Alexion Pharmaceuticals, Inc. · 17 hours ago
Associate Director, FAIR Data Operations
Waltham, Massachusetts, United States of America
Full-time
Onsite
Lead/Staff, Director/Executive
$128K/yr - $192K/yr
5+ years expAlexion Pharmaceuticals, Inc. is dedicated to advancing Oncology data science through innovative technology and data infrastructure. The Associate Director of FAIR Data Operations will lead the stewardship of molecular and imaging data from clinical trials, establishing practices and standards for data management and compliance.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Define the FAIR data roadmap, OKRs, and pragmatic standards for ingesting, curating, harmonizing, and provisioning molecular and imaging clinical data; drive enterprise metadata, ontology, and catalog adoption to enable findability and reuse
Serve as accountable data steward for genomic, proteomic, and other -omics readouts from clinical trials and for digital pathology/imaging modalities (e.g., WSI, radiology DICOM); ensure modality-specific QC, metadata capture, and traceability from site/vendor to analysis environment
Lead the design and implementation of data specifications, data transfer agreements (DTAs), and SLAs with CROs, central labs, biomarker assay providers, and imaging vendors; standardize templates and acceptance criteria; oversee onboarding and performance monitoring
Implement data/metadata standards and controlled vocabularies across modalities; embed privacy-by-design and regulatory compliance (e.g., GDPR) and align with clinical data standards and internal governance cadences
Drive delivery across cross-functional matrix teams of data SMEs, data engineers, alliance/partnership managers, clinical operations, translational biomarker leads, imaging scientists, biostatistics, quality/compliance, privacy/legal, procurement/vendor management, and IT/security. Orchestrate work plans, dependencies, and acceptance criteria; champion agile/DataOps practices to ensure timely, compliant, and reusable outputs without direct line management responsibilities
Translate scientific and operational needs into clear requirements and delivery plans; communicate risk, value, and trade-offs; drive adoption of standards and tools through training and change management
Qualification
Required
Master's degree in Data Science, Bioinformatics, Computational Biology, Life Sciences or related; PhD preferred
5+ years' experience in data management/operations within Life Sciences/Pharma R&D
Demonstrated stewardship of clinical molecular data (e.g., NGS, qPCR, proteomics) and imaging/digital pathology or radiology data within clinical trials, including QC pipelines, metadata capture, and compliance controls
Proven track record implementing and scaling FAIR practices across complex R&D data (digital pathology, genomics/-omics, clinical) with measurable impact on data findability, interoperability, and reuse
Hands-on experience defining data specs, mapping guides, transfer protocols, and DTAs; managing external partners and ensuring timely, quality-compliant data deliveries
Proficiency with Unix and Python, workflow orchestration (e.g., Airflow, Prefect), data modeling and standards/ontology implementation, data privacy/compliance, and strong stakeholder communication and documentation skills
Preferred
Agile (Scrum/Kanban), Jira/Confluence; data observability/quality tooling; cloud data platforms (e.g., AWS/Azure/GCP), data catalogs, lineage solutions
Familiarity with Gene Ontology, NCI Thesaurus, EFO, HPO, MeSH, BAO; resources such as NCBO BioPortal, EBI OLS; references including UniProt, Ensembl, ChEMBL, EntrezGene, ClinicalTrials.gov
Working knowledge of CDISC SDTM/ADaM and interoperability frameworks (FHIR/OMOP) for RWE integration; experience aligning biomarker/imaging datasets to clinical contexts and study metadata
Understanding of DICOM, WSI formats, PACS/LIMS integrations, digital pathology QC, and image-derived features; experience with image metadata standards and de-identification
Experience enabling operational and QC dashboards (e.g., Power BI/PowerQuery) and provisioning curated datasets to scientific users and statisticians
Benefits
Qualified retirement programs
Paid time off (i.e., vacation, holiday, and leaves)
Health, dental, and vision coverage in accordance with the terms of the applicable plans
Company
Alexion Pharmaceuticals, Inc.
Alexion, AstraZeneca Rare Disease is focused on pioneering new possibilities for the rare disease community.
1001-5000 employees
H1B Sponsorship
Alexion Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (49)
2024 (57)
2023 (51)
2022 (29)
2021 (27)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$5.8M2020-12-12Acquired
1999-02-12Post Ipo Equity· $5.8M
1996-02-29IPO
Leadership Team
Frederic Chereau
SVP, Strategy and Business Development
Imran Shakur
Director, IRT and Technology Lead
Recent News
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