Global Program Clinical Head - Rheumatology
- East Hanover, New Jersey, United States
- Closing date
- Mar 28, 2023
10! That’s how many pipeline projects Immunology has in Phase 3 or registration and over 25 projects in Phase 1/2. Our Immunology Unit has a pipeline with depth and breadth and is known to be a talent powerhouse. We are uniquely positioned to have a critical impact on bringing innovative medicines to patients across multiple disease areas.
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.
Your responsibilities will include:
•Leads the GCT, represents Clinical Development on the Global Program Team (GPT)
•May serve as the Clinical Development Representative on Novartis Institute for Biomedical Research (NIBR) Translational Medicine/project teams to drive progress of early projects to Transition Decision Point (TDP), including developing the Clinical Development Plan (CDP)
•May support Business Development activities
•Post-TDP, leads the execution of the CDP and contributes 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
•Leads 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. 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
•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., NIBR Research, Translational Medicine, Medical Affairs, Commercial, Health Economics & Outcomes Research), and internal decision boards
Diversity & Inclusion / EEO
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
What you’ll bring to the role:
•MD or equivalent with specialty in Rheumatology (preferred) or Immunology
•6 years professional experience (with MD or equivalent) in clinical research or drug development, in an industry environment spanning clinical activities in Phases I through III/IV, including submission dossiers (required)
•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 program-level data
•Thorough knowledge of Good Clinical Practice, clinical trial design, statistical analysis methodology, and regulatory/clinical development processes 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 remotely based associates) in the pharmaceutical or biotechnology industry
** Some restrictions to flexible working models may apply and will be discussed at interview if applicable
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Accessibility and Reasonable Accommodations: The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
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