
MoonLake Immunotherapeutics · UK
JOB PURPOSE As Manager Clinical Operations your will be responsible for the management of all aspects of the Clinical Study Team activities for assigned clinic...
As Manager Clinical Operations your will be responsible for the management of all aspects of the Clinical Study Team activities
for assigned clinical studies. This role is accountable for achieving successful execution and delivery of MoonLake’s clinical
development team activities at the study level by meeting company and regulatory requirements according to time, quality/scope and
budget constraints.
priorities and manage timelines.
study plans, relevant guidelines and contracts through regular vendor and/or investigator site contact.
appropriate.
procedures.
procedures and relevant standards.
SOPs and regulatory requirements.
MoonLake.
project team members as appropriate.
internal process/system development
Education: Bachelor’s degree in Life Sciences, Nursing or other health care professional equivalent.
would be an advantage.
team members.
An exciting job opportunity awaits you!
MoonLake is a dynamic and innovative company pushing the boundaries of possibility, and we are looking for passionate individuals
to join our stellar team.
Learning Environment: An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech
environment.
Impactful Work: Contribute to ground-breaking projects that have the potential to transform global healthcare.
Flexibility and Balance: Work remotely/hybrid, enjoying a healthy work-life balance while making meaningful contributions to our
team.
Career Growth: A clear path for career progression, with the chance to take on more responsibilities as you develop your skills.
Our Core Values
We look for potential MoonLakers that embody our three core values that drive our pursuit of excellence:
We do Stellar Science: We aspire to create novel therapies that elevate treatment horizons, with innovative science, and high
quality, always.
We go beyond: We aspire to be positively disruptive in our field, and bold in the way we challenge the norms and each other.
We unlock value: We aspire to create long-term value for investors and communities.
DEINE MISSION BEI UNS Gestalte die Zukunft der Schmerztherapie mit uns! In dieser Rolle sorgst Du für höchste Qualitätsstandards in unseren klinischen Studien. Du gestaltest unser Clinical Quality Assurance System aktiv mit, erkennst Risiken frühzeitig und stellst die Einhaltung regulatorischer Anforderungen sicher. In enger Zusammenarbeit mit internen Teams und externen Partnern treibst Du Verbesserungen voran und sorgst dafür, dass Qualität konsequent umgesetzt wird. Bereit, Verantwortung zu übernehmen und wirklich etwas zu bewegen? Dann suchen wir genau Dich! DEINE AUFGABEN * Du bist für die Mitgestaltung, Betreuung und Verbesserung unseres CQA-Systems verantwortlich * Dein Fokus liegt auf der Identifikation, Dokumentation, Bewertung, und der Nachbearbeitung von Protocol Deviations und Non-Compliances an Studienzentren * Du identifizierst dabei frühzeitig Trends, um präventive Maßnahmen zu ergreifen * Du verantwortest die Abstimmung mit externen Dienstleistern (z.B. Monitoring CROs) zur Prävention und Abstellung von Non-Compliances durch die Entwicklung von CAPA-Maßnahmen * Du fungierst als Sparringspartner zu unserem Clinical Operations Team bezüglich aller Zentrums-bezogenen GCP-Themen DEIN PROFIL * Du hast ein abgeschlossenes-Studium im Bereich Medizin, Naturwissenschaften, Pharmazie, Biotechnologie o.ä. * Du bringst mind. 1 Jahr Vorerfahrung in der klinischen Forschung und Qualitätssicherung mit * Du hast bereits ein vertieftes Verständnis von ICH GCP E6 und angrenzenden Regularien * Du verfügst über Erfahrung in der Gestaltung und Verbesserung von Unternehmensprozessen * Du arbeitest selbständig, ergebnisorientiert und strukturiert * Du bringst verhandlungssichere Deutsch- und Englischkenntnisse (mind. C1-Level) mit ÜBER UNS Vertanical ist ein weltweit führendes Biopharmaunternehmen, das sich auf die Entwicklung und den Vertrieb innovativer Arzneimittel zur Behandlung chronischer Schmerzen spezialisiert hat. Dabei verfolgen wir eine klare Vision: Eine Welt frei von chronischen Schmerzen! Mit VER-01 haben wir ein einzigartiges cannabinoidbasiertes Arzneimittel zur Behandlung chronischer Schmerzen entwickelt, das im Juni 2026 unter dem Namen Exilby in Deutschland und Österreich zugelassen wurde. Damit haben wir nach mehr als acht Jahren intensiver Forschungs- und