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• Job Type: Officer of Administration, • Bargaining Unit:, • Regular/Temporary: Regular, • End Date if Temporary:, • Hours Per Week: 35, • Standard Work Schedule:, • Building: Reporting directly to the Associate Director of Regulatory Science (the "Associate Director") of the Clinical Trials Office (the "CTO") of Columbia University's Vagelos College of Physicians & Surgeons ("P&S") at Columbia University Irving Medical Center ("CUIMC"), the Regulatory Science Specialist assists the Associate Director in overseeing the CTO's regulatory compliance and providing assistance to the research community in the development and conduct of clinical trials. The CTO, which is operated jointly with the New York-Presbyterian Hospital ("NYPH") assists investigators and academic/research staff in developing clinical trials at CUIMC and provides administrative resources and infrastructure to build and sustain clinical trials research. Responsibilities The Regulatory Science Specialist is responsible for the following: • Collaborates with the Associate Director, the Executive Director of the CTO (the "Director"), the Medical Director of the CTO, CUIMC faculty and administration and NYPH administration in meeting the institutional needs regarding clinical trial compliance, quality assurance, training and process-improvement goals., • Assists the Associate Director in developing and implementing policies and procedures designed to assure that clinical trials are carried out in compliance with applicable federal and state regulations, including those promulgated in the U.S. Food and Drug Administration, the U.S. Department of Health and Human Services, the Centers for Medicare and Medicaid Services and the rules of the Joint Commission., • Assists the Medical Director and Associate Director of Regulatory Science in implementing the IND/IDE Assistance Program, which provides regulatory guidance in connection with investigator initiated clinical trials., • Assists in the implementation of a training program for research personnel, including research newsletters, workshops, and didactic training sessions upon request., • Provides guidance regarding regulatory and institutional requirements to investigators and research personnel, • Participates in the Clinical Trials Monitoring Assistance Program (CTMAP) that includes oversight and monitoring of investigator/coordinator compliance with standard operating procedures as they pertain to the conduct of FDA regulated clinical trials., • Collaborates with the CTSA and the HRPO/IRB in developing programs such as programs to increase patient recruitment and to address regulatory and compliance needs., • Provides support of RecruitMe Platform for the CUIMC research community including:, • Coordinating with investigators and research teams in RecruitMe entry., • Developing training and process improvement projects, and other project management duties with RecruitMe., • Collaborating with the Director and Associate Director to implement objectives and workflow strategies for content maintenance on RecruitMe and other CTO websites., • Fulfilling reporting requirements for management, including metrics from Google Analytics data., • Monitoring external communications for social media websites., • Liaising with RecruitMe contacts, information technology ("IT") groups, CTSA leadership, outside vendors and/or internal partners in research for needs related to RecruitMe and other CTO websites., • Represents the Manager and Director in his/her absence and all other duties as assigned. Minimum Qualifications • Bachelor's degree, • In depth knowledge of federal, state and local laws and regulations and industry requirements and practices regarding the proper conduct of clinical trials:, • Particular knowledge and experience in FDA matters, including regulations relating to INDs and IDEs, • Expert working knowledge in GCP, patient safety standards and IRB regulations pertinent to clinical research, • Demonstrable ability to collaborate with partners in research, investigators and coordinators, • Excellent verbal and written communication skills, • Excellent interpersonal and presentation skills, • Strong computer skills required, including proficiency with content management systems, social media websites, Microsoft Office, • Ability to manage/handle multiple tasks, teams, and teamwork simultaneously. Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents.

