Global Program Clinical Head - Rheumatology/Gastroenterology
Global Program Clinical Head - Rheumatology/Gastroenterology
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Job Description
Band
Level 7Job Description Summary
Leads the strategic planning execution and delivery of all global clinical trials across all programs within the assigned TA. Complete oversight of budget and resource allocation within the therapeutic area including enterprise review of resources across the TAs. Drives operational excellence through process improvement and knowledge sharing across the function. Develops an empowered organization which can navigate in a matrix environment and adjust quickly to business needs.Job Description
This hybrid role can be based in London Basel Dublin or Barcelona.
Major accountabilities:
Leads the GCT 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 (Proof of Concept) projects to Development Decision Point (DDP)
May support Business Development & Licensing (BD&L) activities Post-DDP leads the development and execution of the clinical strategy.
Develops an endorsed Integrated Development Plan (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
Leads the creation of clinical components of key documents (e.g. Clinical Trial Protocols (CTPs) Investigators Brochures Clinical Study Reports (CSRs) 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 (e.g. Core Data Sheet Periodic Safety Update Report clinical benefit-risk assessment for license renewals) for the compound(s)
Together with Patient Safety ensures continuous evaluation of 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 (e.g. regulatory authorities key opinion leaders data monitoring committees advisory boards patient advocacy groups) internal stakeholders (e.g. Research Translational Medicine Global Medical Affairs (GMA) Marketing Health Economics & Outcomes Research) and internal decision boards.
Minimum requirements:
What youll bring to the role:
MD or equivalent (preferred) PhD or PharmD degree required
6 years professional experience with (MD or equivalent) OR 10 years (PhD or PharmD) of involvement in clinical research or drug development in an industry environment spanning clinical activities in Phases I through III/IV including submission dossiers required
Immunology disease expertise ideally experience with Rheumatology / Gastroenterology
Advanced knowledge of assigned therapeutic area required 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 required
Experience with submissions and health authorities required
Demonstrated ability to establish strong scientific partnership with key stakeholders
Demonstrated leadership and management skills with a documented track record of delivering high quality projects/submissions/trials in a global/matrix environment (including remote) in pharmaceutical or biotech industry
Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.
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Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to all individuals. If because of a medical condition or disability you need a reasonable accommodation for any part of the recruitment process or in order to receive more detailed information about the essential functions of a position please send an e-mail to and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
#LI - hybrid
Skills Desired
Clinical Decision Making Clinical Research Clinical Trials Disease Area Knowledge Drug Development Leadership People Management Risk Management Strategy DevelopmentRequired Experience:
Exec
Employment Type
Full-Time
