REMS Senior/Manager
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.
REMS Manager Executive Summary
As a member of the Medical Affairs department, the REMS Manager will provide support for the Risk Evaluation and Mitigation Strategy (REMS) program for MDMA-assisted therapy. This role will report to the Director of Operations for Medical Affairs. The REMS manager will manage the development and ongoing administration of the REMS program, working with the contracted REMS program vendor to ensure the final MDMA-assisted therapy REMS program enables efficient, compliant and seamless enrollment for all stakeholders. The REMS Manager will also be responsible for:
- Coordination and management of all related REMS materials
- Support of REMS-related FDA information requests (IRs) pre-approval
- Management of all related REMS team meetings for internal Lykos teams and external REMS administrator vendor
Key Responsibilities
- Program Management: Manage REMS contractor vendors, work orders, and budgets. Ensure all REMS vendor contracts are in good standing and in place prior to work commencing or continuing and obtain necessary reviews and approvals from internal stakeholders. Ensure implementation of necessary modifications to all REMS materials throughout the FDA review.
- Program Administration: Coordinate and manage all REMS meetings with internal stakeholders and REMS vendor including agenda development, compilation and distribution of meeting minutes, management of timelines, and completion of action items. Support presentation development, reporting on key data, analytics, and processes to senior leadership.
- Compliance: Develop and manage REMS Non-Compliance Review Committee (NCRC), including governing documents, non-compliance issue reviews, and documentation and communication of Committee meetings and decisions.
- Program Documentation Ownership: Manage and route all required REMS documents, materials(post-approval) and associated change control requests to internal stakeholders, as required.
- Support daily REMS functions as required to meet business and regulatory requirements, including audit plan compliance and REMS assessment reports to FDA.
Minimum Requirements
- Bachelor's degree (or equivalent) in relevant field
- A minimum of 4-6 years of experience in the pharmaceutical industry, with 2-3 years of experience in REMS development and administration
- Knowledge of healthcare regulations
- Ability to critically assess website content and user-interfaces with an emphasis on usability and target audience
- Excellent oral and written communication skills
- Fluent in English (oral and writing)
- Strong proficiency in Microsoft Office suite, Veeva Quality Docs and Veeva QMS Vaults
- Ability to work effectively and collaboratively in a virtual work environment
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.