Entwicklungsarbeit einen bedeutenden Meilenstein erreicht. Die Zulassung in den USA ist für 2029 geplant. Unser Ziel ist es, Exilby bis 2030 als führende Therapie zur Behandlung chronischer Schmerzen zu etablieren und damit neue Maßstäbe in der Schmerztherapie zu setzen. Für Dich klingt das spannend? Dann bewirb Dich jetzt! UNSER VERSPRECHEN Wir bieten Dir einen vielfältigen, anspruchsvollen Job mit spannenden Aufgaben und einem breiten Spektrum an Gestaltungsmöglichkeiten! Unser innovatives Umfeld ermöglicht Dir Deine berufliche Entfaltung mit kurzen Entscheidungswegen, Verantwortung von Tag 1 an und den Freiraum, neue Wege zu gehen. Auf Dich wartet individuelles Learning und echte Sinnhaftigkeit – schenke mit Deinem persönlichen Beitrag Millionen von Menschen ein neues Leben! DEIN DIREKTER KONTAKT ZU UNSERER HR ABTEILUNG Bewirb Dich jetzt! Wir freuen uns darauf, Dich kennenzulernen. Du hast Rückfragen? Wende Dich gerne direkt an Deinen zuständigen Ansprechpartner: FUTRUE GmbH Vanessa Köpfler Am Haag 14 82166 Gräfelfing jobs@futrue.com https://futrue.com *Aus Gründen der besseren Lesbarkeit wird in dieser Anzeige die männliche Form verwendet. Sie bezieht sich ausdrücklich auf alle Geschlechter (w/m/d).
Claratel Behavioral Health (formerly known as DeKalb Community Service Board) is an innovative, community-based behavioral health and developmental disabilities services organization located in metropolitan Atlanta, Georgia, offering a full range of mental health services, developmental disabilities programs and substance abuse treatment to more than 11,000 citizens annually who are uninsured and underinsured. As a public, not-for-profit organization, Claratel BH operates in DeKalb County with a diverse workforce of more than 500 direct-care and support staff and more than 20 locations across the county. Our staff of physicians, nurses, clinicians and support personnel are dedicated to helping our clients and their families recover from these debilitating disabilities and resume productive lives. We strive to provide the highest quality, evidence-based services in the least restrictive settings, and we envision a community in which disabilities no longer limit potential. Claratel BH is accredited by the Commission on Accreditation of Rehabilitation Facilities (CARF). The DeKalb Regional Crisis Center provides crisis intervention and stabilization services for adults. The Center offers three levels of care starting with the Crisis Services Center unit that receives walk-ins, transfers from emergency rooms, and involuntary referrals for evaluation. If further observation is needed, individuals are monitored in the Temporary Observation Unit for 12-24 hours. Individuals needing a longer period of stabilization or substance withdrawal management (usually 5-7 days) are admitted to the Crisis Stabilization Unit where ongoing care includes crisis counseling, medication, and assistance with discharge planning. The DeKalb Regional Crisis Center (DRCC) provides crisis intervention and stabilization services for adults across three levels of care: * Psychiatric Emergency Services (PES): Rapid intake, triage, and evaluation of walk-ins, law enforcement drop-offs, ER transfers, and involuntary referrals. * Temporary Observation (Temp Observations): 12–24 hours of monitoring and evaluation for clients needing extended stabilization. * Crisis Stabilization Unit (CSU): 5–7-day admissions for psychiatric stabilization and/or withdrawal management, with crisis counseling, medication, and discharge planning. Position Summary: The Clinical Manager provides clinical leadership and oversight for all non-medical behavioral health clinical services within the Psychiatric Emergency Services (PES) and the Crisis Stabilization Unit (CSU). For purposes of organizational structure, clinical services refer specifically to non-medical behavioral health treatment, including therapy, case management, clinical assessments, treatment planning, and discharge coordination. This role ensures delivery of high-quality, trauma-informed, and recovery-oriented care throughout each client’s transition through care at DRCC. This role reports directly to the Director and collaborates closely with the rest of the interdisciplinary team across the PES and the CSU to support integrated, safe, and effective crisis services in a 24/7 operational environment. Duties and Responsibilities Clinical Oversight and Supervision: * Provide direct clinical supervision to licensed