Associate Director Biometrics Standards & Integrations
Scorpion Therapeutics, Rancho Santa Fe, CA, United States
Role Summary
Responsible for executing strategy to scale and accelerate biometrics deliverables by leveraging existing standards and processes to implement automation-centric, AI-enabled workflows that ensure regulatory-compliant data collection, analysis, and reporting. Works with project leads in Data Management, Statistical Programming and Biostatistics to operationalize data and analysis requirements into automated workflows within a regulatory-compliant framework deeply rooted in reusable metadata, lifecycle governance, content reuse and responsible AI controls. Identifies opportunities and partners with leadership to prioritize and design tools that facilitate seamless integration among Data Management, Statistical Programming and Biostatistics to scale and support a growing portfolio and ensure regulatory compliance and inspection readiness.
Responsibilities
Implement and champion continuous improvement of foundational standards that enable automation and consistent execution across studies (e.g., standards rulesets, mappings, reusable templates, workflow checklists, and controlled specifications)
Drive standards implementation and operationalization aligned to CDISC expectations, including linkage between CDASH-compliant data collection and downstream CDISC-compliant data and subsequent Neurocrine standard analysis/reporting
Support design and quality of submission-critical outputs, including the Define-XML package, ensuring traceability, consistency and an inspection-readiness mindset
Build and deploy low/no-code automations that improve standards adherence and consistency, handoff quality between Data Management, Statistical Programming and Biostatistics, repeatability of analysis and reporting workflows, inspection readiness through controlled outputs and documentation
Enable governed AI use within Biometrics (creating and implementing use cases, access restrictions, peer review, and automated checks)
Define inspection-ready evidence for automated/AI-assisted outputs
Provide training and technical support to end users for effective adoption and utilization of AI and automation solutions
Shape, with buy-in and endorsement from ADS Leaders, the ADS technology strategy by guiding the adoption of innovative technologies and encouraging a culture of creativity and continuous improvement
Drive innovation within biometrics by identifying and implementing new tools, technologies, and methodologies to enhance efficiency and effectiveness, while fostering collaboration with peers across relevant functional areas
Other duties as assigned
Qualifications
BS/BA degree AND 10+ years of relevant biotech/pharma/CRO clinical development experience
Master’s degree AND 8+ years of related biotech/pharma/CRO clinical development experience
PhD AND 5+ years of related biotech/pharma/CRO clinical development experience
Considered an expert within the company and may have external presence in area of expertise
Applies in-depth knowledge of own function, business/commercial/scientific expertise to solve critical issues successfully and innovatively
Ability to work as part of and lead multiple teams
Sees broader picture and longer-term impact on division/company
Excellent leadership, coaching and development skills
Strong negotiation and influencing skills
Excellent communication, problem-solving, analytical thinking skills
Excellent computer skills
Excellent organizational and time management skills with the ability to work independently and in a team environment to meet established deadlines
Deep knowledge of CDASH and CDISC industry standards (e.g., SDTM, ADaM, Define.xml) and the increasingly complex regulatory requirements for delivering regulatory quality data
Experience leveraging standards to create processes that facilitate automation and AI-driven solutions to optimize Analytic and Data Sciences deliverables
Advanced SAS or R proficiency; Python and SQL strongly preferred
Experience with Medidata Rave EDC build and content reuse (CRF standards, edit checks, libraries) and downstream readiness
Deep knowledge of GxP expectations, data integrity, audit trails, and partnering with IT/Quality on validation
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Responsibilities
Implement and champion continuous improvement of foundational standards that enable automation and consistent execution across studies (e.g., standards rulesets, mappings, reusable templates, workflow checklists, and controlled specifications)
Drive standards implementation and operationalization aligned to CDISC expectations, including linkage between CDASH-compliant data collection and downstream CDISC-compliant data and subsequent Neurocrine standard analysis/reporting
Support design and quality of submission-critical outputs, including the Define-XML package, ensuring traceability, consistency and an inspection-readiness mindset
Build and deploy low/no-code automations that improve standards adherence and consistency, handoff quality between Data Management, Statistical Programming and Biostatistics, repeatability of analysis and reporting workflows, inspection readiness through controlled outputs and documentation
Enable governed AI use within Biometrics (creating and implementing use cases, access restrictions, peer review, and automated checks)
Define inspection-ready evidence for automated/AI-assisted outputs
Provide training and technical support to end users for effective adoption and utilization of AI and automation solutions
Shape, with buy-in and endorsement from ADS Leaders, the ADS technology strategy by guiding the adoption of innovative technologies and encouraging a culture of creativity and continuous improvement
Drive innovation within biometrics by identifying and implementing new tools, technologies, and methodologies to enhance efficiency and effectiveness, while fostering collaboration with peers across relevant functional areas
Other duties as assigned
Qualifications
BS/BA degree AND 10+ years of relevant biotech/pharma/CRO clinical development experience
Master’s degree AND 8+ years of related biotech/pharma/CRO clinical development experience
PhD AND 5+ years of related biotech/pharma/CRO clinical development experience
Considered an expert within the company and may have external presence in area of expertise
Applies in-depth knowledge of own function, business/commercial/scientific expertise to solve critical issues successfully and innovatively
Ability to work as part of and lead multiple teams
Sees broader picture and longer-term impact on division/company
Excellent leadership, coaching and development skills
Strong negotiation and influencing skills
Excellent communication, problem-solving, analytical thinking skills
Excellent computer skills
Excellent organizational and time management skills with the ability to work independently and in a team environment to meet established deadlines
Deep knowledge of CDASH and CDISC industry standards (e.g., SDTM, ADaM, Define.xml) and the increasingly complex regulatory requirements for delivering regulatory quality data
Experience leveraging standards to create processes that facilitate automation and AI-driven solutions to optimize Analytic and Data Sciences deliverables
Advanced SAS or R proficiency; Python and SQL strongly preferred
Experience with Medidata Rave EDC build and content reuse (CRF standards, edit checks, libraries) and downstream readiness
Deep knowledge of GxP expectations, data integrity, audit trails, and partnering with IT/Quality on validation
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