Global Program Clinical Head
vor 7 Monaten
393119BR
**Global Program Clinical Head - Neurosciences**:
Switzerland
**About the role**
With more than 60-year history in neuroscience, Novartis brought landmark therapies to patients with Multiple Sclerosis, Alzheimer’s disease, Parkinson’s Disease, Epilepsy, Depression and Migraine. We have an extraordinary pipeline in neuro-inflammation, neuro-degeneration and neuromuscular diseases. Our integrated R&D approach includes groundbreaking molecules, comprehensive approaches to technology, biomarker and digital therapeutics to propose better solutions for patients worldwide. This position is focused on Multiple Sclerosis to support and develop our branded compounds in MS as the global clinical leader.
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.
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
**Commitment to Diversity & Inclusion**:
- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Role Requirements**
Minimum requirements:
MD or equivalent (preferred), PhD, or PharmD degree required, specialization in a subspecialty may be needed.
Advanced clinical training/knowledge in Neurosciences (MD or equivalent)
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
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.
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
**Division**
Development
**Business Unit**
CLINICAL DEVELOPMENT DEV
**Work Location**
Basel
**Company/Legal Entity**
Novartis Pharma AG
**Functional Area**
Research & Development
**Job Type**
Full Time
**Employment Type**
Regular
**Shift Work**
No
**Early Talent**
No
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