Note: The job is a remote job and is open to candidates in USA. Amylyx Pharmaceuticals is seeking a Director, Clinical Operations to lead the strategy, planning, execution, and oversight of assigned global clinical studies. The role provides end-to-end clinical trial leadership, manages external partners and study delivery, and collaborates with cross-functional teams to meet timelines, budget, quality, and compliance expectations.
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
Skills
- 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
- Ability to work independently in a rapidly changing, small company environment and comfortable making risk-based decisions
- BS/BA Degree, in science or a health-related field is preferred
- Therapeutic experience in rare diseases, Endocrinology or CNS conditions is preferred
Benefits
- Remote work opportunities within the United States; employees must reside and/or work outside Alaska, Arizona, Hawaii, Michigan, and Tennessee. Expected to travel to the corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested.
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