Global Program Clinical Head

Role Summary

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.

Responsibilities

• Leading the GCT and representing Clinical Development on the Global Program Team (GPT)
• May serve as the Clinical Development Representative on NIBR Translational Medicine/project teams to drive progress of early projects to Transition Decision Point (TDP), including developing the Clinical Development Plan (CDP)
• Post-TDP, leading the execution of the CDP and contributing to the Integrated Development Plan (IDP) generated by multiple line functions, 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
• Leading 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 consistent with the CDP, IDP, and TPP. Supporting 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)
• Together with Patient Safety, ensuring continuous evaluation of the drug safety profile, including safety monitoring of clinical studies and signal detection from post-marketing surveillance; serving as a core member of the Safety Management Team
• As the medical expert, leading interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring committees, advisory boards, patient advocacy groups), internal stakeholders (e.g., NIBR Research, Translational Medicine, Medical Affairs, Commercial, Portfolio & Strategy, Health Economics & Outcomes Research), and internal decision boards

Qualifications

• MD or equivalent (preferred), PhD, or PharmD degree required, with equivalent experience also considered. Specialization in a subspecialty may be needed.
• Board certified in Immunological Specialty Area with 6 years (MD or equivalent) or equivalent experience, 10 years (PhD or PharmD) or equivalent experience of involvement in clinical research or drug development in an industry environment spanning clinical activities in Phases I through III/IV, including submission dossiers.
• Strong Global team leadership skills and a capacity to work effectively and manage reports across time zones, while based out of our US headquarters in East Hanover, NJ or Basel, Switzerland
• Advanced knowledge of assigned therapeutic area required, with the capability to innovate in clinical development study designs
• 5 years of people management experience required
• Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development process
• Experience with submissions and health authorities required