Job Description

Band

Level 6

Job Description Summary

This position will be located at East Hanover NJ site and will not have the ability to be located remotely.
Please note that this role would not provide relocation and only local candidates will be considered.

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 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.

#LI-Onsite

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 teams 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.).

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.

Job Description

Requirements:

• Minimum: Bachelors 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. Strongly Preferred
• 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 $168000yr and $312000/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. Further final pay determinations will depend on various factors including but not limited to geographical location experience level knowledge skills and abilities. 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 (including 401(k) eligibility and various paid time off benefits such as vacation sick time and parental leave) dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and 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 gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an e-mail to call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Range $168000.00 - $312000.00

Skills Desired

Clinical Trials Data Architecture Data Governance Data Integration Data Management Data Products Data Quality Data Science Data Strategy Drug Development Global Project Management Operations People Management

Required Experience:

Director

Job Tags

Full time, Local area, Remote work, Relocation, Relocation package,

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