The Eleanor and Lou Gehrig ALS Center of Columbia University invites applications for a full-time faculty position for a neurologist with expertise in amyotrophic lateral sclerosis (ALS) to serve as the Director of Clinical Trials. The successful candidate will join a multidisciplinary team dedicated to excellence in ALS patient care, research, and education. As Director of Clinical Trials, the candidate will play a key leadership role in developing, overseeing, and expanding the clinical trials portfolio focused on ALS and related motor neuron diseases. Key Responsibilities: • Lead and manage all clinical trial activities related to ALS within the ALS Center, including industry-sponsored, investigator-initiated, and NIH-funded studies., • Develop and expand our high-impact ALS clinical and translational research programs, fostering innovation and collaborations across departments and with external partners., • Oversee protocol development, study design, IRB submissions, regulatory compliance, budgeting, and monitoring., • Serve as Principal Investigator (PI) or Co-PI on clinical trials, ensuring scientific integrity, regulatory compliance, and patient safety., • Collaborate with basic science and translational research teams to align clinical trials with emerging therapeutic targets and biomarkers., • Mentor and supervise clinical research staff, fellows, and junior faculty involved in ALS research., • Participate in the evaluation, diagnosis, and clinical care of ALS patients within a multidisciplinary team setting., • Present findings at national and international conferences and publish in peer-reviewed journals., • Contribute to grant writing and fundraising activities to support clinical research infrastructure and innovation., • MD or DO degree with board certification in Neurology., • Completion of a Neuromuscular and/or ALS Fellowship strongly preferred., • Proven track record in ALS clinical research, including experience in conducting or overseeing clinical trials., • Eligibility for medical licensure in the state of New York., • Academic qualifications for a faculty appointment at the Assistant, Associate, or Full Professor level., • Strong leadership, organizational, and communication skills., • Experience as a Principal Investigator on multi-center clinical trials., • Involvement in national ALS research networks such as NEALS, CReATe, or ALS Association consortia. Pay Transparency Disclosure The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

The Eleanor and Lou Gehrig ALS Center of Columbia University invites applications for a full-time faculty position for a neurologist with expertise in amyotrophic lateral sclerosis (ALS) to serve as the Director of Clinical Trials. The successful candidate will join a multidisciplinary team dedicated to excellence in ALS patient care, research, and education. As Director of Clinical Trials, the candidate will play a key leadership role in developing, overseeing, and expanding the clinical trials portfolio focused on ALS and related motor neuron diseases. Key Responsibilities: • Lead and manage all clinical trial activities related to ALS within the ALS Center, including industry-sponsored, investigator-initiated, and NIH-funded studies., • Develop and expand our high-impact ALS clinical and translational research programs, fostering innovation and collaborations across departments and with external partners., • Oversee protocol development, study design, IRB submissions, regulatory compliance, budgeting, and monitoring., • Serve as Principal Investigator (PI) or Co-PI on clinical trials, ensuring scientific integrity, regulatory compliance, and patient safety., • Collaborate with basic science and translational research teams to align clinical trials with emerging therapeutic targets and biomarkers., • Mentor and supervise clinical research staff, fellows, and junior faculty involved in ALS research., • Participate in the evaluation, diagnosis, and clinical care of ALS patients within a multidisciplinary team setting., • Present findings at national and international conferences and publish in peer-reviewed journals., • Contribute to grant writing and fundraising activities to support clinical research infrastructure and innovation., • MD or DO degree with board certification in Neurology., • Completion of a Neuromuscular and/or ALS Fellowship strongly preferred., • Proven track record in ALS clinical research, including experience in conducting or overseeing clinical trials., • Eligibility for medical licensure in the state of New York., • Academic qualifications for a faculty appointment at the Assistant, Associate, or Full Professor level., • Strong leadership, organizational, and communication skills., • Experience as a Principal Investigator on multi-center clinical trials., • Involvement in national ALS research networks such as NEALS, CReATe, or ALS Association consortia. Pay Transparency Disclosure The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

