Global Program Clinical Head

Overview

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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 and is accountable specifically for the clinical development strategy.

About the role:

the GPCH oversees immunology-focused clinical development, creating, implementing, and carrying out clinical development programs to support crucial decision-making, regulatory standards, and market access, while contributing to the overall strategy in immunology.

• Lead the Global Clinical Team(s) (GCT) and represent Clinical Development on the Global Program Team (GPT).
• May serve as the Clinical Development Representative on Novartis Institute for Biomedical Research (NI ) Translational Medicine/project teams to drive progress of early projects to Transition Decision Point (TDP), including developing the Clinical Development Plan (CDP).
• Post-TDP, lead the execution of the CDP and contribute to the Integrated Development Plan (IDP) generated by multiple line functions, in line with the Target Product Profile (TPP) designed for successful global regulatory approval and market access for one or multiple treatment indications and/or multiple programs.
• Lead the creation of clinical components of key documents (e.g., Clinical Trial Protocols, Investigator Brochures, Clinical Study Reports, regulatory documents including maintenance of product licenses, registration dossiers, value dossiers, pharmacoeconomic dossiers) with high quality and consistency with the CDP, IDP, and TPP. Support 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).
• Collaborate with Patient Safety to ensure continuous evaluation of the drug safety profile, including safety monitoring of clinical studies and signal detection from post-marketing surveillance; serve as a core member of the Safety Management Team.
• As the medical expert, lead interactions with external stakeholders (regulatory authorities, key opinion leaders, data monitoring committees, advisory boards, patient advocacy groups) and internal stakeholders (NI  Research, Translational Medicine, Medical Affairs, Commercial, Portfolio & Strategy, Health Economics & Outcomes Research), and internal decision boards.

• MD or equivalent (preferred), PhD, or Pharm
  
  D degree required; equivalent experience considered. Subspecialty specialization may be needed.
• Board certified in Immunological Specialty Area with 6 years (MD or equivalent) or 10 years (PhD or Pharm
  
  D) of involvement in clinical research or drug development in an industry environment, including Phases I–III/IV and submission dossiers.
• Strong global team leadership skills with ability to manage across time zones; based out of US headquarters in East Hanover, NJ or Basel, Switzerland.
• Advanced knowledge of the assigned therapeutic area with capability to innovate in clinical development study designs.
• 5 years of people management experience.
• Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development processes.
• Experience with submissions and health authorities required.

Novartis Compensation and Benefit

Summary:

The pay range for this position at commencement of employment is expected to be between: $261,100/year to $484,900/year; ranges may adjust during the period 1/1/25 through 12/31/25. Final pay determinations depend on location, experience, knowledge, skills, and abilities. The total compensation package may include a sign-on bonus, restricted stock units, discretionary awards, and a full…