Overview

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 a clinical development program to support decision milestones, regulatory requirements and market access. The GPCH may contribute to disease area strategy. This is a hybrid role based in London.

Responsibilities

• Leads the Global Clinical Team (GCT) and represents Clinical Development on the Global Program Team (GPT).
• May serve as the Clinical Development Representative on Biomedical Research clinical/project teams to drive transition of pre-PoC projects to Development Decision Point (DDP).
• May support Business Development & Licensing (BD&L) activities.
• Post-Development Decision Point, leads the development and execution of the clinical strategy. Develops an endorsed Integrated Development Plan (IDP) aligned with the Target Product Profile (TPP) for global regulatory approval and market access for one or multiple indications or programs.
• Leads the creation of clinical components of key documents (e.g., Clinical Trial Protocols, Investigator’s Brochures, Clinical Study Reports, regulatory documents including maintenance of product licenses, registration dossiers, value dossiers, pharmacoeconomic dossiers) with high quality and consistency with IDP and TPP. Supports registration, market access, commercialization, and maintenance of product licenses for the compound(s).
• Together with Patient Safety, ensures continuous evaluation of the drug safety profile, including safety monitoring of clinical studies and signal detection from post-marketing surveillance. Serves as a core member of the Safety Management Team (SMT).
• As the medical expert, leads interactions with external stakeholders (regulatory authorities, key opinion leaders, data monitoring committees, advisory boards, patient advocacy groups) and with internal stakeholders (Research, Translational Medicine, Global Medical Affairs, Marketing, Health Economics & Outcomes Research). Represents the program on internal decision boards.

Minimum Requirements

• MD or equivalent (required); PhD (preferred).
• 5 years professional experience as an MD and a minimum of 10 years of experience with clinical drug development in an industry environment spanning Phases I–III/IV, including experience with leading submission dossiers (required).
• Ideally Board-certified Oncologist or extensive (>5 years) experience in clinical development within Oncology.
• Advanced knowledge of the assigned therapeutic area, with the capability to innovate in clinical development study designs and to interpret, discuss, and present trial or program-level data.
• Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development process.
• Demonstrated ability to establish strong scientific partnership with key stakeholders.
• Demonstrated leadership and management skills with a track record of delivering high-quality projects/submissions/trials in a global/matrix environment (including remote) in pharmaceutical or biotech industry.

Additional Information

This is a hybrid role based in London. Accessibility and accommodation: Novartis is committed to providing reasonable accommodation for applicants with disabilities. If you need accommodation during the recruitment process, please email diversity.inclusion_ch@novartis.com with your request and contact information, including the job requisition number.

Company Information

Why Novartis: Novartis is focused on building an outstanding, inclusive work environment and diverse teams representing the patients and communities we serve.

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London, England, United Kingdom