Legal Director, Global Medical Affairs & Pipeline

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, whether 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.

U.S. Pay Range

$210,000.00 - $299,000.00

The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.

Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers

AboutAlnylam

We are the leader in RNAi therapeutics- a revolutionaryapproach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possibleand are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, wherean authentic, inclusive culture and breakthrough thinkingfuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.