clinicians, associate-licensed clinicians, case managers, and certified peer specialists. * Ensure delivery of evidence-based, recovery-oriented, and trauma-informed therapeutic care. * Oversee timely and accurate completion of clinical assessments, treatment plans, progress notes, and discharge summaries. * Provide consultation on complex clinical cases and ethical decision-making. * Support staff development through coaching and feedback. Program Development and Clinical Operations: * Lead development and refinement of PES & CSU therapeutic programming. * Evaluate therapy and case management workflows. * Review utilization and outcome data to inform improvements. Compliance and Quality Improvement: * Ensure accurate and compliant documentation in the EHR. * Supports utilization review through clinical justification. * Participate in quality improvement and accreditation readiness activities. Provides Leadership for 24/7 Crisis Center Operations * Serves as escalation point for non-medical clinical concerns. * Provide on-site and on-call leadership in a 24/7 facility including during weather events, facility disruptions, staffing shortages, or other emergencies. * Make real-time clinical operational decisions during emergencies. * Collaborates closely with Crisis Center Leadership and defers all medical, nursing, and safety decisions appropriately. * Model trauma-informed leadership during high-stress situations. Supervisory Responsibility * Directly supervise licensed clinicians, associate-licensed clinicians, PES & CSU case managers, and certified peer specialists. QUALIFICATIONS Required * Master’s degree in social work, psychology, counseling, or related field. * Current Georgia licensure as LCSW or LPC. * Minimum of three (3) years clinical experience in crisis services. * Minimum of two (2) years in a supervisory role. Preferred * Five or more years clinical experience in crisis services. * Three or more years in a supervisory role. Physical Requirements & Work Environment * Ability to stand, walk, and move throughout the facility for extended periods. * Ability to respond rapidly to crises and urgent situations. * Ability to remain on site for extended periods during emergencies. * Ability to lift, carry, push, or pull up to 25 pounds. * Ability to sit for prolonged periods for documentation. * Visual, auditory, and verbal abilities are sufficient to observe and communicate effectively. * 24/7 behavioral health crisis stabilization setting. * Exposure to individuals in acute psychiatric distress. * Fast-paced environment with periods of high stress. * May require evenings, weekends, holidays, or extended shifts during emergencies. For more information visit www.claratel.org/careers [http://www.dekcsb.org/careers] Claratel Behavioral Health is an equal opportunity employer regarding disability under VEVRRA and ADA
Claratel Behavioral Health (formerly known as DeKalb Community Service Board) is an innovative, community-based behavioral health and developmental disabilities services organization located in metropolitan Atlanta, Georgia, offering a full range of mental health services, developmental disabilities programs and substance abuse treatment to more than 11,000 citizens annually who are uninsured and underinsured. As a public, not-for-profit organization, Claratel BH operates in DeKalb County with a diverse workforce of more than 500 direct-care and support staff and more than 20 locations across the county. Our staff of physicians, nurses, clinicians and support personnel are dedicated to helping our clients and their families recover from these debilitating disabilities and resume productive lives. We strive to provide the highest quality, evidence-based services in the least restrictive settings, and we envision a community in which disabilities no longer limit potential. Claratel BH is accredited by the Commission on Accreditation of Rehabilitation Facilities (CARF). The DeKalb Regional Crisis Center provides crisis intervention and stabilization services for adults. The Center offers three levels of care starting with the Crisis Services Center unit that receives walk-ins, transfers from emergency rooms, and involuntary referrals for evaluation. If further observation is needed, individuals are monitored in the Temporary Observation Unit for 12-24 hours. Individuals needing a longer period of stabilization or substance withdrawal management (usually 5-7 days) are admitted to the Crisis Stabilization Unit where ongoing