Vice President, Compliance

Amylyx Pharmaceuticals•Cambridge, MA

1d•Remote

About The Position

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply. The Opportunity Amylyx is seeking an experienced and business-oriented compliance leader to serve as Vice President, Compliance. Reporting to the Senior Vice President, Deputy General Counsel & Compliance Officer, this individual will help design, implement, and continuously enhance a comprehensive healthcare compliance program as the company prepares for commercial launch and rapid growth. The Vice President, Compliance will play a critical leadership role in fostering a culture of integrity and accountability, establishing a launch-ready compliance infrastructure, and serving as a trusted advisor to business leaders across the organization. The successful candidate will combine strategic vision with operational excellence, demonstrating the ability to build programs, influence stakeholders, and execute effectively in a dynamic biotechnology environment.

Requirements

Bachelor’s degree required; Juris Doctor, Masters and/or Compliance Certification (CCEP), or comparable professional qualifications strongly preferred.
Minimum 12 years of relevant healthcare compliance experience in the biotechnology, pharmaceutical, medical device, and/or life sciences industry, with demonstrated experience designing, implementing, and/or enhancing healthcare compliance programs.
Experience supporting one or more U.S. pharmaceutical product launches preferred.
Excellent leadership and interpersonal skills, a problem-solving mindset, and ability to thrive in a fast-paced environment.
Excellent project management skills with the ability to manage multiple priorities simultaneously and drive execution.
Strong oral and written communication and presentation skills, and professionalism to handle sensitive matters confidentially and with discretion.
Demonstrated commitment to ethics, integrity, and values-based leadership.
Ability to travel approximately 15-20% of time.

Nice To Haves

Juris Doctor, Masters and/or Compliance Certification (CCEP), or comparable professional qualifications strongly preferred.
Experience supporting one or more U.S. pharmaceutical product launches preferred.

Responsibilities

Build a compliance program consistent with industry standards and regulatory expectations, including policies and procedures, training and communications, auditing and monitoring, investigations, corrective actions, and ongoing risk assessment.
Partner with the Executive Leadership Team and Board to establish and reinforce a strong tone from the top, embedding compliance and ethical conduct into leadership communications, business operations, strategic initiatives, and organizational culture.
Drive the Company’s Compliance Committee and compliance reporting to the Board and Audit Committee.
Serve as a strategic advisor to commercial, medical, and other functions to ensure launch activities are conducted in compliance with applicable legal, regulatory, and industry requirements.
Build compliance operations, including transparency reporting, fair market value processes, grants and sponsorship review, third-party due diligence, conflict-of-interest processes, investigations, and monitoring activities.
Conduct compliance investigations and ensure appropriate corrective and preventive actions are implemented.
Develop and lead the Company's compliance training and communications strategy, translating legal and regulatory requirements into practical, business-relevant guidance.
Conduct ongoing compliance risk assessments and periodically evaluate the effectiveness of the Company's compliance culture, recommending enhancements based on business needs, emerging risks, and regulatory expectations.
Partner with the Deputy General Counsel to execute and evolve the Company’s Enterprise Risk Management program.
Help build and mentor a high-performing compliance organization and foster a culture of collaboration, accountability, and continuous improvement.