Associate Director, Data Management

Role Summary

Associate Director, Data Management at Alumis leads end-to-end data management activities for late-stage clinical studies, delivering high-quality, inspection-ready trial data across Alumis’ development programs. The role primarily supports 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 enable data deliveries that support a planned New Drug Application (NDA) submission to the FDA in the second half of 2026. The role involves partnering with cross-functional teams and external vendors to ensure clinical data meets regulatory standards in a timely and high-quality manner, from managing database transfers and ongoing data review to driving timelines through database freeze and lock. The role is anchored in South San Francisco, CA; local candidates are preferred, with remote consideration for those who can maintain Pacific Time hours and travel to HQ approximately once per month or as needed.

Responsibilities

• 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
• 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)
• 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
• 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
• 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
• 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

Qualifications

• Extensive experience supporting Phase III clinical trials in a lead role
• Strong expertise in EDC systems and related technologies (e.g., IXRS, external data integrations, data visualization)
• Proficiency with CDISC standards (CDASH, SDTM, ADaM)
• Experience with SAS, SQL, and/or clinical programming tools
• Strong understanding of FDA regulations, ICH GCP, and inspection readiness expectations
• Working knowledge of MedDRA and WHO Drug coding dictionaries
• Excellent communication, organization, and cross-functional collaboration skills
• Demonstrated ability to manage multiple priorities, identify risks, solve complex problems, and adapt in a fast-paced environment
• Willingness to travel as needed

Education

• BS or equivalent required (MS or MBA a plus)