CP

COMPASS Pathways

2 open positions available

1 location
1 employment type
Actively hiring
Full-time

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Senior Manager, REMS and Specialty Pharmacy Operations

COMPASS Pathways•Anywhere•Full-time
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Compensation$160K - 190K a year

You would support REMS and specialty-pharmacy workflows, vendor performance, compliance readiness, operational reporting, and launch improvements. | The role seeks 5–8 years in pharmaceutical or related healthcare operations, including at least 2 years supporting REMS, specialty pharmacy, patient services, or comparable regulated programs. | Company introduction: 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 Job overview: 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. Location: Remote on the East Coast, United States. Reports to: 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 • Support audit and inspection readiness activities, including documentation management, operational simulations, and response preparation Specialty Pharmacy Operations • Support implementation and ongoing management of specialty pharmacy operational workflows and distribution processes • Coordinate onboarding, training, and operational readiness activities for specialty pharmacy partners • Monitor specialty pharmacy performance metrics, service levels, turnaround times, and operational compliance indicators • Partner with specialty pharmacy stakeholders to identify, troubleshoot, and resolve operational issues affecting treatment sites, healthcare providers, or patients • Support execution of distribution-related process improvements and operational initiatives Vendor Management • Serve as a primary day-to-day operational contact for the REMS Administrator, REMS operational vendors, and specialty pharmacy partners • Track vendor deliverables, action items, performance metrics, service-level commitments, risks, and dependencies • Support recurring business reviews and operational governance meetings with vendor partners • Coordinate follow-up and resolution of vendor-related issues and escalate operational risks, compliance concerns, or unresolved matters to appropriate stakeholders and leadership • Partner with Quality on vendor qualification, quality agreements, and supplier quality oversight activities, as applicable Cross-Functional Collaboration • Partner with Regulatory Affairs, Quality, Pharmacovigilance, Compliance, Medical Affairs, Patient Engagement, Market Access, Trade & Distribution, and Commercial teams to support operational execution • Translate approved REMS requirements into executable workflows while maintaining alignment with established functional ownership, governance, and escalation pathways • Coordinate cross-functional activities required to support launch readiness, ongoing program operations, and operational enhancements • Participate in governance forums and provide updates on operational performance, risks, dependencies, and mitigation plans • Support change management activities resulting from regulatory updates, process improvements, vendor changes, or evolving business needs Launch Readiness and Continuous Improvement • Support launch readiness planning and execution, including operational testing, training deployment, simulation exercises, process validation, and readiness assessments • Analyze operational data and stakeholder feedback to identify trends, process constraints, and improvement opportunities • Develop routine operational reports and dashboards to support performance monitoring and decision-making • Facilitate cross-functional review of trends, coordinate approved improvements, and track implementation of corrective or preventive actions • Contribute to scalable processes that support compliant operations and an effective treatment site and patient experience Candidate Profile: 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 Preferred Qualifications • Advanced degree such as an MBA, MPH, PharmD, MS, or equivalent preferred • Experience supporting product launch, launch readiness, or commercialization activities • Experience developing or maintaining SOPs, training materials, operational workflows, and process documentation • Knowledge of pharmaceutical compliance requirements and healthcare operational processes Knowledge & Skills • Working knowledge of FDA REMS programs and associated operational requirements • Understanding of specialty pharmacy, patient access, and limited distribution workflows • Strong project management, organizational, and prioritization skills, with the ability to manage multiple priorities and dependencies in a fast-paced environment • Strong analytical, problem-solving, and issue-resolution skills • Experience tracking metrics and developing operational reports • Excellent written and verbal communication skills • Proficiency with Microsoft Office applications and operational reporting tools Compensation Description (annually): 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 Benefits: For an overview of our benefits package and compensation information, please visit "Joins us - Our Benefits". These include flexibility & generous time off, parental & reproductive support, health & medical, mental health & wellbeing and Financial health. Equal opportunities: Reasonable accommodation 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 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. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: 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.

