Senior Study Manager

pbReporting to: /b Head of Clinical Operations /ph3Company Context /h3pNumab Therapeutics AG is a Swiss‑headquartered biotechnology company based in Horgen, Zurich canton, dedicated to developing multi‑specific antibody‑based immunotherapies. Using its proprietary λ‑Cap™ and MATCH™ technology platforms, Numab designs and engineers multi‑specific antibodies that combine best‑in‑class potency, stability, and pharmacokinetic properties. /ppThe company has built a broad and differentiated pipeline of in‑house programs across immunology and oncology, and has established multiple collaborations with leading global pharmaceutical partners—underlining the scalability and external validation of its platform and business model. In 2024 the company completed a major transaction with Johnson Johnson through the sale of its subsidiary (Yellow Jersey Therapeutics) which included rights to NM26‑2198 in a deal valued at approximately USD 1.25 billion. In early 2025, the Series C fundraising was extended to CHF 180 million to support several first‑and best‑in‑class programs. /ph3Role Purpose /h3pNumab is preparing its lead inflammatory bowel disease programme for first‑in‑human development. This is a hands on study leadership role at a pivotal moment and the successful candidate will create clarity, pace and control across a fast moving, outsourced development model. They will be the day‑to‑day operational lead on a phase 1 study, partner closely with the CRO, clinical sites, vendors and internal functions to ensure sites, systems, supplies and data are ready throughout study start up and execution. /ppThe role suits a scientifically credible early phase study manager who can identify critical path dependencies, challenge partners constructively, drive issues through to resolution and who is comfortable making sound decisions in a lean biotech setting. It offers direct ownership, meaningful vendor influence and the chance to help establish the operational foundations for future studies. /ph3Key Responsibilities /h3h3Study delivery and CRO Leadership /h3ulliLead operational delivery of assigned Phase I studies, from start‑up through close out and reconciliation /liliAct as Numab's day‑to‑day operational counterpart to the CRO, setting clear expectations, tracking commitments and driving timely resolution of study issues. /liliDevelop and maintain integrated study plans, milestones, risk and issue logs and decision records to elevate material risks early with practical mitigation options. /liliReview CRO deliverables, including monitoring reports, study status updates, relevant operational plans and ensure actions are owned to completion. /liliCoordinate operational readiness for dose‑escalation and safety review meetings, ensuring required safety, PK and operational data are available, actions are documented and decisions are rapidly implemented across the CRO, sites and vendors. /liliSupport study governance, including preparation of concise, decision ready updates for the Head of Clinical Operations and cross‑functional stakeholders. /liliContribute to operational forecasting and management of study scope, timelines, critical path dependencies, change control, budgets and vendor performance. /liliLead operational implementation of protocol amendments and study expansions, coordinating the CRO, sites and internal functions to translate approved changes into executable study plans. /li /ulh3Sites and participant operations /h3ulliOwn the relationship with key sites for, ensuring clear operating rhythm, site readiness and ensuring timely resolution of study issues. /liliPartner with the CRO and sites to conduct and assess feasibility, select appropriate sites and drive activation readiness. /liliEnsure practical readiness for site activation, including essential documents, staff training, system access, investigational product and sample workflows, laboratory and pharmacy arrangements and recruitment plans. /liliTrack recruitment and screening performance, including site‑level recruitment assumptions, screening and screen‑failure metrics, recruitment forecasts and emerging enrolment risks. Work proactively with sites and the CRO to implement mitigation plans, including for barriers arising from complex eligibility criteria. /liliTravel to investigator sites when needed to support feasibility, activation, relationship management and resolution of critical study issues. /li /ulh3Data systems, supplies and quality /h3ulliWork with CRO and relevant internal experts to support setup, testing and fit‑for‑purpose use of EDC and other clinical systems (for example eTMF, IRT/RTSM and safety interfaces as applicable). /liliOversee site data entry quality and timeliness, using CRO and site reporting to drive query resolution and protect data integrity. /liliCoordinate investigational product and clinical supply readiness, including forecasting,batch release and shipment to sites, reconciliation and escalation of supply risks. /lili. Coordinate operational execution of PK, ADA/immunogenicity, biomarker and other protocol‑defined sample strategies, ensuring collection schedules, laboratory manuals, sample logistics, assay readiness, responsibilities and data‑transfer timelines are aligned across sites and vendors /liliCoordinate operational delivery across study vendors, including the CRO, central and specialist laboratories, bioanalytical partners, IRT/RTSM and other service providers, ensuring interfaces, responsibilities, timelines and escalation pathways are clear. /liliEnsure study conduct meets ICH GCP, applicable regulations, protocol requirements, SOPs and quality expectations; support audit/inspection readiness and CAPA follow‑up where required. /liliPartner with Clinical, Regulatory, CMC, Biometrics, Safety and Quality colleagues to ensure operational plans align with submission, study set‑up and data review needs. /li /ulh3Key Qualifications Experience /h3ulliSubstantial clinical operations experience, including direct ownership of early phase clinical study delivery. Experience of PhI healthy volunteer and dose‑escalation studies is essential. /liliStrong practical understanding of the demands of first‑in‑human studies, including start‑up, participant safety, complex eligibility assessment, dose‑escalation decision support and intensive site/CRO coordination. /liliExperience working in biotech is highly desired /liliDemonstrable experience managing CROs and clinical sites, with the confidence to challenge constructively, influence senior stakeholders and hold partners to agreed commitments. /liliExperience in country and site feasibility, activation and participant recruitment, including specialised Phase I units and multi‑site patient studies. Demonstrated ability to manage recruitment challenges and site performance is strongly preferred. /liliExperience supporting studies through significant protocol amendments, cohort expansion or transition from healthy volunteers into patient populations /liliWorking knowledge of clinical data capture and trial systems, with experience supporting EDC set‑up, data entry quality and operational data review. /liliExperience in inflammatory bowel disease, immunology, gastroenterology would be highly desirable /li /ulpPlease note that applications that do not meet the requirements will not be considered. /p #J-18808-Ljbffr