[Hiring] Director, Clinical Operations @Amylyx Pharmaceuticals

Role Description

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
• Amyotrophic Lateral Sclerosis (ALS)
• Wolfram Syndrome
• 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.

Qualifications

• 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.
• 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, with 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.

Requirements

• Provide end-to-end operational leadership and accountability for assigned global clinical trials for the full study lifecycle.
• 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.
• 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 protocols, study manuals, ICFs, CRFs, Clinical Study Reports, etc.
• Communicate trial status, issues, mitigations, and lessons learned to relevant cross-functional stakeholders, including senior leadership.
• Stakeholder in CRO and vendor selection; work with clinical operations leadership, clinical outsourcing, legal, and finance in the development of effective outsourcing strategies.
• 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), including mentoring, training, performance evaluation, and career development.

Benefits

• Remote work opportunities within the United States.
• Travel to corporate location in Cambridge, MA several times a year and attend other company-related events as necessary.
• Access to work in a setting that meets all role requirements (privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.

Compensation

The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate’s experience, skills, and qualifications, as well as considerations of internal equity.

Estimated Pay Range: $200,000 — $235,000 USD