Overview
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.
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
Participate in data quality checks and reviews according to the data validation specifications or Clinical Data Review Plan (CDRP)
Review 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 and apply effective vendor management throughout the study
Participate in the RFP process, including the evaluation of potential vendors
Participate in study document reviews (protocols, statistical analysis plans, Mock Tables, Figures, and Listings shells)
Ensure CDM documentation is complete and accurate (eCRF specifications, eCRF completion guidelines, annotated CRFs, data validation specifications, data transfer agreements, data management plans)
Maintain inspection-ready project documentation
Prioritize projects and coordinate data management activities in alignment with corporate goals
Contribute to or lead initiatives focused on data quality, efficiency, and process improvement
May provide line management or mentoring for DM support roles
Perform development testing of the eCRF prior to deployment, including User Acceptance Test (UAT) Plans and Test Scripts
Ensure accurate development and execution of data integrations between EDC, IXRS and/or external data sources
Manage data transfers for assigned studies and review test data transfers for consistency with data transfer agreements
Develop EDC custom report specifications and SAS outputs as needed
Qualifications
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
This role is anchored at our
South San Francisco, CA
headquarters, and 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.
The salary range for this position is $185,000 USD to $215,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices. Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program.
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
And more!
We are a hard-working, collaborative team on a mission to transform patient’s lives -- and we aspire to elevate, challenge and nurture one another along the way. Alumis Inc. is an equal opportunity employer.
#J-18808-Ljbffr
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.
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
Participate in data quality checks and reviews according to the data validation specifications or Clinical Data Review Plan (CDRP)
Review 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 and apply effective vendor management throughout the study
Participate in the RFP process, including the evaluation of potential vendors
Participate in study document reviews (protocols, statistical analysis plans, Mock Tables, Figures, and Listings shells)
Ensure CDM documentation is complete and accurate (eCRF specifications, eCRF completion guidelines, annotated CRFs, data validation specifications, data transfer agreements, data management plans)
Maintain inspection-ready project documentation
Prioritize projects and coordinate data management activities in alignment with corporate goals
Contribute to or lead initiatives focused on data quality, efficiency, and process improvement
May provide line management or mentoring for DM support roles
Perform development testing of the eCRF prior to deployment, including User Acceptance Test (UAT) Plans and Test Scripts
Ensure accurate development and execution of data integrations between EDC, IXRS and/or external data sources
Manage data transfers for assigned studies and review test data transfers for consistency with data transfer agreements
Develop EDC custom report specifications and SAS outputs as needed
Qualifications
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
This role is anchored at our
South San Francisco, CA
headquarters, and 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.
The salary range for this position is $185,000 USD to $215,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices. Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program.
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
And more!
We are a hard-working, collaborative team on a mission to transform patient’s lives -- and we aspire to elevate, challenge and nurture one another along the way. Alumis Inc. is an equal opportunity employer.
#J-18808-Ljbffr