US-NJ, Global Program Clinical Head- Neuroscience-Alzheimer s 232957BR-MZ
Global Program Clinical Head- Neuroscience-Alzheimer s
Global Drug Development
East Hanover, NJ
Research & Development
The Global Program Clinical Head (GPCH) is the global clinical leader responsible for one or more clinical programs across indications, involving one or multiple compounds. The GPCH owns the risk benefit assessment for the program(s), and as the leader of Global Clinical Team(s) (GCT) is accountable for the design, implementation, and execution of a clinical development program(s) to support decision milestones, regulatory requirements and market access. The GCPH may contribute to disease area strategy.
1) Leads the GCT, represents Clinical Development on the Global Program Team (GPT) 2) 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) 3) May support Business Development & Licensing (BD&L) activities 4) Post-DDP, 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 5) 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) 6) Together with 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) 7) 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 8) Supports TAH with leading the peer-review of IDPs, CTPs, and other clinical documents across various indications and programs; and with driving excellence across clinical trial strategy, design, and execution 9) May contribute to development of TA strategies 10) Plans and executes publication and clinical communication strategy in coordination with GMA and Medical Writing, and provides input into key external presentations 11) Drives scenario development for Clinical Development to support decision analysis and optimal resource allocation in program(s)
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MD or equivalent (preferred), PhD, or PharmD degree required.
Specialization in a subspecialty may be needed.
Advanced clinical training/knowledge in medical/scientific area aligned with TA required
6 years (MD or equivalent) 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 required, 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
Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development process
Experience with submissions and health authorities required
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
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