Head, Clinical Operations (Early Phase)

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
• 350 employees globally, with headquarters in Cambridge, MA, US and Amsterdam, the Netherlands -- and growing strong!
• AMX0035 is currently under review with the European Medicines Agency
• Health Canada approved ALBRIOZA™ with conditions in Canada in June of 2022

Position Summary

The Head, Clinical Operations will contribute to overall clinical strategy, with initial focus on design and execution of Amylyx's Early Phase clinical trials. This position will have direct responsibility for oversight of planning and execution of assigned clinical programs, ensuring alignment of timelines, budgets, program objectives and key deliverables. Reporting to the Global Head of Clinical Operations this individual will be an integral member of the Clinical Operations Leadership team, making impactful contributions to all assigned Amylyx Clinical programs and will interact with clinical study project teams, cross functional partners, and external stakeholders including alliance partners and vendors.

Responsibilities

• Directs the overall operational strategy of assigned clinical programs, with direct responsibility for oversight of planning and execution, ensuring alignment of timelines, budgets, program objectives and key deliverables.
• Partners with Clinical Development, Biostatistics, Clinical Pharmacology, Regulatory and other stakeholders in establishing clinical strategy and clinical development plans, as well as other study specific documents such as protocols, reports, plans, consents, etc.
• Provides supervisory support in CRO and vendor selection. Works with clinical outsourcing, legal, and finance in the selection and contracting of CROs and vendors.
• Serves as a leader and provides support to direct report(s) including mentoring, training, performance evaluation, and career development.
• Oversees the conduct of the trials from start-up through close-out, with close attention to planning and milestones, risk management, data integrity, quality and compliance, and strategic planning.
• Manages relationships and establishes strong partnerships with CROs, vendors, investigators and other external partners.
• Manages, motivates and coaches clinical study teams to plan, implement and execute global clinical research studies with high quality, within budget and on schedule, keeping patient perspective in mind.
• Establishes operational performance goals and targets, and develops, analyses, and reports on metrics for clinical programs.
• Addresses and/or escalates vendor performance issues and ensures appropriate resolution to identified issues; works with vendors and project teams on effective risk management, with a focus on quality project delivery.

Requirements

• Expert level knowledge of early phase clinical studies, including vendors and other service providers to ensure optimal study execution.
• BA/BS degree with at least 15 years biotech/pharmaceutical industry experience preferred in a Clinical Operations environment.
• Expert level knowledge of GCP, ICH, FDA and other regulations that govern the conduct of clinical trials.
• Understands and successfully navigates the complexity of building operational strategies to achieve clinical study objectives.

Preferred Qualifications

• Thrives in a fast-paced environment.
• Direct experience with the transition of assets into early phase research; develops innovative approaches to accelerate early phase study execution.

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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.