Novartis
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Therapeutic Data Strategy Director
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Novartis The ideal location for this role is East Hanover, NJ but remote work may be possible (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. If associate is remote, all home office expenses and any travel/lodging to East Hanover, NJ site for periodic live meetings will be at the employee’s expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require limited travel. The Therapeutic Data Strategy Director (TDSD) bridges science and operations by defining how the clinical data strategy is operationalized across the complete data flow within GCO. The TDSD is responsible for ensuring data regulatory compliance, the availability of End-to-End (E2E) standards, that instruments and devices are thoroughly discussed, defined, and finalized prior to the database build and that the operational impact of any new changes are known, costed, mitigated, and captured in the appropriate knowledge database. In collaboration with the GPT, the TDSD aligns on the 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 (TA) within an assigned unit in Novartis. Key Responsibilities
Operational Execution of the Program Strategy: 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 understand 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.) 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 Requirements
Minimum: Bachelor’s degree in life sciences, preferably with a statistics module A minimum of 15 years in a R&D regulated environment in a relevant pharmaceutical or health care company Excellent understanding of end-to-end clinical data processing and the clinical trial operations space 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 Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $168,000/yr and $312,000/yr; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits. Details of participation in these plans will be provided if an offer is extended. This is an at-will position and the Company reserves the right to modify base salary and other compensation programs at any time, including for reasons related to performance or market factors. EEO Statement The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to providing reasonable accommodation to individuals with disabilities. If you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position, please email us with the job requisition number and your contact information.
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Therapeutic Data Strategy Director
role at
Novartis The ideal location for this role is East Hanover, NJ but remote work may be possible (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. If associate is remote, all home office expenses and any travel/lodging to East Hanover, NJ site for periodic live meetings will be at the employee’s expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require limited travel. The Therapeutic Data Strategy Director (TDSD) bridges science and operations by defining how the clinical data strategy is operationalized across the complete data flow within GCO. The TDSD is responsible for ensuring data regulatory compliance, the availability of End-to-End (E2E) standards, that instruments and devices are thoroughly discussed, defined, and finalized prior to the database build and that the operational impact of any new changes are known, costed, mitigated, and captured in the appropriate knowledge database. In collaboration with the GPT, the TDSD aligns on the 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 (TA) within an assigned unit in Novartis. Key Responsibilities
Operational Execution of the Program Strategy: 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 understand 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.) 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 Requirements
Minimum: Bachelor’s degree in life sciences, preferably with a statistics module A minimum of 15 years in a R&D regulated environment in a relevant pharmaceutical or health care company Excellent understanding of end-to-end clinical data processing and the clinical trial operations space 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 Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $168,000/yr and $312,000/yr; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits. Details of participation in these plans will be provided if an offer is extended. This is an at-will position and the Company reserves the right to modify base salary and other compensation programs at any time, including for reasons related to performance or market factors. EEO Statement The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to providing reasonable accommodation to individuals with disabilities. If you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position, please email us with the job requisition number and your contact information.
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