Global Program Clinical Head, Oncology (MD)
Global Program Clinical Head, Oncology (MD)
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$ 261100 - 484900
1 Vacancy
Job Description
Job Description Summary
As the Senior Global Program Clinical Head (GPCH) you are the clinical lead and will serve as a key member of the Global Program Team contributing to the overall strategy in collaboration with relevant other functions such as Regulatory Affairs Market Access and others. You will develop and ensuring the implementation of the Clinical Development plan and leading a cross functional team of specialists such as Medical Directors Trial Directors Safety Leaders Biostatisticians and Regulatory addition you will lead the development and execution of the disease area strategy.Job Description
Your Key Responsibilities:
Responsible for clinical input to support Business Development & Licensing (BD&L) activities
Serve as the Clinical Development Representative to drive transition of pre-PoC (Proof of Concept) projects to Development Decision Point (DDP)
Contribute to 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 more treatment indications and/or multiple programs.
Drive creation and implementation of Clinical Development to support decision analysis and optimal resource allocation in program(s).
Lead a cross functional team through the creation of clinical components of key documents (e.g. Clinical Trial Protocols Investigators Brochures Clinical Study Reports regulatory documents including maintenance of product licenses registration dossiers value dossiers pharmacoeconomic dossiers) with high quality and consistency.
As the medical expert lead 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 Marketing Health Economics & Outcomes Research) and internal decision boards.
Together with Patient Safety ensure continuous evaluation of drug safety profile including safety monitoring of clinical studies and signal detection from post-marketing surveillance.
Support 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)
Plan and implement publication and clinical communication strategy in coordination with Global Medical Affairs and Medical Writing and provide input into key external presentations.
The ideal location for this role is the East Hanover site but remote work may be possible (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. If associate is remote all home office expenses and any travel/lodging to East Hanover for periodic live meetings will be at the employees expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require X% travel.
Video Link Requirements:
Essential Requirements:
MD with 6 years experience in clinical research or drug development in an industry environment spanning clinical activities in Phases I-III/IV including submission dossiers.
A passion for Oncology
Advanced expertise in Oncology with ability to innovate in clinical development study designs provide relevant evidence to decision-makers and to interpret discuss and present clinical trial or section program level data
Detailed 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 documented track record of delivering high quality projects/submissions/trials in a global/matrix environment (including remote) in pharmaceutical or biotech industry
Novartis Compensation and Benefit Summary:
The salary for this position is expected to range between $261100 and $484900 per year per year.
The final salary offered is determined based on factors like but not limited to relevant skills and experience and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and depending on the level of the role eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health life and disability benefits a 401(k) with company contribution and match and a variety of other addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves.
Why Novartis:
Our purpose is to reimagine medicine to improve and extend peoples 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: receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
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 Novartis Network here: Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion sex national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status.
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 to perform the essential functions of a position please send an e-mail to or call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$261100.00 - $484900.00Skills 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
