Alumis · 15 hours ago
Associate Director, Data Management
South San Francisco, CA
Full-time
Hybrid
Lead/Staff, Director/Executive
$195K/yr - $225K/yr
10+ years expAlumis Inc. is a precision medicines company with a mission to transform the lives of patients with autoimmune diseases. The Associate Director, Data Management plays a central role in delivering high quality, inspection-ready clinical trial data across Alumis’ development programs, primarily supporting the Phase 3 program for envudeucitinib.
BiotechnologyHealth CareLife ScienceMedicalPrecision Medicine
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
Qualification
Required
10+ years of relevant clinical data management experience; BS or equivalent required (MS or MBA a plus)
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
Preferred
Local candidates are strongly preferred
Remote candidates may be considered if they can maintain Pacific Time business hours and travel to HQ approximately once per month, or as business needs require
Benefits
Medical, dental, and vision insurance with 90% of employee premiums and 80% of dependent premiums covered
401(k) plan with company match
Free access to the Genentech Bus Share program
$100 monthly cell phone stipend
Unlimited PTO for Exempt employees
Onsite gym and fully stocked kitchen with snacks and beverages
Company
Alumis
Alumis is a precision medicine company focused on the discovery, development and treatment of autoimmune disorders.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$917.19MKey Investors
Foresite CapitalMatrix Capital Management
2026-01-07Post Ipo Equity· $345.1M
2025-11-19Post Ipo Secondary· $3.09M
2024-07-23Post Ipo Equity· $40M
Leadership Team
Martin Babler
Chairman, President and CEO
K
Ken A Brameld
Fellow, Head of Discovery
Recent News
thefly.com
2026-01-16
Company data provided by crunchbase