Sr. Director (Apps & Data Strategy)
Primary Responsibility
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.
Lead computerized system validation (CSV) and computer software assurance (CSA) programs across the validated application estate.
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.
Domain Represented
Domain: ClinicaleTMF, CTMS, EDC (Medidata/Veeva), IRT/RTSM, Safety/Pharmacovigilance (ArgOracle), ECOA/ePRO
Domain: GLP, 21 CFR Part 58, ICH Q8/Q9
Representative Systems
- Google Cloud Platform
- 21 CFR Part 11
- EU Annex 11
Regulatory Context
- 21 CFR Part 11
- ICH Q10
- ISO 13485
- EU GMP Annex 11
R&D / CME
- ELN (Lab Archives / Benchling)
- SDMS
- Formulation & Stability
- Assay Mgmt
- Process Development Platforms
- Data Lake Integrations
Quality
- EQMS (Veeva Quality One / Master Control)
- LIMS
- Batch Record (EBR/MBR)
- QMS
- Deviation & CAPA
- Change Control
Additional Scope (Beneficial)
- Exposure to the following corporate application domains is a plus:
- 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 IT controls
Key Responsibilities
- Strategy & Portfolio Governance
- Strategy & Portfolio Governance
- Strategy & Portfolio Governance
- Strategy & Portfolio Governance
- Strategy & Portfolio Governance
- Strategy & Portfolio Governance
- Strategy & Portfolio Governance
- Strategy & Portfolio Governance
- 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.
- 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).