Director Medical Information in Cambridge

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – create a culture of caring. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply.

The Director, Medical Information will serve as the functional lead for Amylyx’s global medical information function, reporting to the Director, Medical Affairs. The initial focus of the role will be establishing and scaling U.S. Medical Information capabilities in support of launch readiness, with the expectation that the function and operating model will evolve to support broader global needs over time. The Director will define and execute the global Medical Information strategy and operating model.

Responsibilities include:

• Build and scale Amylyx's Medical Information function, including strategy, operating model, capabilities, infrastructure, and roadmap, with an initial focus on U.S. launch readiness and a foundation for future global expansion.
• Oversee the development, approval, maintenance, and deployment of Medical Information content, including standard response letters, FAQs, scripted responses, templates, tailored responses for unsolicited inquiries, AMCP dossiers, and other payer-facing scientific resources.
• Select and manage Medical Information vendors and contact center partners, including training, performance objectives, KPIs, quality monitoring, corrective actions, budget tracking, and continuous improvement.
• Ensure Medical Information responses are scientifically accurate, balanced, evidence-based, and compliant with applicable regulations, SOPs, and industry standards.
• Represent Medical Affairs in Medical, Legal, and Regulatory (MLR) review processes and other cross-functional review forums as appropriate.
• Monitor inquiry trends, metrics, and customer insights to identify unmet content needs and generate actionable insights for Medical Affairs and cross-functional stakeholders.
• Support Medical Affairs activities related to scientific conferences and medical congresses, including content preparation, congress inquiry management, insight gathering, and scientific exchange support as appropriate.
• Partner cross-functionally with Medical Affairs, Field Medical, Scientific Communications, Clinical Development, Pharmacovigilance/Drug Safety, Quality, Commercial, Market Access, Patient Support, and other teams to support compliant scientific exchange, launch readiness, operational excellence, and appropriate escalation of inquiries, adverse events, and product quality complaints.

Required Qualifications:

• Advanced scientific or clinical degree required, such as (e.g., pharmD, PhD).
• 5+ years of relevant experience in the biotechnology or pharmaceutical industry, including substantial experience in Medical Information, Medical Affairs, or a related scientific function.
• Direct experience leading Medical Information strategy, content development, inquiry management, vendor/contact center oversight, systems, quality monitoring, reporting, and launch planning.
• Strong understanding of regulatory, compliance, pharmacovigilance, and product complaint requirements governing scientific exchange with healthcare professionals, patients, caregivers, and other external stakeholders.
• Excellent written and verbal communication skills, with the ability to interpret complex scientific information and deliver accurate, balanced, evidence-based, and appropriately tailored responses.
• Demonstrated cross-functional leadership, stakeholder management, and project management skills, including the ability to influence without direct authority, manage competing priorities, and operate effectively in a dynamic environment.
• Experience developing and communicating Medical Information metrics, KPIs, and actionable insights to inform business decisions.
• Proficiency with Medical Information systems, document management platforms, Microsoft Office, Veeva Vault, Veeva CRM, Adobe Acrobat, or similar technology platforms.

Preferred Requirements:

• Experience supporting product launches, launch readiness, lifecycle management, and the evolution of Medical Information capabilities across products, regions, or therapeutic areas.
• Experience in rare disease, endocrinology, metabolic disease, neurology, or other relevant therapeutic areas.
• Demonstrated people leadership experience, including the ability to recruit, develop, coach, and lead high-performing teams, vendors, and cross-functional partners.

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 a setting which enables meeting all requirements of the role (including 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: $211,000 - $237,000 USD.

Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, colour, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.