Senior Study Manager - IBD

OpenKrill; United States; Hybrid; USD 146,000 - 218,000; Full time

Job summary

Numab Therapeutics AG in Switzerland/UK is seeking a Senior Study Manager (Immunology) to lead Phase I studies, manage CROs, and drive site activation and recruitment. You will oversee data systems, safety data readiness, and protocol amendments in a lean biotech setting.

The role emphasizes early‑phase study leadership, cross‑functional collaboration, and direct ownership of study plans, timelines, and budgets. International collaboration with sites and vendors is expected.

Qualifications

• Substantial clinical operations experience in early phase trials.
• Experience leading CROs and coordinating multi-site studies.
• Strong understanding of dose escalation and safety reviews.
• Familiarity with trial systems and data quality controls.

Responsibilities

• Lead operational delivery of Phase I studies from start-up to close-out.
• Act as day-to-day operational counterpart to CRO; set expectations and track commitments.
• Develop integrated study plans, milestones, and risk logs to accelerate modifications.
• Review CRO deliverables and ensure actions are completed.
• Coordinate readiness for dose-escalation and safety review meetings.
• Support study governance with concise updates for leadership.
• Forecast study scope, timelines, budgets and vendor performance.
• Lead protocol amendments and study expansions with internal and CRO teams.
• Maintain site readiness, activation, and recruitment progress.
• Ensure data systems readiness and data integrity across sites.

Skills

Early-phase study leadership

CRO management

Site activation & recruitment

Dose-escalation studies

Budget & vendor management

ICH/GCP knowledge

Education

Advanced degree in life sciences

Job description

Senior Study Manager (Immunology)

Location: Horgen, Switzerland / United Kingdom

Reporting to: Head of Clinical Operations

Company Context

Numab 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.

The 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 USD1.25billion. In early 2025, the Series C fundraising was extended to CHF180million to support several first- and best-in‑class programs.

Role Purpose

Numab 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.

The 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.

Key Responsibilities

Study delivery and CRO Leadership

• Lead operational delivery of assigned Phase I studies, from start-up through close out and reconciliation
• Act as Numab's day‑to‑day operational counterpart to the CRO, setting clear expectations, tracking commitments and driving timely resolution of study issues.
• Develop and maintain integrated study plans, milestones, risk and issue logs and decision records to accelerate needed modifications.
• Review CRO deliverables, including monitoring reports, study status updates, relevant operational plans and ensure actions are owned to completion.
• Coordinate 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.
• Support study governance, including preparation of concise, decision ready updates for the Head of Clinical Operations and cross‑functional stakeholders.
• Contribute to operational forecasting and management of study scope, timelines, critical path dependencies, change control, budgets and vendor performance.
• Lead operational implementation of protocol amendments and study expansions, coordinating the CRO, sites and internal functions to translate approved changes into executable study plans.

Sites and participant operations

• Own the relationship with key sites for, ensuring clear operating rhythm, site readiness and ensuring timely resolution of study issues.
• Partner with the CRO and sites to conduct and assess feasibility, select appropriate sites and drive activation readiness.
• Ensure practical readiness for site activation, including essential documents, staff training, system access, investigational product and sample workflows, laboratory and pharmacy arrangements and recruitment plans.
• Track 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.
• Travel to investigator sites when needed to support feasibility, activation, relationship management and resolution of critical study issues.

Data systems, supplies and quality

• Work 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).
• Oversee site data entry quality and timeliness, using CRO and site reporting to drive query resolution and protect data integrity.
• Coordinate investigational product and clinical supply readiness, including forecasting,batch release and shipment to sites, reconciliation and escalation of supply risks.
• . 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
• Coordinate 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.
• Ensure study conduct meets ICH GCP, applicable regulations, protocol requirements, SOPs and quality expectations; support audit/inspection readiness and CAPA follow‑up where required.
• Partner with Clinical, Regulatory, CMC, Biometrics, Safety and Quality colleagues to ensure operational plans align with submission, study set‑up and data review needs.

Key Qualifications & Experience

• Substantial clinical operations experience, including direct ownership of early phase clinical study delivery. Experience of PhI healthy volunteer and dose‑escalation studies is essential.
• Strong 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.
• Experience working in biotech is highly desired
• Demonstrable experience managing CROs and clinical sites, with the confidence to challenge constructively, influence senior stakeholders and hold partners to agreed commitments.
• Experience 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.
• Experience supporting studies through significant protocol amendments, cohort expansion or transition from healthy volunteers into patient populations
• Working knowledge of clinical data capture and trial systems, with experience supporting EDC set‑up, data entry quality and operational data review.
• Experience in inflammatory bowel disease, immunology, gastroenterology would be highly desirable

Posting details

Please note that applications that do not meet the requirements will not be considered.

Application deadline is Thursday 5th November.