Global Program Clinical Head, Neuroscience (M.D.)

Band

Level 7

 

Job Description Summary

Onsite
#LI-Onsite
East Hanover, New Jersey

About the role:
With over 60 years history in neuroscience, Novartis brought landmark therapies to patients with Multiple Sclerosis, Alzheimer’s disease, Parkinson’s Disease, Epilepsy, Depression and Migraine. We have a world-class pipeline in neuro-inflammation, 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 cross-functional 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 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, Investigator’s 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
   

Video Link  https://www.youtube.com/watch?v=ggbnzRY9z8w 

This 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 I-III/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 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

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: $