Therapeutic Data Strategy Director
Novartis
Therapeutic Data Strategy Director
Job Description
Summary
Summary • 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, , mitigated, and captured in the appropriate knowledge database. In collaboration with the GPT, GCT, and CTT, 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. This role creates and implements strategies for the end-to-end data product, ensuring application of Novartis clinical data standards and defining the clinical data acquisition and data review, strategy to support the submission of our clinical programs. The TDSD is responsible for ensuring that delivery and timelines are met with quality, whilst ensuring cost efficiencies and stakeholders’ satisfaction.Locations
- Mumbai (Office), India
Salary
Estimated Salary Rangemedium confidence
80,000 - 135,000 INR / yearly
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Clinical data strategy developmentintermediate
- Data regulatory complianceintermediate
- End-to-End (E2E) standards implementationintermediate
- Instruments and devices managementintermediate
- Quality by design (QbD)intermediate
- Stakeholder collaboration (GPT, GCT, CTT)intermediate
- Project management and timeline controlintermediate
- Cost efficiency optimizationintermediate
- Data acquisition and review strategyintermediate
- Leadership and team guidanceintermediate
- Issue identification and resolutionintermediate
- Contingency planningintermediate
Required Qualifications
- Extensive experience in clinical data strategy in pharmaceutical industry (experience)
- Deep knowledge of Novartis clinical data standards (experience)
- Experience in drug development lifecycle (experience)
- Strong background in therapeutic area operations (experience)
Responsibilities
- Define how clinical data strategy is operationalized across complete data flow within GCO
- Ensure data regulatory compliance
- Guarantee availability of End-to-End (E2E) standards
- Finalize instruments and devices prior to database build
- Align with GPT, GCT, and CTT on fit-for-purpose data package at program/indication level
- Create and implement end-to-end data product strategies
- Apply Novartis clinical data standards
- Define clinical data acquisition and data review strategy for program submissions
- Ensure delivery timelines are met with quality and cost efficiencies
- Manage stakeholder satisfaction
Answer 10 quick questions to check your fit for Therapeutic Data Strategy Director @ Novartis.
10 Questions
~2 Minutes
Instant Score
Therapeutic Data Strategy Director
Novartis
Therapeutic Data Strategy Director
Job Description
Summary
Summary • 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, , mitigated, and captured in the appropriate knowledge database. In collaboration with the GPT, GCT, and CTT, 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. This role creates and implements strategies for the end-to-end data product, ensuring application of Novartis clinical data standards and defining the clinical data acquisition and data review, strategy to support the submission of our clinical programs. The TDSD is responsible for ensuring that delivery and timelines are met with quality, whilst ensuring cost efficiencies and stakeholders’ satisfaction.Locations
- Mumbai (Office), India
Salary
Estimated Salary Rangemedium confidence
80,000 - 135,000 INR / yearly
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Clinical data strategy developmentintermediate
- Data regulatory complianceintermediate
- End-to-End (E2E) standards implementationintermediate
- Instruments and devices managementintermediate
- Quality by design (QbD)intermediate
- Stakeholder collaboration (GPT, GCT, CTT)intermediate
- Project management and timeline controlintermediate
- Cost efficiency optimizationintermediate
- Data acquisition and review strategyintermediate
- Leadership and team guidanceintermediate
- Issue identification and resolutionintermediate
- Contingency planningintermediate
Required Qualifications
- Extensive experience in clinical data strategy in pharmaceutical industry (experience)
- Deep knowledge of Novartis clinical data standards (experience)
- Experience in drug development lifecycle (experience)
- Strong background in therapeutic area operations (experience)
Responsibilities
- Define how clinical data strategy is operationalized across complete data flow within GCO
- Ensure data regulatory compliance
- Guarantee availability of End-to-End (E2E) standards
- Finalize instruments and devices prior to database build
- Align with GPT, GCT, and CTT on fit-for-purpose data package at program/indication level
- Create and implement end-to-end data product strategies
- Apply Novartis clinical data standards
- Define clinical data acquisition and data review strategy for program submissions
- Ensure delivery timelines are met with quality and cost efficiencies
- Manage stakeholder satisfaction
Answer 10 quick questions to check your fit for Therapeutic Data Strategy Director @ Novartis.
10 Questions
~2 Minutes
Instant Score