compasspathways · East Coast, United States; Jersey City, New Jersey · Jersey City, New Jersey, United States
<div class="content-intro"><p><span style="font-size: 14pt;"><strong>Company introduction:</strong></span></p> <p><span data-ogsc="rgb(0, 0, 0)">Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care. </span></p> <p><span data-ogsc="rgb(0, 0, 0)">The Company is headquartered in London, UK, with a U.S. office in New Jersey. We believe mental health patients deserve the possibility of a better future. Our initial focus is developing COMP360 psilocybin, a proprietary, investigational, synthetic psilocybin treatment under evaluation for treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD). COMP360 is a potentially first-in-class treatment and has Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA), as well as Innovative Licensing and Access Pathway (ILAP) designation in the UK for TRD. </span></p> <p><span data-ogsc="rgb(0, 0, 0)">We are leading the world’s largest classic psychedelic clinical program in TRD, and building upon that robust foundation, we are executing a late-stage trial evaluating COMP360 for PTSD, another condition with high unmet need. Our goal is to advance treatments that move the field of psychiatry towards treatment options that offer rapid onset and sustained durability with infrequent dosing. -<span class="Apple-converted-space"> </span><a id="OWA7b9a9bdd-820c-52e3-19e0-7302f475ddce" class="x_OWAAutoLink" href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fcompasspathways.com%2F&data=05%7C02%7CAlexis.Rached%40compasspathways.com%7C81c31d1d5b344b36655308deebefbd0f%7Cb94a191dccb54154868e9dcbcb3e1412%7C0%7C0%7C639207612126678649%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=gtzmMKpxYEvhVQspKpFeeyQ6S%2Fq84f%2FpCwFrBs4C4Jc%3D&reserved=0" data-auth="NotApplicable" data-outlook-id="9c215bbc-5d45-4e9b-afdf-92d15cea8a68" data-ogsc=""><u>Compass Pathways</u></a></span></p></div><p><span style="font-size: 14pt;"><strong>Job overview</strong>:</span><strong> </strong></p> <p><span style="font-size: 12pt;">The Senior Manager, REMS & Specialty Pharmacy Operations will support the implementation, execution, and ongoing optimization of the REMS program and specialty pharmacy operational model for COMP360 in the United States. Partnering closely with the Senior Director, this role will help translate approved regulatory requirements and business objectives into compliant, scalable, and patient-centered operational processes.</span></p> <p><span style="font-size: 12pt;">This individual will oversee day-to-day REMS and specialty pharmacy operations, support vendor management and operational readiness activities, monitor program performance, and collaborate cross-functionally to ensure successful execution of approved REMS and distribution strategies. The ideal candidate brings experience in REMS, specialty pharmacy, patient services, or related pharmaceutical operations and thrives in a highly regulated environment.</span></p> <p><span style="font-size: 14pt;"><strong>Location:</strong></span> <span style="font-size: 12pt;">Remote on the East Coast, United States.</span></p> <p><span style="font-size: 14pt;"><strong>Reports to:</strong></span><strong> </strong><span style="font-size: 12pt;">Senior Director, REMS & Specialty Pharmacy Operations.</span></p> <p><span style="font-size: 14pt;"><strong>Roles and Responsibilities<br></strong><em>(include but not limited to)</em>: </span></p> <p><span style="font-size: 12pt;"><strong>REMS Operations</strong></span></p> <ul> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Support implementation and ongoing execution of REMS operational workflows, including site certification, user training, patient enrollment, treatment documentation, monitoring, and reporting</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Coordinate operational activities required to support REMS compliance and consistent execution across certified treatment sites and operational partners</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Maintain REMS process documentation, standard operating procedures, training materials, job aids, and operational workflows</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Monitor REMS performance metrics, reports, deviations, exceptions, and potential noncompliance indicators; coordinate intake, documentation, triage, and escalation in accordance with approved procedures</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Support audit and inspection readiness activities, including documentation management, operational simulations, and response preparation</span></li> </ul> <p><span style="font-size: 12pt;"><strong>Specialty Pharmacy Operations</strong></span></p> <ul> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Support implementation and ongoing management of specialty pharmacy operational workflows and distribution processes</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Coordinate onboarding, training, and operational readiness activit