Legal Director, Global Medical Affairs & Pipeline

The Legal Director, Global Medical Affairs & Pipeline will provide expert advice and strategic and tactical counseling to Global Medical Affairs teams to support compliance with applicable laws and regulations. This position will report to the Executive Director, Head of R&D Legal and will require you to work in a matrix setting in a fast paced, rapidly growing organization, partnering effectively with various stakeholders to mitigate legal risks, identify legal opportunities and enable strategic medical and scientific initiatives. This will include collaborating with colleagues in IP Legal, Corporate Transactions & Alliances Legal, Medical Affairs, New Product Commercialization, Regulatory, Ethics & Compliance (E&C), Privacy and other expertise areas at Alnylam.

You will provide day-to-day advisory counsel for Medical Affairs activities ranging across publications, congress activities, KOL engagement and advisory boards, grants and giving, medical research, and patient advocacy. You will be Legal representative on Medical Affairs strategies and tactics in the pipeline of the development cycle and knowledge-share with Commercial Legal colleagues, who primarily provide legal support to local Medical Affairs teams for marketed programs. In addition, you will partner with Global Medical Affairs members and be Legal point on certain key initiatives that span the product lifecycle. You will also advise cross-program Medical Affairs functions, such as Medical Research and Grants & Giving; be responsible for the associated agreements administered by those teams (e.g., global Medical Affairs grant, research collaboration, and investigator-initiated study contracts); and serve as a critical Legal representative on medical capabilities and E&C policies / procedures workstreams.

Summary of Key Responsibilities

Key activities and responsibilities of this role include, but are not limited to:

• Provide clear, practical legal advice and support to Medical Affairs on a wide range of activities, including scientific communications, medical education, publication planning, advisory boards and investigator-initiated studies
• Review and approve Global Medical Affairs materials, presentations and communications – primarily for pipeline and certain global / cross-prgoram activities, liaising with Regulatory and Medical reviewer colleagues as appropriate, to ensure compliance with laws and regulations
• Advise on interactions with healthcare professionals, scientific experts and patient advocacy groups, collaborating with E&C as appropriate, to ensure adherence to anti-kickback / anti-bribery and other compliance requirements
• Review and advise on global external funding requests to the Medical Affairs organization, such as grants, collaborations and investigator-initiated studies and draft, review and negotiate associated agreements
• Support the development and implementation of medical and E&C policies, standard operating procedures (SOPs) and training materials for Medical Affairs colleagues
• Monitor and interpret evolving laws, regulations and industry standards impacting medical affairs activities and proactively communicate changes to internal stakeholders
• Partner with E&C, Regulatory and other Legal colleagues to provide integrated legal risk assessments and solutions

Qualifications

• Exceptional oral and written communication skills, including drafting skills and presentation capabilities
• Excellent interpersonal and conflict resolution skills and ability to work in highly collaborative, team-oriented environment
• Ability to maintain an independent and objective perspective while developing and maintaining a strong partnership with the client organizations
• History of self-motivation, working independently on projects, meeting aggressive deadlines and juggling multiple matters
• High integrity and demonstrated ability to treat confidential information with great discretion
• Able to exercise good judgment, be forward looking and remain solution-oriented across a variety of situations
• JD from an ABA-accredited law school; admitted in good standing to at least one U.S. jurisdiction
• Minimum of 8 years post-JD experience advising on legal matters in a life sciences space, wether in a law firm or in-house in the biopharmaceutical industry or both
• Deep understanding of the pharmaceutical business and related legal issues and solid practice advising the pharmaceutical, biotech, healthcare or life sciences industry, including FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code, state and federal privacy laws and product liability laws. Working knowledge of the European general pharmaceutical legislation (Regulation 726/2004 and Directive 2001/83/EC) and the European legislation on medicines for children and for rare diseases (Regulation 1901/2006 and Regulation 141/2000/EC, respectively), as well as of the main industry codes (EFPIA, ABPI) a plus
• Experience working with Medical Affairs groups within biotech and pharma, including:
  • Reviewing materials for Medical Affairs teams to use with external stakeholders, such as healthcare professionals and patient advocacy groups; and
  • Setting up and supporting Medical Affairs research, negotiating with research institutions, and advanced contracting and redlining skills with strong attention to detail
• Excellent analytical, problem-solving and organizational skills to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards
• Ability to effectively and efficiently manage outside counsel and adhere to a budget

Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.

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.