Vendor management and SLA governance
Operational metrics and process improvement
Cross-functional team leadership
Workflow documentation and change management
Verified Source
Posted 17 days ago
Compass Pathways

Associate Director, Scientific Communications

Compass Pathways•Anywhere•Full-time
View Job
Compensation$160K - 220K a year

Lead scientific communications strategy, publication planning, and congress activities, translating clinical data into content that supports medical affairs and launch readiness. | Requires an advanced scientific degree such as an MD, PharmD, or PhD and at least eight years of medical-affairs or scientific-communications experience, including biopharmaceutical publication planning and writing. | Company introduction: 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 Job overview: The Associate Director, Scientific Communications will help to optimize and execute the Scientific Communications function within Medical Affairs, stewarding the capabilities, processes, and scientific communications that support launch readiness and future growth. This individual will translate emerging clinical and scientific evidence into clear, compelling, and scientifically rigorous communications that advance Medical Affairs strategy and scientific exchange. Success in this role requires equal parts strategic thinking and hands-on execution. Working closely with the Executive Director of Medical Affairs, the Associate Director will help shape scientific communications strategy while personally owning key deliverables, including publications, congress materials, scientific platforms, slide decks, FAQs, and medical education resources. The role requires a balance of strategic thinking and practical execution, partnering across Medical Affairs, Clinical Development, HEOR, Regulatory, Legal, Compliance, and Field Medical to continuously improve publication planning, congress planning, and scientific communications processes that enable timely, consistent, and impactful dissemination of scientific evidence. We are seeking a scientifically rigorous, intellectually curious, and creative team player who is energized by the opportunity to build something new. The ideal candidate enjoys solving complex challenges, values diverse perspectives, and combines scientific excellence with thoughtful design to create engaging, high-impact scientific communications that ultimately improve patient care. Location: Remote in the United States. Reports to: Executive Director, Medical Affairs. Roles and responsibilities (Includes but not limited to): Stewardship of the Scientific Communications Function Drive the defined Scientific Communications plans within Medical Affairs, contributing to scalable processes and capabilities to support launch and long-term growth Partner with Medical Affairs leadership to develop and execute an integrated Scientific Communications strategy aligned with organizational priorities Identify opportunities to improve how scientific information is communicated by introducing thoughtful, innovative approaches that enhance clarity, quality, and impact Vendor selection and management, and engagement with external thought leader collaborators Publications Planning and Scientific Dissemination Lead publication planning and execution across the Medical Affairs portfolio, ensuring timely and effective dissemination of scientific evidence Refine and continuously improve publication planning processes, governance, and execution in collaboration with cross-functional stakeholders Partner with internal subject matter experts, Clinical Development, and external authors to develop manuscripts, abstracts, posters, and oral presentations in accordance with compliance policies Monitor publication timelines and proactively identify risks, opportunities, and dependencies Congress Scientific Planning and Execution Lead scientific planning for key medical congresses in partnership with cross-functional teams Coordinate congress scientific communications with publication plans and organizational priorities Support the development of abstracts, posters, presentations, and related scientific content Ensure congress activities maximize scientific engagement and effective dissemination of new evidence High-Impact Scientific Communications Collaborate closely with the Field Medical organization to develop high-quality scientific communications that support scientific exchange Develop and maintain scientific slide decks, FAQs, educational resources, advisory board materials, presentations, and other Medical Affairs communications Translate complex scientific and clinical data into accurate, engaging communications tailored to diverse scientific audiences Ensure scientific consistency across Medical Affairs communications through thoughtful review and content stewardship Scientific Communication Platforms Own and continuously evolve the Treatment-Resistant Depression Scientific Communications Platform as the scientific foundation for Medical Affairs communications Partner with internal scientific leaders to develop and maintain the PTSD Scientific Communications Platform Ensure emerging scientific evidence is appropriately integrated into communication platforms and core Medical Affairs materials Candidate Profile: Advanced scientific degree (PharmD, PhD, MD, DO, PsyD, or equivalent) in a relevant scientific discipline Minimum 8 years experience in Medical Affairs, Scientific Communications, Publications, or a related function within the biopharmaceutical industry and/or scientific/medical communications agency Demonstrated experience leading publication planning and execution, including manuscripts, abstracts, posters, and scientific presentations Experience supporting scientific communications for major medical congresses Exceptional scientific writing, editing, and communication skills, with the ability to translate complex data into clear and compelling scientific communications Prior leadership experience in Scientific Communications is strongly preferred with demonstrated success managing multiple priorities in a fast-paced environment Experience in psychiatry, neuroscience, or other CNS therapeutic areas strongly preferred Launch or pre-commercial experience is highly desirable Intellectually curious and enjoys solving complex scientific and operational challenges Highly collaborative, seeking diverse perspectives, while maintaining the confidence to make decisions and move work forward Compensation Description (annually): 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】: $210,000—$255,000 USD Benefits: For an overview of our benefits package and compensation information, please visit "Joins us - Our Benefits". These include flexibility & generous time off, parental & reproductive support, health & medical, mental health & wellbeing and Financial health. Equal opportunities: Reasonable accommodation 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 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. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: 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.

Scientific writing and communications
Publication planning
Clinical data translation
Cross-functional project leadership
Regulatory compliance
Direct Apply
Posted 23 days ago

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