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.
The GPCH owns the risk-benefit assessment for the program(s) and, as the leader of Global Clinical Team(s) (GCT), is accountable for the design, implementation, and execution of clinical development programs to support decision milestones, regulatory requirements, and market access. The GPCH may also contribute to disease area strategy.
About the Role
The role reports to the Clinical Development Head.
Your responsibilities will include:
1. Leading the GCT and representing Clinical Development on the Global Program Team (GPT).
2. Supporting the transition of pre-PoC projects to Development Decision Point (DDP) as the Clinical Development Representative on NIBR clinical/project teams.
3. Supporting Business Development & Licensing (BD&L) activities.
4. Post-Development Decision Point, leading the development and execution of the clinical strategy, including developing an endorsed Integrated Development Plan (IDP) aligned with the Target Product Profile (TPP) for global regulatory approval and market access.
5. Creating clinical components of key documents such as Clinical Trial Protocols (CTPs), Investigator’s Brochures, Clinical Study Reports (CSRs), and regulatory documents, ensuring high quality and consistency with IDP and TPP. Supporting registration, market access, and maintenance of product licenses.
6. Ensuring continuous evaluation of the drug safety profile, including safety monitoring and signal detection from post-marketing surveillance, as a core member of the Safety Management Team (SMT).
7. Leading interactions with external stakeholders (regulatory authorities, key opinion leaders, data monitoring committees, advisory boards, patient advocacy groups) and internal stakeholders (Research, Translational Medicine, Global Medical Affairs, Marketing, Health Economics & Outcomes Research), as well as internal decision boards.
Minimum Requirements:
* MD or equivalent (required); PhD (preferred).
* At least 5 years of professional experience as an MD and a minimum of 10 years in clinical drug development in industry, spanning Phases I through III/IV, with experience leading submission dossiers.
* Ideally, a Board-certified Nephrologist or extensive (>5 years) experience in clinical development within the Nephrology therapeutic area.
Additional qualifications include advanced knowledge of the assigned therapeutic area, ability to innovate in clinical study designs, thorough knowledge of GCP, clinical trial design, statistics, regulatory processes, and demonstrated leadership in a global/matrix environment.
Why Novartis: Helping people with disease and their families requires more than innovative science. It takes a community of passionate, collaborative people like you. Join us to create breakthroughs that change patients’ lives. Learn more at https://www.novartis.com/about/strategy/people-and-culture
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