Main Responsibilities Include
- Partner with clinical development to ensure seamless clinical data flow and study execution across therapeutic areas.
- Lead AI-powered clinical data processing strategy and roadmap for AI-enabled clinical data flows; optimize processes to improve efficiency and data quality.
- Enable real-time access to clinical data from diversified sources; enhance data quality and intelligence generation.
- Establish governance for system validation, change management, quality assurance, and regulatory compliance; standardize clinical database design aligned with CDISC (SDTM/ADaM/CDASH).
- Build partnerships with technology providers, CROs, and academic institutions to enable real-time eHR and patient-generated data (wearables/mobile health).
- Ensure data interoperability/integration across traditional and novel data sources.
- Define and execute business strategy and sourcing strategy for digital transformation; represent CDAIP in enterprise planning.
- Lead/mentor teams; drive innovation and cross-functional collaboration.
- Partner with Clinical Operations, Digital, EGDS, Regulatory, and Vaccine teams to integrate AI/data solutions into workflows.
- Ensure AI/data processing activities comply with relevant regulations and maintain data governance, privacy, security, and risk management.
Basic Qualifications
- Masterโs/PhD in Life Sciences, CS, Data Science, Biostatistics (or Bachelorโs with extensive leadership experience).
- 10+ years in progressive leadership roles across clinical development, data management/biostatistics/AI.
- Deep expertise in clinical data management/analytics across lifecycle.
- Strong CDISC knowledge (SDTM, ADaM, CDASH) and clinical trial/regulatory (FDA/EMA/ICH-GCP) requirements.
- Proven transformational leadership in global, complex organizations.
Benefits (as stated)
- Rewards package; healthcare and wellbeing benefits; at least 14 weeksโ gender-neutral parental leave.