Director, Data Management

South San Francisco

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. 

As a Director of Data Management, you will play a critical role in ensuring the integrity, quality, and readiness of clinical data that will drive key decisions across our development programs—including ongoing studies in lupus and beyond. 

In this role, you will lead data management activities across multiple studies, partnering closely with cross-functional teams to ensure our data not only meets regulatory standards but also tells a clear and actionable story. From CRF design and database development to data transfer agreements and database lock, you will guide critical processes that support the advancement of therapies with the potential to change patients’ lives. 

This role reports to the Vice President of Data Management and offers a unique opportunity to contribute to a high-performing team at the forefront of immunology drug development. 

 

Responsibilities: 

  • Lead and deliver: May serve as the Data Management Program Lead; Will serve as Study Lead across multiple clinical trials, owning data management from study start-up through database lock and archival. 
  • Team leadership and mentoring: Manage and develop data management study leads and supporting team members; foster a high-performance, collaborative culture. 
  • Vendor oversight: Establish and manage relationships with contract research organizations and data management vendors; oversee scope, timelines, performance, and compliance. 
  • Standards and systems: Drive case report form design and clinical database builds; oversee integrations between electronic data capture systems and interactive response technologies (electronic data capture and interactive response technology/interactive voice response systems). 
  • Testing and readiness: Lead user acceptance testing by creating test plans and scripts and executing test cycles to ensure system readiness. 
  • Documentation: Author and review core data management documentation, including case report form specifications and annotations, case report form completion guidelines, Data Management Plans, Data Validation Specifications, and Data Transfer Specifications and agreements; maintain inspection-ready files. 
  • Data quality: Execute and oversee validation checks and ongoing reviews according to the Clinical Data Review Plan; manage routine data transfers and reconcile external data to ensure accuracy and consistency. 
  • Cross-functional collaboration: Represent Data Management with Clinical Operations, Biostatistics and Statistical Programming, Regulatory Affairs, and Medical teams; review clinical protocols, Statistical Analysis Plans, and mock tables, figures, and listings; support blinded data reviews prior to database lock. 
  • Metrics and reporting: Track and communicate data quality and cleaning metrics, including query trends and source data verification progress, to study teams and stakeholders. 
  • Process improvement: Lead initiatives that enhance data quality, efficiency, and scalability through improved processes, tooling, and automation. 
  • RFP participation: Contribute to vendor requests for proposals, technical evaluations, and contract and budget discussions. 

 

Qualifications: 

  • 12+ years of relevant experience and has earned a BS or equivalent degree; MS or MBA a plus 
  • Experience running Ph I-IV clinical trials, both in-house and through CRO partners 
  • Strong knowledge and experience in EDC and other key technologies (e.g., IXRS, data visualization)  
  • Proficiency in CDISC standards (CDASH, SDTM, ADaM) 
  • Experience with SAS, SQL and/or other clinical programming tools 
  • Proficiency in clinical research regulations and guidance, including FDA CFR and ICH GCP  
  • Depth of experience across all aspects of DM, including but not limited to: CRF and database development, data quality assurance and analytics, data transfer management, vendor management, DM study documentation and inspection readiness.  
  • Strong understanding of the application of MedDRA and WHO Drug clinical data coding classification systems 
  • Strong interpersonal, organizational, and communication (oral and written) skills 
  • Demonstrated ability to cultivate strong working relationships with internal and external colleagues. 
  • Logical thinking, attention to detail and accuracy, strong organizational skills, and problem-solving abilities 
  • Ability to prioritize and to adapt quickly to changing business conditions with a “can-do” attitude 
  • Capable of proactively identifying project challenges and risks and proposing appropriate and strategic solutions to issues. 
  • Willing to travel if required  

 

Alumis Values 
• We Elevate 
• We Challenge 
• We Nurture 

 

This position is located in South San Francisco, CA. At this time, we are not considering remote applicants.  

The salary range for this position is $190,000 USD to $235,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices. 

 

Alumis Inc. is an equal opportunity employer. If you are hired, we will require you to prove that you have received the primary series of an FDA-approved or authorized COVID -19 vaccine and at least one booster or have a valid religious or medical reason not to be vaccinated. 

 

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