care includes crisis counseling, medication, and assistance with discharge planning. The DeKalb Regional Crisis Center (DRCC) provides crisis intervention and stabilization services for adults across three levels of care: * Psychiatric Emergency Services (PES): Rapid intake, triage, and evaluation of walk-ins, law enforcement drop-offs, ER transfers, and involuntary referrals. * Temporary Observation (Temp Observations): 12–24 hours of monitoring and evaluation for clients needing extended stabilization. * Crisis Stabilization Unit (CSU): 5–7-day admissions for psychiatric stabilization and/or withdrawal management, with crisis counseling, medication, and discharge planning. Position Summary: The Clinical Manager provides clinical leadership and oversight for all non-medical behavioral health clinical services within the Psychiatric Emergency Services (PES) and the Crisis Stabilization Unit (CSU). For purposes of organizational structure, clinical services refer specifically to non-medical behavioral health treatment, including therapy, case management, clinical assessments, treatment planning, and discharge coordination. This role ensures delivery of high-quality, trauma-informed, and recovery-oriented care throughout each client’s transition through care at DRCC. This role reports directly to the Director and collaborates closely with the rest of the interdisciplinary team across the PES and the CSU to support integrated, safe, and effective crisis services in a 24/7 operational environment. Duties and Responsibilities Clinical Oversight and Supervision: * Provide direct clinical supervision to licensed clinicians, associate-licensed clinicians, case managers, and certified peer specialists. * Ensure delivery of evidence-based, recovery-oriented, and trauma-informed therapeutic care. * Oversee timely and accurate completion of clinical assessments, treatment plans, progress notes, and discharge summaries. * Provide consultation on complex clinical cases and ethical decision-making. * Support staff development through coaching and feedback. Program Development and Clinical Operations: * Lead development and refinement of PES & CSU therapeutic programming. * Evaluate therapy and case management workflows. * Review utilization and outcome data to inform improvements. Compliance and Quality Improvement: * Ensure accurate and compliant documentation in the EHR. * Supports utilization review through clinical justification. * Participate in quality improvement and accreditation readiness activities. Provides Leadership for 24/7 Crisis Center Operations * Serves as escalation point for non-medical clinical concerns. * Provide on-site and on-call leadership in a 24/7 facility including during weather events, facility disruptions, staffing shortages, or other emergencies. * Make real-time clinical operational decisions during emergencies. * Collaborates closely with Crisis Center Leadership and defers all medical, nursing, and safety decisions appropriately. * Model trauma-informed leadership during high-stress situations. Supervisory Responsibility * Directly supervise licensed clinicians, associate-licensed clinicians, PES & CSU case managers, and certified peer specialists. QUALIFICATIONS Required * Master’s degree in social work, psychology, counseling, or related field. * Current Georgia licensure as LCSW or LPC. * Minimum of three (3) years clinical experience in crisis services. * Minimum of two (2) years in a supervisory role. Preferred * Five or more years clinical experience in crisis services. * Three or more years in a supervisory role. Physical Requirements & Work Environment * Ability to stand, walk, and move throughout the facility for extended periods. * Ability to respond rapidly to crises and urgent situations. * Ability to remain on site for extended periods during emergencies. * Ability to lift, carry, push, or pull up to 25 pounds. * Ability to sit for prolonged periods for documentation. * Visual, auditory, and verbal abilities are sufficient to observe and communicate effectively. * 24/7 behavioral health crisis stabilization setting. * Exposure to individuals in acute psychiatric distress. * Fast-paced environment with periods of high stress. * May require evenings, weekends, holidays, or extended shifts during emergencies. For more information visit www.claratel.org/careers [http://www.dekcsb.org/careers] Claratel Behavioral Health is an equal opportunity employer regarding disability under VEVRRA and ADA