Associate Legal Director, Research and Development

Overview

The Associate Director, Legal Counsel will be a member of the Global R&D Legal practice area. Global R&D Legal supports three key Alnylam functions: Research Development (ReDev), Development, and Global Technical Operations and Quality (TOQ). This role's primary focus will be supporting Development. This role will report to the Vice President, General Counsel, Research & Development.

This is a hybrid/remote role that requires periodic in-person engagement with legal colleagues and business partners in either Alnylam's Cambridge, MA or Maidenhead, UK office.

Key Responsibilities

Legal Support for Development

Development currently has 9 active clinical programs with expected new clinical programs in the coming year (approximately 10 studies in planning or soon to be initiated). Clinical trials are currently being conducted in 50+ countries, with a focus on the US, Canada, UK and EU member states. R&D Legal provides legal and strategic advice associated with these global clinical program strategies (including Regulatory, Development, Global Patient Safety & Risk Management, Clinical Operations, Data Sciences).

• Partner with Vice President, General Counsel, Research & Development and Legal Director in providing timely legal and strategic advice to Development including the following:

• Interpretating laws/regulations/guidance in any of the 50+ countries where Alnylam clinical trials are conducted or where Alnylam has legal and/or regulatory obligations in carrying out its clinical programs. Advising on any associated risks in complying with such laws/regulations/guidance.

• Serve as in-house expert in EU and UK laws/regulations impacting global clinical trials. Expertise in advising on in vitro diagnostic regulations (e.g. IVDR regulations) a plus.

• Serve as legal member on program-related and operational boards/committees, as assigned. Assessing clinical programs and strategy, as well as, underlying policies and procedures, for any legal risks associated with product liability, fraud & abuse, human subject research protections/ethics, privacy, regulatory compliance.

• Escalate safety issues to the Vice President, General Counsel, Research & Development to jointly assess legal risks.

• Review key clinical documents (e.g. protocols, consents, investigator brochures).

• Advise on risks associated with government actions or pending, new or existing legislation impacting global clinical programs.

• Provide legal support to ClinOps and Clinical QA in assessing allegations, conducting investigations, and meeting legal/regulatory reporting requirements.

• Serve as legal contact for audits/inspections taking place in EU/UK.

• Serve as escalation point for all contractual issues arising from assigned clinical trials (i.e. CDAs, CTAs, country-specific documents, etc.).

• Serve as escalation point for informed consents and similar clinical trial documents for assigned studies.

Overall Legal Support for Alnylam's R&D Functions (ReDev, Development)

• Partner with Global R&D Legal colleagues to provide comprehensive legal support to Alnylam's R&D functions.

• Provide legal, business and strategic advice on relationship support by interpreting contract language for internal business partners to help avoid and/or resolve potential issues. Also, partner with business partners on managing third party relationships.

• Provide best-in-class legal support for policies, processes, templates, governance principles and support structures that allow Alnylam to successfully grow and scale globally.

• Partner with IP Legal and Business Development Legal to address potential IP issues and support Alnylam's relationships with collaborators, respectively.

• Partner cross-functionally and collaborate with business and legal stakeholders acting as enterprise connector to ensure global excellence, consistency and compliance with all R&D activities.

• Contribute to process improvements across our Legal department and organization, as needed.

• Identify and effectively communicate priorities and urgencies to applicable stakeholders.

Qualifications

• Juris Doctor degree required

• Minimum 6+ years' experience dedicated to advising on R&D functions (including Regulatory, Development, Global Patient Safety & Risk Management, Clinical Operations, Data Sciences) either in-house and/or a nationally recognized law firm).

• Expertise in EU and UK laws/regulations impacting global clinical trials.

• Working knowledge/experience advising on in vitro diagnostic regulations (e.g. IVDR regulations) a plus.

• Experience drafting and negotiating R&D agreements.

• Experience in partnering with R&D legal colleagues and business partners to provide advisory and strategic support to global clinical trials.

• Experience or knowledge in supporting Development organizations

• Demonstrated exceptional communication skills, including presentation, interpersonal interactions, and written communications

• Experience effectively working with all levels in the organization

• Demonstrated commitment to finding solutions, relationship building, continued learning, proactivity and a high sense of confidentiality

• Excellent interpersonal skills that are demonstrated by being articulate, direct and forthright, and serving as a collaborative and decisive team member and a strategic thinker with a broad perspective

• Ability to manage and prioritize multiple matters simultaneously and to respond to rapidly shifting priorities in ambiguous or challenging situations

• Willing to support any areas of Global R&D, as needed.

• Demonstrated ability to own projects and consistently meet tight timing requirements and high quality standards

• Strong verbal and written communication skills, including proven ability to interact and communicate effectively with individuals from multiple departments at all levels of the organization.

About Alnylam:Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by "interfering" with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture:Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we've been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK - among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.