Director, Ethics and Compliance

 This role is considered Hybrid.

Overview

Reporting to the Vice President, U.S. TTR, Ethics and Compliance, this director-level position is responsible for helping lead and oversee Alnylam’s Compliance Program in the U.S. with responsibility for the Strategic Accounts, Market Access, Patient Services, and Medical Outcomes Scientific Liaison functions within the U.S. TTR Business Unit.  The candidate in this role will partner closely with key stakeholders throughout the US TTR Business Unit, Legal, and Ethics & Compliance colleagues, leadership to help build a best-in-class Compliance Program.  This role will be responsible for helping to design and implement compliance policies and procedures, systems, processes, training, communications, and monitoring to identify and mitigate potential risk areas to enhance the effectiveness of Alnylam’s Compliance Program for the U.S. TTR Business Unit.

This position is hybrid and will be primarily located in Cambridge, MA.

Key Responsibilities

• Provide compliance guidance and counseling to the business and stakeholders on traditional and novel business activities and associated risks, and relevant compliance policies and processes in accordance with laws, regulations, industry guidance, and trends;
• Develop and maintain trusting relationships with commercial and medical field-based personnel by serving as a trusted advisor and resource;
• Develop and deliver appropriate training, communication, and direction as it relates to Alnylam’s Code of Business Conduct and Ethics, Alnylam’s Core Values, and applicable policies, procedures, and guidance;
• Conduct live and desktop monitoring to ensure business partner compliance with applicable policies, procedures, and guidance;
• Draft compliance policies, procedures, and guidance to ensure consistent application of Alnylam’s Compliance Program and to comply with applicable U.S. laws and regulations, including: federal and state antikickback and false claims laws; the federal Food and Drug Cosmetic Act (FDCA); federal and state transparency laws; Food and Drug Administration (FDA) laws and regulations; Centers for Medicare and Medicaid (CMS) regulations; Office of Inspector General (OIG) guidance; and the PhRMA Code on Interactions with Health Care Professionals (PhRMA Code);
• Partner with the Global Compliance Operations team to implement compliance systems and tools to enhance Alnylam’s Compliance Program, including training programs, approval processes, and a fit-for-purpose monitoring program, including field-based and desktop monitoring, that leverages technology to provide insights, and to help identify and mitigate potential risks; 
• Support U.S. transparency reporting and processes for transparency reporting requirements to comply with the Physician Payments Sunshine Act (Sunshine Act), working closely with key business stakeholders and the Global Compliance Operations team;
• Contribute to and participate in compliance committees and other relevant governance forums, as needed;
• Assist with internal investigations conducted by the Head of Global Investigations/ERM and support audit and/or investigation remediation, working closely with business stakeholders, Internal Audit, Legal, and other cross-functional business partners, as necessary;
• Partner with stakeholders across the US TTR Business Unit and the broader enterprise to strengthen Alnylam’s focus on Open Door/Speak Up campaigns, and enhancing the culture of compliance across Alnylam;
• Keep updated on compliance and regulatory developments, and the U.S. enforcement landscape.

Qualifications

• 8-10+ years’ legal and/or compliance experience in a pharmaceutical or biotechnology company with a focus on compliance business partnering;
• A law degree is preferred;
• Demonstrated ability to collaborate and influence cross-functionally and experience working in a matrixed business environment;
• Direct experience in designing, implementing, and improving compliance programs, including policies and training; compliance systems and tools; transparency reporting; risk assessments; data analytics and monitoring is preferred;
• Comprehensive knowledge of U.S. healthcare fraud and abuse laws including: state and federal antikickback and false claims laws; anticorruption laws such as the U.S. Foreign Corrupt Practices Act; FDA, OIG, and CMS rules, regulations, and guidance; Sunshine Act requirements; and relevant industry codes on interactions with healthcare professionals, such as the PhRMA Code;
• Demonstrate a strategic, enterprise mindset and exhibit a practical, innovative, solutions-oriented approach;
• Work as a collaborative, team player with a strong focus on partnership;
• Must be able to work in a team environment with a wide variety of company personnel on a broad range of matters;  
• Ability to manage multiple tasks simultaneously, to work independently and manage discrete areas of responsibility with limited supervision, and to flourish in a fast-paced environment;
• Ability to thrive in a proactive ethical culture in which compliance and business objectives are mutually reinforcing;
• Strong motivation and ability to champion a comprehensive compliance program that is integrated with Alnylam’s business and culture;
• Excellent organizational and time management skills, and strong communication skills (verbal and written) with fluency in written and spoken English required, including the ability to communicate persuasively throughout all layers of an organization;
• Strong commitment to ethics and integrity in all aspects of their work;
• Travel will be required on occasion to Alnylam offices in the U.S. and overseas.

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 the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, 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. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.