• Job Type: Officer of Administration, • Regular/Temporary: Regular, • Hours Per Week: 35 Reporting directly to the Associate Director of Regulatory Science (the " Associate Director") of the Clinical Trials Office (the "CTO") of Columbia University's Vagelos College of Physicians & Surgeons ("VP&S") at Columbia University Irving Medical Center ("CUIMC"), the Recruitment Application Specialist assists the Associate Director in overseeing CTO's clinical research subject recruitment application ("RecruitMe") and other research applications. The clinical research subject recruitment application is a collaboration between the CTO and the Irving Institute for Clinical and Translational Research (the "CTSA"). The CTO assists investigators and academic/research staff in developing clinical trials at VP&S and provides administrative resources and infrastructure to build and sustain clinical trials research at VP&S. The Irving Institute for Clinical and Translation Research works to foster a multi-disciplinary scientific mindset to encourage collaboration between disciplines. The successful candidate will work with Investigators and the research team in providing essential support of RecruitMe and the CTO. Responsibilities The Recruitment Application Specialist is responsible for the following: • Working with the Associate Director, implements objectives and workflow strategies for keeping RecruitMe and other CTO websites and applications up to date and refreshed, ensuring that all content is effectively incorporated across websites of the CTO., • Leads and coordinates with Investigators and research teams in the gathering, documenting and managing of required documents for entering into RecruitMe and performing routine maintenance duties, including content revisions and updates., • Interprets clinical trial and protocol information and provide accurate summarizations., • Manages the training, maintenance and support of RecruitMe to the CUIMC clinical trials research community., • Creates, manages, and monitors external communications for social media websites and perform regular audits of social media content and related advertising., • Leads program for training and process improvement projects, and other project management duties with RecruitMe and other applications., • Performing regular audits of site content and users for timeliness, accuracy, style, and branding., • Assists the Investigators and research teams to implement revisions, as necessary., • Provides design element knowledge to RecruitMe and other applications for better end-user use., • Has ability to learn applications rapidly and disseminating applicable learnings to user base., • Generates reports for management, including metrics from system data, including Piwik Pro., • Provides project management for RecruitMe and related research applications and providing research team support and service., • Liaises with RecruitMe contacts to maintain on-going delivery of documentation for entering trials into system and coordination with data entry specialists., • Liaises with different information technology ("IT") groups such as CUIMC IT and/or outside vendors to resolve technical problems as the situation requires., • Liaises with internal partners in research such as Sponsored Projects Administration, the Institutional Review Boards (the "IRB") and the Irving Institute for Clinical and Translational Science. Bachelor's Degree or equivalent in education and experience and a minimum of 4 years of related experience required. * Additional Position-Specific Minimum Qualifications: • The candidate must be able to work independently with prior project management experience., • Demonstrate ability to collaborate with partners in research, Investigators and research teams., • Demonstrate an ability to understand clinical research and summarize research news and protocols in lay terms., • Excellent verbal, written and editorial communication skills with an attention to detail required., • Excellent interpersonal and presentation skills., • Ability to manage/handle multiple tasks, teams, and teamwork simultaneously. Columbia University is committed to the hiring of qualified local residents.

We are currently seeking a full-time Associate in Rehabilitation and Regenerative Medicine and Research Physical Therapist for the Programs in Physical Therapy, Department of Rehabilitation and Regenerative Medicine, at Columbia University Irving Medical Center. The primary role of the physical therapist will be to provide assessment and treatment to research patients while also expanding the research-related activities. The candidate should be highly motivated, interested in pediatric neuromuscular disease, have excellent clinical skills, and have an interest in academic research. We are seeking an individual who can establish a strong rapport with children, their families, and the interprofessional healthcare team. The candidate should possess strong assessment skills and be well-versed in the application of evidence-based practice. Effective writing and communication skills are essential. Computer skills are required, including proficiency with Microsoft Word, Excel, Outlook, and PowerPoint. This position requires a special individual who can perform well in both clinical practice and an academic research environment. Responsibilities include: • Clinical trial evaluation, spirometry testing, motor function testing, quantitative muscle testing and other clinical and research evaluations of neuromuscular and neurodevelopmental disorders patients, • Data collection and entry, scheduling, and preparation for study visits, • Monitoring adherence to regulatory requirements and good clinical practice, • Assist the