The Opportunity

The Director, Clinical Operations is a senior member of the Amylyx Global Clinical Operations team responsible for the operational strategy, planning, execution, and oversight of assigned global clinical studies. Therapeutic areas may include: Post Bariatric Hypoglycemia or other associated conditions, Amytrophic Lateral Sclerosis (ALS), Wolfram Syndrome and/or other diseases under study at Amylyx Pharmaceuticals.

This individual will provide end to end operational leadership for clinical trials, working with a high degree of independence in a small, fast-paced company environment. The Director will translate program and study strategy into executable operational plans and ensure delivery against timelines, budget, quality and compliance expectations.

The ideal candidate is an experienced clinical operations leader with demonstrated success managing complex global clinical trials, CROs, functional service providers and specialty vendors. This individual is proactive, solutions oriented, comfortable making risk-based decisions, and able to identify emerging issues before they impact study execution.

The Director will work closely with Clinical Operations leadership, Clinical Development, Regulatory, Data Management, Biostatistics, Pharmacovigilance, Clinical Compliance, Quality, Clinical Outsourcing, Finance, Legal and other internal functions while providing strong oversight and direction to external partners.

This individual should be a proactive problem-solver with proficient verbal and written communication skills, comfortable leading study teams working with ambitious timelines. The ideal candidate will also have previous experience managing clinical operations team members, and helping to shape their growth and development.

Responsibilities

• Provide end-to-end operational leadership and accountability for assigned global clinical trials for the full study lifecycle 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.
• Oversee development and maintenance of integrated study operational plans, including timelines, enrollment assumptions, resource requirements, key dependencies, risks and contingency plans.
• Drive execution against study milestones, proactively identifying risks, issues, trends, and interdependencies and ensuring appropriate mitigation, escalation and resolution.
• 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 protocols, 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 development of effective outsourcing strategies, including 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.

Requirements

• BS/BA Degree, in science or a health-related field is preferred.
• Minimum of 12 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
• Experience with Remote Data Acquisition tools and requirements for decentralized study requirements. Comfortable with technology deployment and management in a clinical trial setting.
• Ability to manage competing priorities, detail-oriented and comfortable multi-tasking.
• Exceptional knowledge of GCP, ICH and FDA regulations and guidances.
• Must be able to travel up to 20%, primarily domestically, potential for international travel
• Ability to work independently in a rapidly changing, small company environment and comfortable making risk-based decisions.
• Therapeutic experience in rare diseases, Endocrinology or CNS conditions is preferred.

Work Location and Conditions

• At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii, Michigan and Tennessee.
• You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested.
• You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.