Amylyx Pharmaceuticals Looking for Head, Global Compliance & Business Partnering at Cambridge, MA Full Time

Amylyx was started in 2013 by two Brown University students who had an ambitious goal: to improve the lives of people with neurodegenerative diseases by addressing the root cause. Their research and close collaboration with the ALS community ultimately resulted in our first commercial product, which is now approved in the U.S. and conditionally approved in Canada.

At Amylyx, we’re bringing together talented people like you who are guided by our values to be Audacious, Curious, Authentic, Engaging and Accountable in the fight against neurodegenerative diseases like, ALS, Alzheimer’s disease, Wolfram Syndrome and others.

Rediscover your purpose and reimagine your career at a company whose founders, mission, and culture are unlike any other in life sciences—in all the best ways.

Recent milestones include:

• The U.S. Food and Drug Administration (FDA) approved RELYVRIO™ in September of 2022
• Health Canada approved ALBRIOZA™ with conditions in Canada in June of 2022
• AMX0035 is currently under review with the European Medicines Agency
• 280 employees globally, with headquarters in Cambridge, MA, US and Amsterdam, the Netherlands — and growing strong!

POSITION SUMMARY:

Amylyx’s Global Compliance function is responsible for developing, implementing, and monitoring the operation of the Company’s healthcare Compliance Program, including Compliance policies, training, auditing and monitoring, reporting, investigations, and remediation. The Head, Global Compliance Operations and Business Partnering, will report to the Head, Deputy General Counsel & Global Compliance Officer, and will serve as a collaborative partner to the business and play a key role in evolving the Compliance function at a newly commercialized and globally expanding company.

RESPONSIBILITIES:

• With Global Compliance Officer, developing and implementing Compliance program strategy, including Compliance communications strategy to foster a values-based culture.
• Developing and delivering practical training and serving as go-to point of contact to the business.
• Leading fit-for-purpose adaptation of Compliance program for globally expanding company, including in EMEA, APAC, and LATAM.
• Leading improvement of Compliance operations (e.g., fair market value analyses, and grants and sponsorship review and approval processes).
• Independently managing outside counsel and/or compliance consulting external resources.
• Designing, managing, and overseeing compliance with U.S. (state and federal) and global transparency reporting requirements.
• Leading growth of the company’s anti-bribery and anti-corruption program, including through auditing and monitoring and third-party risk management.
• Developing and implementing auditing and monitoring plans, and conducting auditing and monitoring activities and reporting.
• Assisting with Enterprise Risk Management program, including monitoring of controls and mitigations progress.
• Independently conducting compliance investigations and remediation.

Requirements

• Bachelor’s degree; and Juris Doctor, Masters and/or Compliance certification, or substantial experience at compliance consulting or accounting firm.
• 15+ years of healthcare compliance experience with a focus on the biotechnology/pharmaceutical industry.
• Desire to both lead on strategic matters and “roll up sleeves” to implement day-to-day Compliance operations.
• Excellent leadership and interpersonal skills and ability to thrive in fast-paced environment.
• Excellent analytical and problem-solving skills.
• Experience independently conducting investigations on sensitive matters.
• Auditing and monitoring and compliance operations experience, including demonstrated ability to identify areas for improvement in controls, systems, and processes.
• 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 confidentiality and with discretion.
• Demonstrated commitment to compliance, ethics, and accountability.
• Ability to travel approximately 15-20% of time.

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Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.