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East Coast, United States; Jersey City, New Jersey
Source: Compass Pathways careers · View original posting
From Compass Pathways's posting. “We” and “our” refer to the employer.
Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care.
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.
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. -
Compass Pathways
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.
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.
Hybrid in our Jersey City office or remote in the East Coast, United States.
Senior Director, REMS & Specialty Pharmacy Operations.
Roles and Responsibilities
(include but not limited to):
REMS Operations
Support implementation and ongoing execution of REMS operational workflows, including site certification, user training, patient enrollment, treatment documentation, monitoring, and reporting
Coordinate operational activities required to support REMS compliance and consistent execution across certified treatment sites and operational partners
Maintain REMS process documentation, standard operating procedures, training materials, job aids, and operational workflows
Monitor REMS performance metrics, reports, deviations, exceptions, and potential noncompliance indicators; coordinate intake, documentation, triage, and escalation in accordance with approved procedures
Partner with Regulatory Affairs, Quality, Pharmacovigilance, Compliance, Medical Affairs, Patient Engagement, Market Access, Trade & Distribution, and Commercial teams to support operational execution
Experience
5-8 years of experience in pharmaceutical, biotechnology, specialty pharmacy, healthcare services, patient support services, market access, or a related healthcare industry
At least 2 years of experience supporting REMS programs, specialty pharmacy operations, patient services, access operations, trade and distribution operations, or other regulated healthcare programs
Experience managing operational projects and coordinating cross-functional stakeholders
Experience working with external vendors, service providers, specialty pharmacies, or healthcare partners
Compensation
Our compensation package for permanent hires includes base salary, discretionary bonus, and equity, alongside our comprehensive benefits offering.
Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.
【Base salary per annum】:
$160,000 — $190,000 USD
We are committed to building a workplace where everyone’s wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know.
UK applicants
We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability.
US applicants
Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying.
All data is confidential and protected by all legal and data privacy requirements, please see our recruitment
Privacy Notice to learn more about how we process personal data.
Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law.
LAYIQ is an independent job-discovery service. This listing does not imply a partnership with or endorsement by the employer. Review the original posting for current details and availability.
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