Amylyx Pharmaceuticals
Senior Director, Health Economics and Outcome Research/Real World Evidence
Amylyx Pharmaceuticals, Cambridge, Massachusetts, United States, 02141
Senior Director, Health Economics And Outcome Research/Real World Evidence
Amylyx is a clinical-stage pharmaceutical company based in Cambridge, Massachusetts, with an audacious mission to develop novel therapies for high unmet needs. We are currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS). Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. 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. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and determination, we encourage you to read the opportunity below and apply. The Opportunity
The Senior Director, Health Economics And Outcomes Research (HEOR)/Real World Evidence (RWE) at Amylyx Pharmaceuticals will report to the SVP of Medical Affairs. This position will be an expert and experienced leader, engaging cross functionally to develop and drive HEOR and evidence generation strategies. The Senior Director will play an integral role in developing and communicating the value proposition for Amylyx' assets, including our lead program in post-bariatric hypoglycemia (PBH). This role will drive development of strategies, methods, and tools to ensure successful market access, adoption, and long-term impact in support of Amylyx' mission to find solutions for patients with high unmet needs. Responsibilities
Strategic Leadership Build and lead the HEOR function including the development of integrated HEOR and evidence generation strategies and tactical plans to support Amylyx's therapeutic programs Lead evidence gap analyses that will inform the HEOR strategic and tactical plans and lead cross-functional data generation and communication planning efforts to support health economic/value proposition and inform understanding of treatment patterns, disease burden, patient-reported outcomes, and unmet needs Evidence Generation & Study Execution Design and execute projects, such as burden of illness, real-world clinical outcomes, clinical registries, retrospective database analyses, and meta-analyses. Provide scientific support for protocol development, target product profiles, data collection strategies, literature review and evidence synthesis Stakeholder Engagement & Communication Oversee the development of peer-reviewed publications, conference presentations, and internal communication of HEOR findings. Support global market access strategy and plans for Amylyx pipeline products including, identifying opportunities for early scientific advice with key health technology assessment (HTA) agencies, regulatory support and preparing for global HTA models. Incorporate any recommendations into the clinical development program. Cross-Functional Collaboration Ensure all HEOR tactics are aligned cross-functionally with business strategies and regulatory guidelines. Monitor and interpret U.S. policy changes (e.g., IRA, CMS guidance) and translate implications into actionable HEOR strategies. Collaborate with Market Access and Medical Affairs to develop and maintain evidence packages tailored to U.S. payers, including commercial plans, Medicare, and Medicaid. Team & Vendor Management Lead vendor selection and manage external research partners to ensure high-quality and timely study delivery. Build and manage a team to support innovative real-world evidence generation and health economics research. Manage HEOR budget planning and resource allocation to ensure efficient execution of strategic priorities Required Qualifications
10+ years healthcare or pharmaceutical industry experience with minimum 7 in HEOR Master's Degree (MS, MPH, PharmD, PhD) in a relevant discipline (e.g., health economics, medicine, pharmacy, public health, epidemiology) required Demonstrated success in designing and leading real-world research to support US payer value and access. Experience supporting HEOR strategy for product launch, including pre-launch evidence generation and payer engagement, is highly desirable. Deep understanding of U.S. healthcare system dynamics, including payer structures, value-based care, and regulatory trends. Excellent leadership and cross-functional collaboration skills, with the ability to influence and drive strategy across teams and with external partners and vendors Excellent analytical skills, including in-depth knowledge of COAs and pharmacoeconomic modeling and retrospective database analysis methodologies. Experience working with U.S. claims databases, EMRs, and patient registries; proficiency in RWE analytics platforms and methodologies. Knowledge of endocrine and/or obesity space a plus Ability to travel up to 20% 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 and Hawaii. 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.
Amylyx is a clinical-stage pharmaceutical company based in Cambridge, Massachusetts, with an audacious mission to develop novel therapies for high unmet needs. We are currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS). Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. 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. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and determination, we encourage you to read the opportunity below and apply. The Opportunity
The Senior Director, Health Economics And Outcomes Research (HEOR)/Real World Evidence (RWE) at Amylyx Pharmaceuticals will report to the SVP of Medical Affairs. This position will be an expert and experienced leader, engaging cross functionally to develop and drive HEOR and evidence generation strategies. The Senior Director will play an integral role in developing and communicating the value proposition for Amylyx' assets, including our lead program in post-bariatric hypoglycemia (PBH). This role will drive development of strategies, methods, and tools to ensure successful market access, adoption, and long-term impact in support of Amylyx' mission to find solutions for patients with high unmet needs. Responsibilities
Strategic Leadership Build and lead the HEOR function including the development of integrated HEOR and evidence generation strategies and tactical plans to support Amylyx's therapeutic programs Lead evidence gap analyses that will inform the HEOR strategic and tactical plans and lead cross-functional data generation and communication planning efforts to support health economic/value proposition and inform understanding of treatment patterns, disease burden, patient-reported outcomes, and unmet needs Evidence Generation & Study Execution Design and execute projects, such as burden of illness, real-world clinical outcomes, clinical registries, retrospective database analyses, and meta-analyses. Provide scientific support for protocol development, target product profiles, data collection strategies, literature review and evidence synthesis Stakeholder Engagement & Communication Oversee the development of peer-reviewed publications, conference presentations, and internal communication of HEOR findings. Support global market access strategy and plans for Amylyx pipeline products including, identifying opportunities for early scientific advice with key health technology assessment (HTA) agencies, regulatory support and preparing for global HTA models. Incorporate any recommendations into the clinical development program. Cross-Functional Collaboration Ensure all HEOR tactics are aligned cross-functionally with business strategies and regulatory guidelines. Monitor and interpret U.S. policy changes (e.g., IRA, CMS guidance) and translate implications into actionable HEOR strategies. Collaborate with Market Access and Medical Affairs to develop and maintain evidence packages tailored to U.S. payers, including commercial plans, Medicare, and Medicaid. Team & Vendor Management Lead vendor selection and manage external research partners to ensure high-quality and timely study delivery. Build and manage a team to support innovative real-world evidence generation and health economics research. Manage HEOR budget planning and resource allocation to ensure efficient execution of strategic priorities Required Qualifications
10+ years healthcare or pharmaceutical industry experience with minimum 7 in HEOR Master's Degree (MS, MPH, PharmD, PhD) in a relevant discipline (e.g., health economics, medicine, pharmacy, public health, epidemiology) required Demonstrated success in designing and leading real-world research to support US payer value and access. Experience supporting HEOR strategy for product launch, including pre-launch evidence generation and payer engagement, is highly desirable. Deep understanding of U.S. healthcare system dynamics, including payer structures, value-based care, and regulatory trends. Excellent leadership and cross-functional collaboration skills, with the ability to influence and drive strategy across teams and with external partners and vendors Excellent analytical skills, including in-depth knowledge of COAs and pharmacoeconomic modeling and retrospective database analysis methodologies. Experience working with U.S. claims databases, EMRs, and patient registries; proficiency in RWE analytics platforms and methodologies. Knowledge of endocrine and/or obesity space a plus Ability to travel up to 20% 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 and Hawaii. 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.