Associate Legal Director, Research and Development

Alnylam Pharmaceuticals; Maidenhead; Hybrid; GBP 80,000 - 120,000; Full time

Job summary

An established industry player is seeking an Associate Legal Director to provide strategic legal guidance in Research and Development. This pivotal role involves advising on global clinical programs, navigating complex EU and UK regulations, and collaborating with various teams to ensure compliance and mitigate risks. The ideal candidate will possess a Juris Doctor degree and have extensive experience in clinical trial laws and agreements. Join a forward-thinking organization that values innovation and inclusivity, and make a significant impact in the field of RNA interference therapeutics.

Qualifications

• 6+ years of legal experience in R&D, focusing on clinical and regulatory aspects.
• Expertise in EU and UK clinical trial laws; IVDR experience is a plus.

Responsibilities

• Provide legal advice on global clinical programs and assess legal risks.
• Collaborate with global legal teams to support R&D functions.

Skills

Legal Advice

Regulatory Compliance

Contract Negotiation

Clinical Trial Regulations

Communication Skills

Education

Juris Doctor Degree

Job description

Associate Legal Director, Research and Development

Join to apply for the Associate Legal Director, Research and Development role at Alnylam Pharmaceuticals.

Overview

The Associate Director, Legal Counsel will be a member of the Global R&D Legal practice area, supporting Research Development (ReDev), Development, and Global Technical Operations and Quality (TOQ). The primary focus will be supporting Development. This role reports to the Vice President, General Counsel, Research & Development.

This is a virtual/hybrid role requiring periodic in-person engagement in Alnylam’s Cambridge, MA or Maidenhead, UK offices.

Key Responsibilities

• Provide legal and strategic advice on global clinical programs, including interpretation of laws/regulations in over 50 countries.
• Serve as in-house expert on EU and UK laws/regulations impacting clinical trials, with expertise in IVDR regulations a plus.
• Participate as a legal member on program-related and operational boards, assessing legal risks related to product liability, ethics, privacy, and compliance.
• Review clinical documents such as protocols, consents, and investigator brochures.
• Advise on legal risks related to legislation and government actions affecting clinical programs.
• Support Clinical Operations and Clinical Quality Assurance in investigations and regulatory reporting.
• Manage contractual issues for clinical trials and clinical documents.

Overall Legal Support

• Collaborate with global legal teams to support R&D functions.
• Interpret contracts, support third-party relationships, and contribute to legal policies and processes.
• Partner with IP and Business Development Legal teams on related issues.

Qualifications

• Juris Doctor degree required.
• At least 6 years of legal experience advising on R&D, including clinical, regulatory, and safety aspects.
• Expertise in EU and UK clinical trial laws; experience with IVDR regulations is a plus.
• Experience drafting and negotiating R&D agreements and supporting global clinical trials.
• Strong communication skills and ability to work across organizational levels.

About Alnylam

Alnylam Pharmaceuticals is a leader in RNA interference (RNAi) therapeutics, committed to transforming lives through innovative medicines based on Nobel-winning science. Founded in 2002, Alnylam continues to lead the RNAi revolution.

Our Culture

We foster a people-first, inclusive environment guided by values of innovation, urgency, excellence, and respect. Recognized globally as a top employer, we are committed to diversity, equity, and inclusion.