- Leading the GCT and representing Clinical Development on the Global Program Team (GPT)
- Leading the creation of clinical components of key documents (e.g., Clinical Trial Protocols (CTPs), Investigator's Brochures, Clinical Study Reports (CSRs), regulatory documents including maintenance of product licenses, registration dossiers, value dossiers, pharmaco-economic dossiers) with high quality and consistency with Integrated Development Plan (IDP) and Target Product Profile (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)
- May serve as the Clinical Development Representative on NIBR clinical/project teams to drive transition of pre-PoC (Proof of Concept) projects to Development Decision Point (DDP)
- Post-DDP, leading the development and execution of the clinical strategy. Developing an endorsed (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
- Where applicable, supporting Business Development & Licensing (BD&L) activities
- Novartis: e-mail [email protected] or call
- Sandoz: e-mail [email protected] or call:
- MD or equivalent (preferred), PhD, or PharmD degree required, specialization in a subspecialty may be needed.
- 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
- Advanced knowledge of assigned therapeutic area preferred, 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
- 5 years people management experience required; this may include management in a matrix environment
- Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development process
- Experience with submissions and health authorities required.
- Final job title (Senior GPCH, Band 2 / GPCH, Band 2) and associated responsibilities will be commensurate with the successful candidates' level of expertise.
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Global Program Clinical Head - East Hanover, United States - Novartis AG
Description
About the Role13 The number of medicines Cardio Renal Metabolic (CRM) diseases currently in development at Novartis.
Novartis is deeply committed to transforming the lives of people living with cardiovascular, renal and metabolic diseases.
We believe that anyone living with these conditions has the right to a life free from pain, free from symptoms and free from disease - this is our vision for the future.
Our mission is to reimagine medicine to extend and improve people's lives - and our overall company strategy to achieve this is to Focus Novartis as a leading medicine company powered by data science and advanced therapy platforms
The (Sr)* 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).
Your responsibilities include, but are not limited to:
We 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.
Accessibility and Reasonable Accommodations:
Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:
Why Novartis:
Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world.
How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions.Be a part of this mission and join us Learn more here:
You'll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
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.Novartis Compensation and Benefit Summary:
The pay range for this position at commencement of employment is expected to be between $257,600 - $386,400/year; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period.
Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities.
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.
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the N
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?
