Vice President, Clinical Compliance and Systems

<div class="content-intro"><p>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).</p> <p>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.</p></div><p><strong>The Opportunity</strong></p> <p><span data-contrast="auto">Amylyx is seeking an experienced and strategic </span><strong><span data-contrast="auto">Vice President, Clinical Compliance & Systems</span></strong><span data-contrast="auto"> to join our Clinical Operations leadership team. This newly created role will provide leadership and vision for two increasingly important capabilities within Clinical Operations: </span><strong><span data-contrast="auto">Clinical Compliance and Clinical Systems</span></strong><span data-contrast="auto">. In this role, “systems” refers to the operating model of Clinical Operations — the processes, governance, standards, tools, data practices, workflows, and oversight mechanisms, including the business use of clinical platforms, that support compliant, efficient, and scalable clinical trial execution.</span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">As Amylyx continues to advance and expand its clinical development portfolio, we are evolving our Clinical Operations model to build greater internal capability, strengthen oversight of clinical trial execution, and implement scalable processes and systems that enable high-quality, compliant, and data-driven decision making.</span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">The Vice President, Clinical Compliance & Systems will be responsible for establishing and advancing the strategy, infrastructure, processes, and capabilities required to support this evolution. The individual will oversee clinical compliance, inspection readiness, Trial Master File (TMF) strategy and governance, and the development and implementation of clinical systems and technologies supporting Clinical Operations.</span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">This leader will partner closely across Clinical Operations, Development Sciences, Quality, IT, and other functions to ensure Amylyx’s clinical operating infrastructure evolves with the needs of its programs and pipeline. This is an opportunity for a highly collaborative leader to </span><strong><span data-contrast="auto">build and shape a growing function</span></strong><span data-contrast="auto">, balancing strong compliance and operational discipline with innovation, agility, and fit-for-purpose solutions.</span><span data-ccp-props="{}"> </span></p> <p><strong>Responsibilities</strong></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Provide stra