Amylyx Pharmaceuticals

Amylyx Pharmaceuticals specializes in providing solutions for Alzheimer’s and other diseases of the brain.

251-500 employees

Founded 2014

$246.3M post ipo equity

Pharmaceutical

Public Company

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Pharmaceutical Biotechnology Medical Neuroscience

Hybrid Work Model

This company offers a hybrid work model combining remote and office work. Team members are distributed across the U.S. and Canada.

Open Positions1

You must reside and work within the United StatesAnd in a state where Amylyx currently does businessFull-TimeBiotechnologyPosted

Associate Director, Clinical Compliance & Records

Provide guidance to Study Management Teams on ICH-GCP standards, FDA guidelines, and regulatory requirements.
Manage study-related risks, lead investigations, and support CAPA activities.
Partner with cross-functional teams to manage Quality Events, risk assessments, and sponsor oversight documentation.
Facilitate inspection readiness activities, including preparation, participation, and follow-up for regulatory inspections.
Provide leadership for Clinical Records strategy, including eTMF processes, migrations, and TMF plan development.
Monitor TMF health, provide metrics, and ensure TMF content meets quality standards.
Collaborate with internal and external stakeholders to resolve TMF quality issues and implement process improvements.

SharePointMicrosoft OfficeProcess improvement

About Amylyx Pharmaceuticals

Amylyx Pharmaceuticals pioneers solutions for neurodegenerative diseases like ALS and Wolfram syndrome. You will join a team crafting investigational therapies to meet high unmet medical needs. The company has secured $448 million in funding across 8 rounds, demonstrating strong investor confidence. You can contribute to critical clinical trials for conditions like post-bariatric hypoglycemia, making a tangible difference.

How We Work

You will join a mission-driven culture valuing audacity, curiosity, authenticity, engagement, and accountability. We empower you to tackle tough medical problems with urgency and rigorous science. Our team fosters connection through three annual in-person "Anchor Weeks" and bi-weekly "Amylyx Exchange" meetings. This hybrid approach balances focused remote work with vital collaborative moments. You must reside and work within the United States.

Why Join Us

Pioneer solutions for challenging neurodegenerative and endocrine conditions.
Contribute to multiple therapies in various clinical trial phases.
Work in a hybrid remote model, balancing flexibility with team connection.
Join a team committed to a bold mission, backed by significant funding.
Your efforts will directly impact communities with high unmet medical needs.

Benefits & Perks

Competitive salary range of $171,000 to $192,000 USD for the Associate Director role.
5% 401(k) employer contribution to secure your financial future.
Comprehensive medical plans offering extensive coverage and flexibility.
Employee Assistance Program (EAP) for mental health, work-life, financial, and legal support.
Dedicated Learning and Development Program to foster your growth.

Tech Stack

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