investigators in the design, planning, and implementation of new research projects, • Assist in writing protocols, • Assist in maintaining research files, • Assist with teaching the Pediatric Doctor of Physical Therapy Coursework, • Assist with student advisement on Pediatric Research Practicum Projects, • Provide clinical services to pediatric patients in the Programs in Physical Therapy Faculty practice as needed. Minimum Requirements: • Physical Therapy License in New York State, • Terminal degree preferred (EdD, PhD), currently enrolled will be considered, • Effective writing and communication skills are essential, • Computer skills are required, including proficiency with Microsoft Word, Excel, Outlook, and PowerPoint Preferred Requirements: • Ability to work in teams, flexibility, and a positive attitude, • Experience with neuromuscular disease/SMA is helpful but not required Pay Transparency Disclosure The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

The Associate Director, Medical Science Liaison – Respiratory serves as a scientific expert in the field and an extension of the Medical Affairs organization. Strong understanding of the Medical Science Liaison function, clinical trial design, evidence generation, and US Medical Affairs principles

Job Description (Associate) Director, Clinical Scientist (Remote) Key Responsibilities • Provide scientific and strategic leadership in the planning and execution of clinical trials, including protocol development, study design, and data analysis., • Author and review clinical protocols, ICFs, CSRs and regulatory documents, • Collaborate closely with cross-functional teams, including Clinical Operations, Regulatory Affairs, Biostatistics, and Medical Affairs, to ensure the successful conduct of clinical studies., • Interpret clinical data, prepare study reports, and contribute to regulatory submissions and presentations for internal and external stakeholders., • Support investigator meetings, advisory boards and data monitoring committee meetings, • Stay current with emerging scientific literature, competitive landscape, and regulatory requirements relevant to Immuneering’s oncology therapeutic area., • Support the development of clinical development plans and contribute to the strategic direction of ongoing and future programs., • Work closely with CRO’s and have a can do, proactive biotech mindset. Qualifications & Education · PhD, PharmD, RN, or MD in a relevant scientific discipline (e.g., biology, pharmacology, medicine). · Minimum of 5-8 years of experience in clinical development within the pharmaceutical or biotechnology industry. · Direct Phase 3 oncology clinical trial experience required. · Demonstrate experience authoring and reviewing clinical documents. · Demonstrated strong experience in clinical trial execution and data interpretation. · Strong analytical, organizational, and communication skills. · Deep understanding of oncology clinical development, endpoints and regulatory expectations. Technical / Soft Skills · Excellent cross-functional communication and stakeholder management. · Ability to work collaboratively in a fast-paced, team-oriented environment. · Must be a strong champion of our Values: All in, Data Rules, Care, Humble, Own It (Accountable) Physical Demands/ Working Conditions The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires the ability to perform essential job functions with or without reasonable accommodation. No significant lifting is associated with the role. While extensive travel is not anticipated with this role, it is possible to perhaps up to 15% at times. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role. Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission. Job Offers: Immuneering uses the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam. Note to Recruitment Agencies: We appreciate your interest in finding talent for Immuneering but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Immuneering without a prior written agreement in place will be considered property of Immuneering, and no fee will be paid in the event of a hire. Thank you for your understanding.

Job Description Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job overview: Joining a small but highly effective Clinical Data Management team to support leading and overseeing all data management activities for clinical studies from study start-up to database lock in compliance with departmental SOPs and regulatory guidelines. The Associate Director, Clinical Data Management will represent Compass Data Management in the USA, providing additional time zone coverage for international trials and acting as the Data Management SME in the US for Compass team members, external vendors and regulatory interactions. Under the direction of the UK head of Clinical Data Management, the Associate Director, Clinical Data Management is responsible for executing, overseeing, and synchronizing the following activities: leading and coordinating initiatives to evaluate and implement efficiencies, protocol review, CRF design and development, development of database specifications, development of edit check specifications, development of the Data Management Plan, development of CRF Completion Guidelines, User Acceptance Testing (UAT), data review, query generation and resolution, data reconciliation, identification