Therapeutic Data Strategy Director

Role Summary

The Therapeutic Data Strategy Director (TDSD) defines how the clinical data strategy is operationalized across the full data flow within GCO, ensuring data regulatory compliance and end-to-end data standards. The role ensures instruments and devices are defined before database builds and that the operational impact of any changes is understood, costed, mitigated, and captured in the appropriate knowledge database. In collaboration with the GPT, the TDSD aligns on fit-for-purpose data package as part of a program/indication level quality by design to support data strategy needs in the drug development lifecycle of a molecule or across therapeutic area within an assigned unit in Novartis.

Responsibilities

• Lead, establish and maintain a data strategy for the design, collection, processing, transformation, reporting and submission of clinical data
• Cost and impact assessment of proposed data collection, analysis, and reporting
• Drive capability inputs to data team’s resource algorithm based on future incoming demands
• Matrix data operations leader who is the single focal point for the sustained industry leading cycle time for data product
• Ensures the provision of resource with the skillset to develop robust & lean E2E specification during the initial set up stage
• Leads the full spectrum of standard development and compliance across their portfolio
• Consults to drive quality into the study protocol and operational processes
• Driving implementation of a lean global data strategy and define fit for purpose data requirements
• Ensure the fit for purpose data requirements remain intact and understanding the operational impact e.g., cost, resources, and time of any amendments as well as work with clinical development, analytics, and regulatory line functions to understand the scientific, clinical, statistical and regulatory impacts
• Support assessment on opportunity to capitalize on non-traditional options (e.g., historical data, synthetic data, cross-sponsor shared control arms IMI EU-PEARL, adaptive designs, pragmatic trials, decentralization, etc.)
• Work with Clinical Operational Program Head (COPH) and Vendor Program Manager (VPM) to define the provision of ancillary data, including vendor capabilities
• Author the Clinical Data Section of Operational Execution Plan (OEP) (key customers, dataflow, and targets to generate Data-as-a-Product (DaaP) etc.)

Responsibilities (continued)

• End-to-End Ownership Of The Clinical Data Flow
• Drives implementation of a lean global data strategy and defines fit for purpose data quality requirements sufficient to support good decision making and meet regulatory requirements
• Collaborates cross-functionally to define quality by design review process to ensure fit for purpose data quality sufficient to support good decision making
• Drives standards and processes to facilitate data right the first time

• End-to-End Standards Oversight & Lifecycle Management
• Responsible for compliance with data requirements and the availability of end-to-end clinical data standards (data collection through analysis) for a program/molecule/indication
• Influence and support the design of new clinical data standards as required at the enterprise/therapeutic area level
• Final governance decision maker for adoption and maintenance of data standards
• Drives/defines program level vendor data transfer specifications

• Operational Project Management
• Develop, communicate, and drive implementation of a global data operationalization strategy to deliver value-adding data; TDSD supports and guides the Data Team (as part of the CTT) in ensuring the overall program/OEP strategy is aligned with execution
• Establish key customers of Clinical Data and establish approach for future consumption
• Works with the business to ensure adherence to timelines, adoption of the data strategy and delivery of the target data product quality
• Influencer and interlocutor for adoption and compliance on business process and objectives related program data strategy
• Assesses / approves changes that impact the data collection, analysis and reporting strategy

Qualifications

• Required: A minimum of 15 years in a R&D regulated environment in a relevant pharmaceutical or health care company
• Preferred: Excellent understanding of end-to-end clinical data processing and the clinical trial operations space
• Preferred: Extensive knowledge and experience in ICH-GCP Process Control or ICH-GCP Quality Assurance systems and Health Authority regulations; Clinical Operations experience in these areas is preferred

Education

• Bachelor’s degree in life sciences, preferably with a statistics module

Additional Requirements

• Travel: Limited travel