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Senior / Manager, Medical Review

Lykos Therapeutics

Lykos Therapeutics

Remote
Posted on Saturday, February 3, 2024
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.
Senior/Manager, Medical Review Summary:
The Senior/Manager, Medical Review is an integral member of the Medical Affairs team, reporting into the Senior Director, Medical Education, Communications & Review. The Senior/Manager will partner with Legal and Regulatory counterparts, serving on the Promotional Materials Review and Medical Review Committees (PMRC/MRC). This role will help establish and maintain standards to ensure materials are accurate, not misleading, balanced, and supported by scientific evidence.

Key Responsibilities:

  • Medical Reviewer on PMRC: Serve as the primary Medical reviewer and approver for promotional and corporate materials intended for internal or external audiences. Review promotional materials to ensure presentation of promotional claims reflect strengths and weaknesses of supporting data, medical accuracy, and clinical relevance of study methodology. Provide medical guidance on sales training and promotional materials advertised through broadcast, digital media or print, including but not limited to presentations, sales aids, direct to consumer advertisements, reminder advertisements and websites. Maintain strong knowledge of and monitor changes to FDA regulations and guidance surrounding prescription drug advertising and promotion.
  • Medical Reviewer on MRC: Serve as the primary Medical reviewer and approver for scientific materials intended for internal or external audiences. Review materials to ensure they are unbiased, scientifically accurate, and substantiated by strong evidence, including but not limited to standard response letters, presentations, publications and scientific exchange resources. Review materials against clinical data and/or approved labelling to verify accuracy and appropriateness of references and data on file citations.
  • Literature Surveillance: Maintains a comprehensive understanding of disease state concepts and scientific data in order to develop high-quality programs and relevant materials. Monitors new literature on a continuous basis, maintaining broad knowledge of assigned therapeutics areas, product labelling and regulatory guidance.

Minimum Requirements:

  • Bachelor’s Degree; advanced degree (PharmD, PhD, MD, PA, NP, RN) preferred.
  • At least 3 years of direct promotional/medical review experience and be comfortable working independently in a fully remote role with minimal oversight.
  • Demonstrated ability to critically analyze research design, methods, and outcome measures.
  • Ability to work effectively and collaboratively in a virtual work environment.
  • Excellent oral and written communication skills.
  • Advanced knowledge of pharmaceutical guidelines and regulations.
  • Experience with Veeva Vault PromoMats strongly 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.