Associate Director, Data Management
About The Position
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.
Requirements
- 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
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
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
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What This Job Offers
Job Type
Full-time
Career Level
Director
Number of Employees
101-250 employees