and review of protocol deviations, review of adverse events, and maintenance of study documentation in the electronic Trial Master File (eTMF). Location: Hybrid in our New York City office or remote in the East Coast. Reports to: Director, Clinical Data Management. Roles and responsibilities (Include but are not limited to): • Contribute or lead development of process initiatives including, DM SOPs, Work Instructions, best practice standards (including data collection standards and implementation of advanced data review technology (e.g. analytic reviews, implementation of AI), • Accountable and responsible for ensuring the delivery of high-quality data management deliverables and activities from protocol review through database closure and archiving, • Lead design of high-quality EDC CRFs in consultation with cross functional partners that align to the data collection requirements identified in the study protocol, align with internal standards, and accurately reflect study endpoints, • Lead the development of data set-up integration needs for eCOAs, ePROs, eConsent and other data collection technologies as required by the protocol, • Maintain complete and accurate records of study data, reports, and documentation and files in the eTMF as appropriate to ensure compliance with departmental SOPs and all regulatory guidelines, • Perform, and/or oversee the complete and accurate review and processing of clinical trial data, including identification, resolution, and clarification of any missing, inconsistent, or clinically questionable data by the study team and/or sites, • Identify and implement the most appropriate study data management study status/KPIs; analytic checks, data integrity checks and reports to ensure data integrity across Compass portfolio, • Lead data management function in ongoing study CRO vendor selection, qualification, evaluation and oversight, • Author, review, and/or approve data management study documents (e.g., eCRF specifications, annotated CRFs Edit Check specifications, eCRF completion Guidelines, Data Transfer Plans, etc.) and ensure documents are maintained and ready for regulatory inspection, • Support or lead data management function for submissions, audits and regulatory inspections as required, • Leverage project management skills to support and oversee multiple projects outsourced and work in a cross-functional team environment, • May include line management of data management reports, • Bachelor's degree in life sciences, health sciences, or computer sciences field or equivalent combination of education, training, and industry related experience, • A minimum of seven (7) years of clinical data management experience in the pharmaceutical or Clinical Research Organization setting, • Proven track record of strong project management skills and experience managing data management activities, • Experience in vendor selection, partnering, and management, • Expert understanding of clinical data lifecycle, including database design, data structure, database development and testing, query management, data quality review, and database lock procedures, • Late stage development (Phase III) and NDA experience are preferred, • Advanced working knowledge of data collection standards including CDISC, CDASH and experience with medical coding dictionaries (MedDRA and WHODrug), • Expert knowledge of 21 CFR Part 11 regulations and regulatory submission requirements, • Expert knowledge of clinical data collection systems including EDC, eCOA and other data collection technologies, • Excellent written and verbal communication skills 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 pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】:$160,000—$200,000 USDBenefits & Compensation: For an overview of our benefits package and compensation information, please visit "Working at Compass". 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.

Job DescriptionRole Summary The Clinical Supply (Senior) Manager/Associate Director supports the cross-functional working team and independently plans and organizes tasks to meet specified objectives and timelines. This role manages supply planning and delivery of development products to clinic by supporting clinical supply inventory management, clinical supply packaging, labelling, interactive web response system (IWRS), distribution, and logistics planning. The Clinical Supply (Senior) Manager/Associate Director is responsible for clinical supply budget and tracking in addition to managing and executing the clinical supply chain for current and future clinical study programs at all development levels. This individual contributor role has a strong focus on late-stage program development and commercial launch readiness. The Clinical Supply (Senior) Manager/Associate Director also has oversight of vendors supporting Clinical Development Manufacturing Organization (CDMO), Secondary Packaging and Distribution, Comparator Sourcing. Primary Responsibilities • Own the coordination and execution of all clinical supply-related activities including supply planning, cGMP secondary packaging/labelling, distribution, and logistics for clinical programs, • Support IWRS User specifications and UATs, • Execute clinical supply chain sourcing strategy utilizing 3rd party providers in coordination with clinical operations current and future programs, • Manage