Global Program Clinical Head, Gene Therapies and Rare Disease (MD, PhD)

Job Description Summary

Novartis is seeking a Global Program Clinical Head (GPCH) for Gene Therapies and Rare Disease early development projects. The GPCH works to ensure early development plans and proof of concept studies are aligned with the Development strategy and leads licensing evaluations for Clinical Development for Gene therapies across various indications. As an integrative leader, the GPCH is accountable to lead decision milestones, regulatory requirements and market access for those early compounds in collaboration with relevant other functions.

 

Job Description

About the role:
Your Key Responsibilities:

• Serves as the Clinical Development Representative on Biomedical Research (BR) clinical/project teams to drive transition of pre-PoC (Proof of Concept) projects to Development Decision Point (DDP) 
• Supports Business Development & Licensing (BD&L) activities 
• Leads the GCT, represents Clinical Development on the Global Program Team (GPT)
• Post-Transition Development Point, leads the development and execution of the clinical strategy. Develops an endorsed 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 multiple treatment indications and/or multiple programs 
• Leads 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, pharmacoeconomic dossiers) with high quality and consistency with IDP and 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) 
• Together with Preclinical Safety, Translational Medicine and Patient Safety, ensures continuous evaluation of drug safety profile, including safety monitoring of clinical studies and signal detection from post-marketing surveillance. Serves as a core member of the Safety Management Team (SMT) 
• As the medical expert, leads 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 (GMA), Marketing, Health Economics & Outcomes Research), and internal decision boards.
   

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 employee’s expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 10% travel.
 

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

Role Requirements:
Essential Requirements:

• MD or PhD with advanced clinical training/knowledge in medical/scientific area aligned with TA required and 6+ years’ experience in clinical research or drug development in an industry environment spanning clinical activities in Phases I-III/IV, including submission dossiers.
• Advanced knowledge of assigned therapeutic area, 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.
• 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.
• Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development process.
• Experience with submissions and health authorities.
• Demonstrated ability to establish strong scientific partnership with key stakeholders.
   

Essential Preferred:

• Medical Board certification preferred for MD or equivalent; Clinical practice experience ≥ 10 years (including residency) preferred for MD or equivalent PhD with 10 years
• Neurology, Neuromuscular or Neurodevelopmental Disorders, Genetics, Pediatrics or Neuroscience background is strongly preferred
   

Novartis Compensation and Benefit Summary:

The pay rang