Overview
The Associate Director, Legal Counsel will be a member of the Global R&D Legal practice area supporting Research Development, Development, and Global Technical Operations and Quality (TOQ). This role primarily supports Development and reports to the Vice President, General Counsel, Research & Development.
This is a hybrid/remote position requiring periodic in-person engagement at Alnylam’s Cambridge, MA, or Maidenhead, UK offices.
Key Responsibilities
Legal Support for Development
* Partner with senior legal leadership to provide strategic advice on clinical programs conducted in over 50 countries, focusing on US, Canada, UK, and EU.
* Interpret laws and regulations in these jurisdictions, advising on compliance risks.
* Serve as in-house expert on EU and UK laws affecting global trials, including in vitro diagnostic regulations (e.g., IVDR).
* Participate as a legal member on program and operational committees, assessing legal risks related to product liability, ethics, privacy, and compliance.
* Escalate safety and legal issues appropriately, review clinical documents, and support regulatory and safety reporting.
* Manage contractual issues related to clinical trials and review informed consent documents.
Overall Legal Support for R&D
* Collaborate with global legal teams to support R&D functions and manage third-party relationships.
* Provide legal guidance on policies, templates, and governance to facilitate global growth.
* Work with IP and Business Development legal teams on related issues.
* Ensure legal compliance and process improvements across R&D activities.
Qualifications
* Juris Doctor degree required.
* At least 6 years of legal experience advising on R&D, either in-house or at a law firm.
* Expertise in EU and UK clinical trial regulations; experience with in vitro diagnostic regulations is a plus.
* Proven experience drafting and negotiating R&D agreements.
* Strong communication, collaboration, and project management skills.
* Ability to prioritize and manage multiple issues in a dynamic environment.
About Alnylam
Alnylam Pharmaceuticals is a leader in RNA interference (RNAi) therapeutics, transforming genetic medicine since 2002. Our culture emphasizes innovation, openness, urgency, excellence, and inclusivity. We are committed to diversity and equal opportunity in our workplace.
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