Lead, Clinical Operations

Summary

Join Amylyx Pharmaceuticals as their Lead, Clinical Operations and manage clinical studies for neurodegenerative diseases like ALS and PSP. Reporting to the Head of Clinical Operations, you will oversee global trials, manage vendors, and ensure compliance. This senior role requires strong project management, problem-solving, and communication skills. The position offers a remote-friendly work environment within the US, with occasional travel to the Cambridge, MA office. You will be responsible for the conduct of trials from start-up to close-out, working with cross-functional teams and external partners. Amylyx values unconventional thinking and offers a unique culture in the life sciences industry.

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 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

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
• Ensure appropriate operational procedures are implemented or adhered to, to assure high quality trial data and operational excellence of assigned studies
• Develop, analyze, and report on metrics for clinical programs
• In conjunction with Clinical Leadership, ensure study deliverables are achieved on time and within budget
• Contribute to the development of study documentation including protocol review, study manuals, ICFs, CRFs, Clinical Study Reports etc
• Communicate trial status, issues, mitigations, and lessons learned to relevant cross-functional stakeholders, including senior leadership
• Be a stakeholder in CRO and vendor selection. Work with clinical operations leadership, clinical outsourcing, legal, and finance in the selection and contracting of CROs and vendors. Oversee and contribute to financial reporting for assigned projects including but not limited to PO management, projections, actuals and accruals
• Manage relationships and establish strong partnerships with CROs, vendors, investigators, and other external partners
• Address and/or escalate vendor performance issues; identify probable vendor risks and potential mitigation strategies
• Develop SOPs, work instructions, and standardized forms to define Clinical Operations processes within a growing team
• Provide leadership and support to direct report(s), if applicable, including mentoring, training, performance evaluation, and career development

Preferred Qualifications

Therapeutic experience in rare diseases or CNS conditions is preferred

Benefits

• 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