Associate Director, Data Management

Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. 

The Associate Director, Data Management plays a central role in delivering high quality, inspection-ready clinical trial data across Alumis’ development programs. This role will primarily support the Phase 3 program for envudeucitinib, a next-generation, highly selective oral TYK2 inhibitor for patients with moderate-to-severe plaque psoriasis. The Associate Director will be instrumental in enabling data deliveries that support a planned New Drug Application (NDA) submission to the FDA in the second half of 2026.

You will be joining Alumis at a pivotal and fast-paced stage of development. In this role, you will lead end-to-end data management activities for one or more late-stage clinical studies. You will partner closely with cross-functional teams and external vendors to ensure clinical data meets regulatory standards in a timely and high-quality manner to support key development and regulatory milestones. From managing database transfers and ongoing data review to driving timelines through database freeze and lock, you will drive late-stage processes that enable the advancement of therapies with the potential to meaningfully improve patients’ lives. 

Essential Responsibilities

Study Leadership & Delivery 

• Serve as Data Management Study Lead for a phase III study 
• Ensure DM deliverables are completed on time and in accordance with quality standards and regulatory requirements from study start-up through study closure/archival 
• Represent Data Management in cross-functional study team meetings 

Data Quality & Review  

• Perform supplemental data reviews according to the data quality checks outlined in the data validation specifications or Clinical Data Review Plan (CDRP) 
• Participate in reviews of blinded TFL output before final database locks 
• Report query trends and data/query/SDV metrics to the Study Execution Team (SET) 

Vendor & Cross-Functional Collaboration

• Establish and maintain strategic business relationships with CDM vendors; apply effective vendor management throughout the study 
• Participate in the RFP process, including the evaluation of potential vendors 
• Participate in study document reviews, e.g. clinical study protocols, statistical analysis plans, Mock Tables, Figures, and Listings (TFL) shells 

Document & Inspection Readiness

• Responsible for ensuring complete and accurate CDM documentation, such as eCRF specifications, eCRF completion guidelines, annotated CRFs, data validation specifications, data transfer agreements, and data management plans 
• Ensure DM project documentation is in an inspection-ready state 

 Operational Excellence  

• Prioritize projects and coordinate data management activities and deliverables in alignment with corporate goals and objectives 
• Contribute to or lead initiatives focused on data quality, efficiency, and process improvement 
• May provide line management or mentoring for DM support roles 

 Systems, Testing & Data Flow

• Perform thorough development testing of the eCRF prior to deployment, inclusive of creating User Acceptance Test (UAT) Plans, Test Scripts and executing testing as applicable 
• Ensure accurate development and execution of data integrations between EDC, IXRS and/or external vendor data sources 
• Responsible for setup and management of data transfers for assigned studies, including review of test data transfers for consistency with data transfer agreements 
• Participate in the development of EDC custom report specifications, SAS Clinical Programming report specifications and/or associated outputs as needed