.
• Monitor relevant legal and regulatory developments affecting the biotechnology and pharmaceutical industries and provide timely guidance to stakeholders on emerging risks and opportunities.

Growth and Expansion Opportunities

• In addition to the role’s core Clinical/R&D responsibilities, this position is designed to provide exposure to broader legal and business issues over time, including:
• Strategic licensing, business development, supply, services, consulting, confidentiality, and other commercial agreements.
• Contract lifecycle management initiatives and AI-enabled legal technologies, including stakeholder training, governance, policy development, implementation, and ongoing optimization.
• Provide broad-based cross-functional legal support across the organization consistent with the needs of a lean, high-performing legal team, including employment matters (in coordination with HR and outside counsel), litigation management, intellectual property coordination, public affairs and communications review, vendor and technology contracting, policy development, and training.
• Opportunities to help build scalable legal processes, templates, playbooks, and practical ways of working.