Nov 11, 2022

Job Description

22! the number of oncology drugs we have on the market and more than 25 new molecular entities in development targeting key molecular pathways in cancer biology.
The Global Program Clinical Head (GPCH) is the global clinical leader responsible for one or more clinical programs across indications, involving one or multiple compounds.
As the leader of Global Clinical Team(s) (GCT), the GPCH is accountable for the design, implementation, and execution of a clinical development program(s) to support decision milestones, regulatory requirements, market access and owns the risk benefit-assessment for the program(s). The GCPH contributes to the disease area strategy.
Your responsibilities include, but are not limited to:
• 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

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

• MD or equivalent (preferred), PhD, or PharmD degree required, specialization in Hematology or Oncology. Advanced training/knowledge in CAR-T and clinical experience preferred
• 10 years (PhD or PharmD) of involvement in clinical research or drug development in an industry environment spanning clinical activities in Phases I through III/IV, including submission dossiers
• Advanced 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 and results
• 5 years people management experience required; this may include management in a matrix environment
• Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development process
• Experience with submissions and health authorities required.

*Some restrictions to flexible working models may apply and will be discussed at interview if applicable
Global Drug Development
Research & Development
Full Time
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Global Program Clinical Head , Hematology CAR-T **80-100%

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