Lead – Clinical Operations

THE OPPORTUNITY

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. 

THE RESPONSIBILITIES

• Directly responsible for the conduct of the trials from start-up through close-out, with close attention to effective planning and execution, risk management, data integrity, quality and compliance with Company SOPs, ICH-GCP guidelines, GDPR, and other regulations and patient safety standards.
• Ensures appropriate operational procedures are implemented or adhered to, to assure high quality trial data and operational excellence of assigned studies.
• Develops, analyses, and reports on metrics for clinical programs.
• In conjunction with Clinical Leadership, ensures study deliverables are achieved on time and within budget.
• Contributes to the development of study documentation including protocol review, study manuals, ICFs, CRFs, Clinical Study Reports etc.
• Communicates trial status, issues, mitigations, and lessons learned to relevant cross-functional stakeholders, including senior leadership.
• Stakeholder in CRO and vendor selection. Works with clinical operations leadership, clinical outsourcing, legal, and finance in the selection and contracting of CROs and vendors. Oversees and contributes to financial reporting for assigned projects including but not limited to PO management, projections, actuals and accruals.
• Manages relationships and establishes strong partnerships with CROs, vendors, investigators, and other external partners.
• Addresses and/or escalates vendor performance issues; identifies probable vendor risks and potential mitigation strategies.
• Develops SOPs, work instructions, and standardized forms to define Clinical Operations processes within a growing team.
• Provides leadership and support to direct report(s), if applicable, including mentoring, training, performance evaluation, and career development.

REQUIRED QUALIFICATIONS

• 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 mind-set
• 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

WORK LOCATION AND CONDITIONS

• This is a remote friendly role, but you must reside and work within the United States, and in a state where Amylyx currently does business, to be considered. Any change in your remote location must be approved by Amylyx
• You will be required to follow Amylyx’s Remote Work Policy which includes:  
  • traveling to our corporate location in Cambridge, MA several times a year and attending other company-related events as necessary and requested, which may include travel by air, driving, or public transportation.
  • working in a setting that meets all requirements of the role (including privacy, reliable internet access, phone, ability to communicate via video conference, etc.) at your remote location
  • Information security protocols and steps to maintain confidentiality of Amylyx information, technology, and materials.