Novartis · 1 month ago
Therapeutic Data Strategy Director
East Hanover, NJ
Full-time
Hybrid
Director/Executive
$168K/yr - $312K/yr
15+ years expNovartis is a leading pharmaceutical company dedicated to helping people with diseases and their families. The Therapeutic Data Strategy Director is responsible for bridging science and operations by defining and operationalizing the clinical data strategy across the complete data flow within GCO, ensuring regulatory compliance and quality in data management.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
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.)
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
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
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
Qualification
Required
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
Benefits
Sign-on bonus
Restricted stock units
Discretionary awards
Full range of medical, financial, and/or other benefits
401(k) eligibility
Various paid time off benefits, such as vacation, sick time, and parental leave
Company
Novartis
Novartis is a pharmaceutical company that researches and develops medicines for serious diseases to improve and extend people's lives.
10001+ employees
H1B Sponsorship
Novartis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (27)
2023 (23)
2022 (27)
2021 (31)
2020 (25)
Funding
Current Stage
Public CompanyTotal Funding
$2.49BKey Investors
Bill & Melinda Gates Foundation
2024-06-19Post Ipo Debt· $2.49B
2018-02-14Grant· $6.5M
2000-05-19IPO
Leadership Team
Daniel Grant
Vice President & Global Program Head
John von Brachel
VP, Head of Content Lab
Recent News
2026-01-23
2026-01-23
Company data provided by crunchbase