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Global Program Clinical Head
3 months ago
**Summary**:
**About the Role**:
Are you an experienced Drug Development Leader looking for an exceptional opportunity to make a global impact? Novartis is seeking a Global Program Clinical Head for In-market Brands to join our team in Switzerland. As a leader in the industry, Novartis is dedicated to discovering innovative solutions that improve patients' lives worldwide.
**Responsibilities**:
- Leading the GCT and representing Clinical Development on the Global Program Team (GPT)
- Leading the creation of clinical components of key documents (e.g., Clinical Trial Protocols (CTPs), Investigator’s Brochures, Clinical Study Reports (CSRs), regulatory documents including maintenance of product licenses, registration dossiers, value dossiers, pharmaco-economic dossiers) with high quality and consistency with Integrated Development Plan (IDP) and Target Product Profile (TPP). Supports registration, market access, commercialization, and maintenance of product licenses (e.g., Core Data Sheet, Periodic Safety Update Report, clinical benefit-risk assessment for license renewals) for the compound(s)
- May serve as the Clinical Development Representative on NIBR clinical/project teams to drive transition of pre-PoC (Proof of Concept) projects to Development Decision Point (DDP)
- Post-DDP, leading the development and execution of the clinical strategy. Developing an endorsed (IDP) in line with the Target Product Profile (TPP) which is designed for successful global regulatory approval/market access for one or multiple treatment indications and/or multiple programs
- Where applicable, supporting Business Development & Licensing (BD&L) activities
**Requirements**:
- MD, PhD, or PharmD degree required, specialization in a subspecialty preferred
- Minimum 10 years involvement in clinical research or drug development in an industry environment spanning clinical activities in Phases I through III/IV, including submission dossiers
- Sophisticated knowledge of assigned therapeutic area preferred, with the capability to innovate in clinical development study designs that provide relevant evidence to decision-makers, and to interpret, discuss and present clinical trial or section program level data
- Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development process
- Strong leadership skills with the ability to effectively collaborate and influence cross-functional teams
Division
Development
Business Unit
Innovative Medicines
Location
USA
Site
East Hanover
Company / Legal Entity
U014 (FCRS = US014) Novartis Pharmaceuticals Corporation
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No