supplier relationships with vendors including maintaining key performance metrics and budget/invoice tracking, review supply needs for study start-up, ongoing resupply strategies, contract negotiation, amendments and closeout requirements, • Evaluate vendor selection to support clinical study supply chain according to capability and fit, • Generate RFPs for vendor proposals with the ability to breakdown study protocols to support the supply strategy and communicate study needs to obtain vendor based budgeting or internal support, • Contribute program budget review and invoicing considerations as it relates clinical supply chain study management and capture any impacts, • Support the clinical program’s global supply chain in current and future clinical studies for clinical supply to commercial strategy. Oversee international depots and distribution as appropriate, • Support governance committees for global clinical operations and global clinical supply chain, • Ensure consistency across processes and develop tools to implement sustainable improvements, • Manage the execution of clinical supply strategy for specific clinical programs from early to late stage development with an understanding of commercial launch readiness, • Understand the roles and responsibilities of all functions represented on cross functional drug development teams to mitigate up and downstream operational deliverables., • Support regulatory filings including IND and BLA submission information as it relates to a global supply chain, • Provide regular updates to the TMF as per departmental requirements that comply with all regulatory requirements., • Participate in clinical study team meetings, align with study details, collaborate in meeting study objectives, and provide supporting information to the teams (includes RA, RACMC, Clinical Operations, Manufacturing and Development), • Additional responsibilities as needed Required Skills and Qualifications, • Bachelor's degree in life sciences, business-related field, or supply chain management; Master’s degree in Supply Chain Management preferred, • Minimum 5 years of experience handling/leading clinical supply chain and logistics; development experience preferred; 10+ years experience (7 years experience with Master’s degree) for Associate Director level, • Experience with clinical supply pack/label/distribution, clinical trial operations, project management, pharma/bio research and development, and inventory management strongly preferred, • Knowledge of clinical materials production processes and design strategy for patient dose kits supporting a clinical study design, • Ability to rapidly navigate the organization and identify, align, and integrate cross-functional resources into cohesive teams, • Demonstrated ability to work in a highly matrixed environment and manage supply chain initiatives in a high performing team across all levels, • Experience in multi-functional areas (Clinical Operations, Medical, Regulatory, Quality, Product/Process Development) demonstrating a broad understanding of pharmaceutical development, both in GCP and GMP, • Expert knowledge of all phases of drug development, of the functions and processes relevant to drug development, and project management principles applicable to the biopharmaceutical environment, • Extensive experience in planning and execution of investigational materials supply strategies

Job Description Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job overview: The Senior Statistical Programmer will contribute expert programming skills to deliver accurate, regulatory-compliant clinical data outputs for Compass Pathways development programs. The role requires strong technical proficiency, collaboration across teams, and adaptability to support complex clinical trial requirements. Location: Hybrid in our NYC Office or remote in the East Coast. Reports to: Associate Director, Statistics and Data Management. Duration: 9-month contract. Roles and Responsibilities (Include but are not limited to): • Leading and coordinating the programming activities within agreed timelines, • Managing the reporting of studies internally and externally, • Programming outputs as stated in the analysis plan, • Working closely with study team members, mainly with the study statistician, • Reviewing of the Statistical Analysis Plan (SAP) and shells, • Create and review SDTM and ADaM study specifications, • Ensure programs, datasets, outputs are appropriate for regulatory submission, • Perform simulations and data modelling, • Perform Interim analyses, • Extensive years experience in statistical programming, • CDISC expertise, • Proficient in programming including performing statistical analyses and creating macros in SAS, preferably R, • Programming/reporting expertise across all phases of clinical development (efficacy/safety/PK), including ISS/ISE reporting, • Experience in performing quality control (QC) checks, • Extensive knowledge in regulatory submission process, • Good understanding of ICH guidelines and regulations such as 21 CFR Part 11, • Experience supporting NDA submissions e.g., FDA, EMA, MHRA and addressing regulatory questions, • Ability to solve challenging problems and provide recommendations to mitigate risk, • Good communication skills - both written and verbal 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.

