- Experience
- 5+ yrs
- Salary
- USD 211,000 – USD 237,000 / year
- Openings
- 1
- Posted
- 1 day ago
- Work mode
- Work from home
- Education
- Advanced degree (PharmD, PhD or equivalent)
- Resume
- Required to apply
Job description
About Amylyx Pharmaceuticals
Amylyx Pharmaceuticals is focused on pioneering treatments for diseases with substantial unmet needs, including post-bariatric hypoglycemia, Wolfram syndrome, and amyotrophic lateral sclerosis. The company fosters a culture anchored on core values: audacity, curiosity, authenticity, engagement, and accountability, dedicated to serving communities urgently requiring medical advancements.
Role Overview
The Director of Medical Information will lead global medical information operations at Amylyx, initially concentrating on building and expanding US Medical Information capabilities in preparation for product launch. This role involves defining strategic direction and operating frameworks, managing content development and inquiry handling, overseeing vendors and contact centers, ensuring quality and compliance, generating insights, and partnering across multiple functions for scientific exchange and launch success.
Key Responsibilities
- Establish and grow the Medical Information function including strategy, processes, infrastructure, focusing on US launch readiness and global scalability.
- Manage creation, approval, maintenance, and dissemination of medical information resources such as standard response letters, FAQs, scripts, payer-facing dossiers, and tailored responses.
- Oversee vendor and contact center partnerships including training, performance management, quality assurance, budget oversight, and continuous enhancements.
- Guarantee scientific accuracy, balance, evidence basis, and compliance in all medical information communications per relevant regulations and standards.
- Participate in Medical, Legal, and Regulatory review processes and other interdisciplinary forums as a Medical Affairs representative.
- Analyze inquiry data and customer feedback to identify content gaps and generate actionable insights for Medical Affairs and cross-functional teams.
- Support Medical Affairs involvement in scientific conferences and medical congresses with content preparation, inquiry management, insight collection, and scientific exchange assistance.
- Collaborate with Medical Affairs, Clinical Development, Pharmacovigilance, Commercial, and other teams to ensure compliant scientific communication, readiness for product launch, and appropriate escalation of concerns.
Required Qualifications
- Advanced clinical or scientific degree (e.g., PharmD, PhD).
- At least five years of relevant experience in the biotech/pharmaceutical sector, especially within Medical Information or Medical Affairs.
- Experience in leading Medical Information strategy, content development, inquiry management, vendor oversight, quality control, reporting, and launch planning.
- Strong knowledge of regulatory, compliance, pharmacovigilance, and product complaint standards affecting scientific exchanges with diverse stakeholders.
- Excellent written and verbal communication skills, capable of interpreting complex scientific material and delivering accurate, balanced, evidence-supported responses tailored appropriately.
- Proven cross-functional leadership and stakeholder management skills with ability to influence, manage competing tasks, and adapt in dynamic settings.
- Ability to develop and communicate Medical Information metrics, KPIs, and actionable insights to guide business decisions.
- Competency with Medical Information systems, document management, Microsoft Office, Veeva Vault, Veeva CRM, Adobe Acrobat, or comparable platforms.
Preferred Qualifications
- Experience in product launch support, lifecycle management, and expanding Medical Information capabilities across geographies or therapeutic areas.
- Background in rare diseases, endocrinology, metabolic diseases, neurology, or related fields.
- Leadership experience in people management, including recruitment, coaching, and guiding teams and vendors.
Work Location and Conditions
- Remote work is supported within the US, excluding residents of Alaska, Arizona, Hawaii, Michigan, and Tennessee due to health insurance and tax regulations.
- Requires occasional travel to Cambridge, MA corporate office and attendance at company events as necessary.
- Remote work setup must support privacy, reliable internet, phone capabilities, and video conferencing.
Compensation
Estimated salary ranges from $211,000 to $237,000 USD annually. Actual offer may vary based on qualifications and internal equity considerations.
Equal Opportunity Statement
Amylyx Pharmaceuticals is an equal opportunity employer committed to inclusive and nondiscriminatory hiring and employment practices. Accommodations are available for candidates requiring them during the selection process.
Legal Notice
In Massachusetts, applicant lie detector tests are illegal and subject to penalties.