Band
Level 7
Job Description Summary
Onsite
#LIOnsite
East Hanover New Jersey
About the role:
With over 60 years history in neuroscience Novartis brought landmark therapies to patients with Multiple Sclerosis Alzheimers disease Parkinsons Disease Epilepsy Depression and Migraine. We have a worldclass pipeline in neuroinflammation neurodegeneration psychiatric and neuromuscular diseases. Our holistic R&D approach includes cutting edge molecules comprehensive approaches to technology biomarker and digital therapeutics to propose better solutions for patients worldwide.
As Global Program Clinical Head (GPCH) you are the clinical lead for Neuroscience leading clinical development and contributing to overall strategy in collaboration with other functions to ensure the development and implementation of the Clinical Development plan. You will lead a crossfunctional team of specialists and align early development plans with the overall strategy oversee licensing evaluations and develop and execute 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 prePoC (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 postmarketing surveillance.
- Support registration market access commercialization and maintenance of product licenses (e.g. Core Data Sheet Periodic Safety Update Report clinical benefitrisk 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
Video Link position will be located at the East Hanover New Jersey site and will not have the ability to be located remotely. This position will require 5 travel as defined by the business (domestic and/ or international).
Role Requirements:
Essential Requirements:
- MD or PH. D degree with 10 years experience in clinical research or drug development in an industry environment spanning clinical activities in Phases IIII/IV including submission dossiers.
- A passion for Neuroscience
- Advanced expertise in Neuroscience with ability to innovate in clinical development study designs provide relevant evidence to decisionmakers 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
Desired Requirements:
- MD or equivalent MD or MD/PhD in Neurology Experience in Cell & Gene Rare or Neuromuscular diseases Neuroinflammation of interest
Novartis Compensation and Benefit Summary:
The pay range for this position at commencement of employment is expected to be between: $261100 and $484900/year; however while salary ranges are effective from 1/1/25 through 12/31/25 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 signon 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 atwill 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:
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.
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 email to calland let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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 gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. 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
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 email to calland let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Range
$225400.00 $418600.00
Skills Desired
Budget Management Clinical Trials Coaching Compliance CrossFunctional Teams Leadership People Management Risk Management Risk Monitoring Strategy