Job Description THE ORGANIZATION The Center for Justice Innovation is a nonprofit organization dedicated to advancing community safety and racial justice. Since 1996, we’ve worked alongside communities, courts, and those most directly affected by the justice system to build stronger, healthier, and more equitable neighborhoods. With a team of over 900 staff and an annual budget of $130 million, the Center carries out its mission through three core strategies: • Operating Programs that pilot new ideas and address local challenges;, • Conducting original research to evaluate what works—and what doesn’t; and THE OPPORTUNITY Brooklyn Justice Initiatives (BJI) seeks to reengineer the experience of criminal court in Brooklyn, New York by providing judges and attorneys meaningful alternatives to bail, fines, and jail sentences. Operating out of Kings County Criminal Court, Brooklyn Justice Initiatives is a team of social service providers, court-based resource coordinators, and others who seek to improve the quality of justice. By providing meaningful pre-trial supervised release and post-conviction sentencing options, Brooklyn Justice Initiatives seeks to use an arrest as a window of opportunity to change the direction of a participant’s life and avoid the harmful effects of incarceration. Brooklyn Justice Initiatives is seeking a Compliance Specialist. Reporting to the Compliance Manager, the Compliance Specialist will implement and execute strategies to ensure accurate compliance tracking and reporting for the Supervised Release team at BJI. The Compliance Specialist will also assist all Brooklyn Justice Initiatives with compliance concerns, audits, and data collection and entry. The Compliance Specialist will ensure programmatic deliverables are being met and provide both internal feedback and written updates to the Court including defense attorneys, Assistant District Attorneys, clerks, and Judges on a regular basis. The Compliance Specialist is also responsible for working with the Compliance Manager, the Associate Director of Compliance, and other Compliance Specialists to oversee the accuracy of internal data and execute quality assurance of BJI’s practices. Responsibilities include but are not limited to: • Engage in routine auditing of Brooklyn Justice Initiatives programs including: program compliance and other internal audits;, • Track participants’ progress in accordance with all grant requirements;, • Coordinate with court staff to provide participants’ compliance, eligibility, and case status to stakeholders, including prosecutors, defense attorneys, clerks, and other court staff;, • Provide written case updates to the court and other court staff including compliance and non-compliance reporting;, • Generate daily and weekly compliance memorandums detailing participants’ mandates, upcoming court dates, and outcomes;, • Coordinate across BJI programming for cross-over participants also within the Alternatives to Incarceration program;, • Maintain appropriate participant information in electronic databases, including, but not limited to, data entry and collection, mandate information and court outcome information;, • Assist the Compliance Manager, Associate Director of Compliance and senior management with the development and implementation of new programs, protocols, initiatives, and/or interventions;, • Assist with training initiatives for program staff and new hires;, • Work closely with the Center for Justice Innovation’s Data Analytics & Applied Research team to improve quality assurance of all BJI programming;, • Review and analyze internal trends and practices to support programmatic evaluation;, • Attend all required staff meetings (clinical team, all staff, etc.) and trainings, which may include non-traditional business hours; attend project events after hours, with advanced notice as needed; and Position Location: Brooklyn, NY. Compensation: The compensation range for this position is $52,000 - $65,400 and is commensurate with experience. Benefits: The Center for Justice Innovation offers an excellent benefits package including comprehensive healthcare with a national network, free basic dental coverage, vision insurance, short-term and long-term disability, life insurance, and flexible spending accounts including commuter FSA. We prioritize mental health care for our staff and offer services like Talkspace and Ginger through our healthcare plans. We offer a 403(b) retirement plan with a two-to-one employer contribution up to 5%. Note: This position is part of the NOLSW, UAW 2320 bargaining unit. The Center for Justice Innovation is an equal opportunity employer committed to fostering an inclusive and diverse workplace. We do not discriminate based on race, color, religion, gender identity, gender expression, pregnancy, national origin, age, military service eligibility, veteran status, sexual orientation, marital status, disability, or any other category protected by law. We strongly encourage and welcome applications from women, people of color, members of the LGBTQ+ community, and individuals with prior contact with the criminal justice system. Our goal is to create a supportive and respectful environment where everyone, regardless of background or identity, feels valued and included. At this time, the Center is unable to sponsor or take over sponsorship of an employment visa. All applicants must be legally authorized to work in the United States at the time of application and throughout the duration of employment. Candidates are expected to provide accurate and truthful information throughout the hiring process. Any misrepresentation, falsification, or omission of material facts may result in disqualification from consideration, withdrawal of an offer, or termination of employment, regardless of when discovered. In compliance with federal law, all hires must verify their identity and eligibility to work in the United States and complete the required employment verification form upon hire. Please refer to the job posting for relevant contact information. If contact details are not provided, we kindly ask that you refrain from inquiries via phone or email, as only shortlisted candidates will be contacted. Powered by JazzHR vz7AWUlhzg

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