Summary
About the Role
Job Description
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
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
