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Sr. Director (Apps & Data Strategy)

Hybrid in South San Francisco, CA, US • Posted 18 hours ago • Updated 17 hours ago

Contract Independent

Contract W2

12 Months

Hybrid

$90 - $100/hr

Fitment

Dice Job Match Score™

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Job Details

Skills

Business Strategy
Clinical Trial Management System
GMP
Good Clinical Practice
GxP
Master Data Management
QMS
Quality Management
Regulatory Compliance
Roadmaps
Veeva
LIMS
Enterprise Resource Planning
Budget

Summary

Application Portfolio Scope

Primary Responsibility

Domain	Representative Systems	Regulatory Context
Clinical	eTMF, CTMS, EDC (Medidata/Veeva), IRT/RTSM, Safety/Pharmacovigilance (ArgOracle), eCOA/ePRO	ICH E6 (R2) Google Cloud Platform, 21 CFR Part 11, EU Annex 11
Quality	EQMS (Veeva Quality One / Master Control), LIMS, Batch Record (EBR/MBR), QMS, Deviation & CAPA, Change Control	21 CFR Part 11, ICH Q10, ISO 13485, EU GMP Annex 11
R&D / CMC	ELN (Lab Archives / Benchling), SDMS, Formulation & Stability, Assay Mgmt, Process Development platforms, Data Lake integrations	GLP, 21 CFR Part 58, ICH Q8/Q9

Good to Have

Experience with enterprise ERP platforms commonly deployed in biotech/pharma manufacturing environments, including but not limited to:

SAP S/4HANA or ECC (PP/PI, QM, PM, MM modules) with GMP-validated configuration
Oracle Cloud ERP, NetSuite, or Microsoft Dynamics 365 in a regulated manufacturing context
ERP-LIMS and ERP-MES integration patterns for batch release workflows
Material master governance, BOM management, and lot/serial traceability for ATMPs or biologics

Additional Scope (Beneficial)

Exposure to the following corporate application domains is a plus. These systems are managed in collaboration with HR, Finance, and Legal stakeholders:

People & Culture (P&C): Workday HCM, ADP, Lattice, Culture Amp, learning management systems (LMS)
HRMS / Payroll: Workday Payroll, Rippling, or equivalent platforms; SOX-relevant access controls
Legal & Compliance: Contract lifecycle management (Ironclad, Conga), IP management, board portals
Finance Apps: Workday Financials, Coupa, Concur; familiarity with SOX ITcontrols

Key Responsibilities

Strategy & Portfolio Governance

Own the enterprise application roadmap aligned to clinical program milestones, manufacturing scale-up, and regulatory filings (IND, BLA, MAA)
Define and maintain the application portfolio architecture, rationalizing redundant systems and managing total cost of ownership
Partner with the VP/CIO and functional leaders to translate business strategy into technology investment decisions
Establish and chair an Application Governance Council with stakeholder representatives from Clinical, Quality, R&D, and Manufacturing

GxP Systems & Validation

Serve as the senior IT accountability owner for all validated systems; ensure compliance with 21 CFR Part 11, EU Annex 11, ICH guidelines, and applicable GxP requirements
Lead computerized system validation (CSV) and computer software assurance (CSA) programs across the validated application estate
Oversee data integrity controls (audit trails, electronic signatures, access management) across Clinical, Quality, LIMS, and EBR/MBR systems
Maintain inspection readiness; serve as senior IT liaison during FDA, EMA, or Notified Body audits and due-diligence reviews
Drive the transition from traditional CSV to risk-based CSA approaches in alignment with FDA guidance

Implementation & Delivery

Lead end-to-end selection, implementation, and go-live of enterprise applications on time, within budget, and fully validated
Manage a portfolio of concurrent projects across Clinical, Quality, and R&D domains using structured project management disciplines
Oversee systems integrators, SaaS vendors, and implementation partners; negotiate contracts and ensure SLA adherence
Drive adoption through structured change management, super-user programs, and training in partnership with functional stakeholders

Team Leadership & Operating Model

Build, mentor, and retain a team of application managers, business analysts, and validation specialists across clinical, quality, and R&D domains
Define clear ownership and RACI for every application in the portfolio, including vendor-managed and cloud-hosted systems
Establish managed services models for application support; define incident, change, and release management processes
Foster a culture of continuous improvement, regulatory awareness, and cross-functional partnership

Data, Security & Architecture Standards

Partner with Data & Analytics on master data governance, clinical data standards (CDISC: CDASH, SDTM, ADaM), and FAIR data principles
Enforce application security standards, role-based access controls, and separation of duties in alignment with Cybersecurity and Compliance policies
Contribute to enterprise architecture decisions, API integration strategy, and cloud platform standards (AWS, Azure, Google Cloud Platform)

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: nexinfo
Position Id: 9003225
Posted 18 hours ago

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InfantSelvin Thomas

Recruiter @ NexInfo Solutions, Inc.

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