HEOR/RWE Senior/Director
Remote
Medical Affairs – Medical Affairs /
Full time/Exempt /
Remote
About Lykos Therapeutics
At Lykos Therapeutics, we are committed to making an impact on people’s lives. We envision a world where there are more tools available for the treatment of mental health and where conversations about mental health are destigmatized. We aspire to challenge the status quo through the development of novel therapies and therapeutic approaches to treat mental health conditions. Our initial focus is developing investigational MDMA-assisted therapy for adults living with PTSD. If approved by the FDA, MDMA-assisted therapy could be a potential new approach to treating PTSD, a condition that hasn’t had a new treatment option in decades.
MDMA-assisted therapy has been designated a Breakthrough Therapy by the FDA and the results of our two pivotal Phase 3 clinical trials were published in Nature Medicine. MDMA-assisted therapy has not been approved by any regulatory agency. The safety and efficacy of MDMA-assisted therapy have not been established for the treatment of PTSD.
Lykos is a public benefit corporation (PBC), with a dual mandate to generate shareholder value and public benefit. As a PBC, we consider the impact of our decisions on society just as we think about financial implications. We balance the interests of our many stakeholders including our employees, healthcare providers, therapists, investors and others. This means that we look through a public benefit lens with all that we do.
Why work for Lykos Therapeutics?
With 30+ years of experience researching psychedelic-assisted therapies, we remain committed to the rigorous pursuit of evidence-based development of novel approaches. We value impact, integrity, care, and openness and hold public benefit at the center of everything we do. We believe in diversity and inclusion of people of all backgrounds, genders, races, ethnicities, sexual orientations, educational backgrounds, arrest or conviction record, military and veteran status, religions, abilities, and perspectives and are committed to building a supportive, equitable, and accessible workplace.
Lykos has a distributed workforce that uses technology and periodic in-person gatherings to stay connected. We look for people who believe in our mission, are comfortable with and skilled at remote work and collaboration, and ready to step into a dynamic and fast-paced work environment.
HEOR/RWE Senior/Director Executive Summary
The Health Economics & Outcomes Research/Real-World Evidence (HEOR/RWE) Senior/Director is a strategic member of the Lykos Medical Affairs team, reporting to the VP of Medical Affairs. The HEOR/RWE Sr/Director will lead strategies for value evidence generation and outcomes research to support products from clinical development through post-launch life cycle management. Through partnership with members of the Medical Affairs and Commercial teams, the HEOR/RWE Sr/Director will identify evidence gaps, design strategies for data generation, and lead development of resources to support engagement with healthcare providers (HCPs), payor audiences and policy decision makers.
Key Responsibilities
- HEOR/RWE Strategy: Plan and execute strategies to demonstrate the clinical and economic value of Lykos products to HCP, payors and policymakers. Lead the development, management, and implementation of HEOR and RWE research to support pre- and post-launch product commercialization. Identify evidence generation needed to substantiate/sustain treatment with Lykos products in real-world settings.
- Tools and Research: Lead the design and development of comprehensive tools to support pricing and market access (e.g., value dossiers, cost effectiveness models, budget impact models, and publications). Design and lead prospective and retrospective research to generate real-world data surrounding disease burden, comparative treatment effectiveness, healthcare utilization, treatment patterns, and health outcomes. Define and execute data dissemination plans including technical reports, publications, value dossiers, and other deliverables.
- Collaboration and Oversight: Partner with Medical Affairs, Commercial, Regulatory, and Clinical teams to identify evidentiary requirements based on Lykos strategic goals and define subsequent HEOR and RWE plans. Develop effective relationships with key opinion leaders and decision makers both internally and externally. Develop and maintain knowledge of the most current disease state literature, health policy changes/trends, and methodologies for generating health economics and real-world evidence. Manage collaborations with external contractors/suppliers to achieve deliverables that are on time, to budget and in accordance with plan.
Minimum Requirements
- Master’s degree in Health Outcomes, Health Economics, Epidemiology, Pharmacy, or Health Sciences-related field; PharmD or PhD preferred.
- Minimum of 10 years in the pharmaceutical industry.
- Minimum 5+ years of HEOR/RWE experience in a Commercial, Medical Affairs, Scientific Affairs and/or R&D environment.
- Expert knowledge in RWE, epidemiology, HEOR, statistical and/or other quantitative methods and predictive modelling frameworks and techniques.
- Firm understanding of the uses of evidence-based medicine and comparative effectiveness analyses for health policy decision-making required.
- Strong ability to work in a remote environment.
- Demonstrated ability to influence in a matrixed organization.
- Experience in CNS preferred.
- Global experience including development of global value dossiers and economic models preferred.
Competitive benefit package includes:
Paid Time Off (PTO)
Sick Time
Holiday Pay
Medical, dental, vision, and life insurance
Employer funded mental health HRA
401k
FSA
Pet Insurance
Home Office Stipend
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
