[Hiring] Senior Study Manager @Numab

Role Description

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, partnering 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
• Make 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.

Qualifications

• 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.
• Experience working in biotech is highly desired.
• Demonstrable experience managing CROs and clinical sites.
• Experience in country and site feasibility, activation, and participant recruitment.
• Experience supporting studies through significant protocol amendments.
• Working knowledge of clinical data capture and trial systems.
• Experience in inflammatory bowel disease, immunology, gastroenterology would be highly desirable.

Requirements

• 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.
• Develop and maintain integrated study plans, milestones, risk and issue logs, and decision records.
• Review CRO deliverables, including monitoring reports and study status updates.
• Coordinate operational readiness for dose-escalation and safety review meetings.
• Support study governance, including preparation of concise, decision-ready updates.
• Contribute to operational forecasting and management of study scope, timelines, and budgets.
• Lead operational implementation of protocol amendments and study expansions.
• Own the relationship with key sites, ensuring clear operating rhythm and site readiness.
• Partner with the CRO and sites to conduct and assess feasibility.
• Ensure practical readiness for site activation.
• Track recruitment and screening performance, including site-level recruitment assumptions.
• Travel to investigator sites when needed.
• Work with CRO and relevant internal experts to support setup and testing of clinical systems.
• Oversee site data entry quality and timeliness.
• Coordinate investigational product and clinical supply readiness.
• Coordinate operational delivery across study vendors.
• Ensure study conduct meets ICH GCP, applicable regulations, and quality expectations.
• Partner with Clinical, Regulatory, CMC, Biometrics, Safety, and Quality colleagues.

Company Description

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.

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.