- Leading the GCT and representing 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, 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
- MD or equivalent with specialization and board-certification in Rheumatology
- 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)
- 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
- 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 and program-level data
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Global Program Clinical Head - East Hanover, United States - Novartis AG
Description
About the Role
The ideal location for this role is East Hanover, NJ, but remote work may be possible (there may be restrictions based on legal entity).
If the associate is remote, all home office expenses and travel/lodging to the East Hanover or corporate site for periodic live meetings will be at the employee's expense.
The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager.
10-that's how many pipeline projects Immunology has in Phase 3 or registration\\, with over 25 projects in Phase 1 or 2 Novartis' Immunology Unit has a pipeline with both depth and breadth and is known to be a talent powerhouse.
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 as GPCH will include the following:
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.
Role RequirementsWhat you'll bring to the role:
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.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility.
And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges.
Because the greatest risk in life, is the risk of never tryingImagine what you could do here at Novartis
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 and let us know the nature of your request and your contact information.
Please include the job requisition number in your message.
The pay range for this position at commencement of employment is expected to be between $284,000-$486,000 a year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.
The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered.
Details of participation in these benefit plans will be provided if an employee receives an offer of employment.If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?
