Lead - Clinical Operations

November 29

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Amylyx Pharmaceuticals

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ALS • Neurodegenerative Diseases • Amyotrophic Lateral Sclerosis

201 - 500 employees

Founded 2020

🧬 Biotechnology

💊 Pharmaceuticals

Description

• The Lead, Clinical Operations is responsible for managing clinical studies in Post-Bariatric Hypoglycemia (PBH), ALS, PSP, Wolfram Syndrome and/or other diseases under study at Amylyx Pharmaceuticals. • Reporting to the Head Clinical Operations, you will manage day-to-day operations of global trials with little supervision in a small fast-paced company environment. • You are a seasoned clinical operations trial manager, comfortable working independently and experienced managing cross-functional activities internally and externally. • You enjoy working against the clock and beating timelines, with a keen eye for quality. • As an integral senior member of the Amylyx Global Clinical Operations team you possess strong vendor management skills with deep experience managing full-service CROs and leading and/or collaborating with internal cross functional teams. • You preferably have experience with managing a Decentralized Clinical Trial setting, working with remote data collection via event-Diary and wearable devices. • You are a proactive problem-solver with proficient verbal and written communication skills, comfortable leading study teams working with ambitious timelines.

Requirements

• BS/BA Degree, in science or a health-related field is preferred • Minimum 8 years of clinical operations experience in a pharmaceutical/biotech, and/or CRO setting; • Experience and understanding of global clinical trial operations; study startup through close-out; strong vendor management skills; inspection-ready mindset • Effective project management skills with a demonstrated ability to provide critical and timely insight, and analytical problem-solving skills • Ability to manage competing priorities, is detail-oriented and comfortable multi-tasking • Exceptional knowledge of GCP, ICH and FDA regulations • Must be able to travel up to 20%, domestically and internationally • Ability to work independently in a rapidly changing, small company environment and comfortable making risk-based decisions • Therapeutic experience in rare diseases or CNS conditions is preferred