About The Role

Job Description Summary

-Accountable for managing all Data Mgmt / CDDRA deliverables for one or more assigned projects. Direct, oversee and coordinate all activities, deliverables and manage optimal use of resources within respective group or disease area. This is a key leader position ensuring that pharmaceutical drug-development plans in Novartis Global Drug Development are executed efficiently with timely and high quality deleiverables. It is a leader role with a strong understanding of the drug development process with a track record of agile/lean process development and training strategy and delivery for end-to-end deliverables in data Mgmt and statistical programming. Follows and oversees Good Clinical Practices (GCP), data-handling procedures and guidelines, reporting and tracking relevant business measures/metrics; organizational budget Mgmt; resource Mgmt and vendor Mgmt. Work seamlessly with partner groups. Lead, contribute to and implement initiatives to establish and maintain Novartis Data Mgmt as best in class in the industry. Leads and manages the review of clinical research protocols, reports and statistical analysis plans.Lead DO in all sponsor related Audits and inspections. -Responsible for assessing and ensuring data and programming quality, process adherence, appropriate documentation, system compliance, Facilitate sharing of resources between groups inorder to meet company goals and objectives.

Job Description

Major accountabilities

Lead and continuously enhance the CDO NDP governance framework, driving effective decision-making, prioritization, and alignment across CDO, GCO, GDD, and enterprise stakeholders.
Own the end-to-end NDP portfolio strategy and execution, ensuring initiatives are prioritized, accelerated, and deliver measurable business value and ROI.
Drive enterprise-wide cross-functional alignment for strategic initiatives through proactive stakeholder engagement, governance, risk management, and issue resolution.
Translate strategic priorities into operational plans, partnering with the Director of Operations and CDOLT to align goals, resources, and execution across sub-functions.
Lead governance forums and executive reviews (QRBs, PRMs, CDOLT engagements), ensuring structured decision-making, escalation of risks, and accountability for outcomes.
Sponsor and deliver transformation, quality, and operational excellence initiatives, including continuous improvement, inspection readiness, and capability enhancement programs.
Enable data-driven leadership decisions through integrated reporting, advanced analytics, KPI/OKR frameworks, dashboards, predictive insights, and business performance monitoring.
Lead enterprise communication and change management efforts, ensuring consistent messaging, organizational engagement, and alignment with CDO/GCO strategic priorities.
Oversee vendor and resource management at scale, including FSP governance, demand forecasting, capacity planning, performance management, SLA compliance, and risk mitigation.
Drive operational efficiency, team effectiveness, and talent development through process optimization, cost management, cross-functional collaboration, succession planning, and capability building.

Minimum Requirements

Bachelor’s or advanced degree in Life Sciences, Pharmacy, Nursing, Computer Science, or a related discipline, with strong business and operational acumen.
12+ years of experience in Drug Development, including 8+ years within Clinical Data Operations or related clinical development functions, with a proven track record of leading complex, global initiatives.
Demonstrated expertise in stakeholder management, negotiation, and influencing, with the ability to drive alignment and outcomes across senior leaders, cross-functional teams, and external partners.
Strong understanding of clinical trial methodologies, GCP (Good Clinical Practice), regulatory requirements, and clinical development processes, enabling effective governance and risk management.
Proven leadership experience in driving transformation, operational excellence, portfolio governance, and organizational change, including the successful delivery of cross-functional strategic programs.
Exceptional communication, collaboration, and problem-solving skills, with the ability to anticipate risks, operate effectively in a global matrix environment, and lead teams through complexity and change.

Skills Desired

Clinical Data Management, Data Architecture Development, Data Governance, Data Management, Data Quality, Data Science, Drug Development, Master Data, People Management, Waterfall Model