Global Program Clinical Head, Oncology (MD)

Role Summary

Senior Global Program Clinical Head (GPCH) serving as the clinical lead on the Global Program Team, developing and ensuring the implementation of the Clinical Development plan, leading a cross-functional team, and guiding disease area strategy in Oncology.

Responsibilities

• Responsible for clinical input to support Business Development & Licensing activities
• Serve as the Clinical Development Representative to drive transition of pre-PoC projects to Development Decision Point
• Contribute to Integrated Development Plan aligned with Target Product Profile for global regulatory approval/market access
• Drive creation and implementation of Clinical Development to support decision analysis and resource allocation
• Lead cross-functional team in creating clinical components of key documents (Protocols, Investigators’ Brochures, Clinical Study Reports, regulatory documents, licenses, registration dossiers, value and pharmacoeconomic dossiers)
• Lead interactions with external and internal stakeholders and decision boards as the medical expert
• Ensure continuous evaluation of drug safety profile with safety monitoring and post-marketing signal detection
• Support registration, market access, commercialization, and maintenance of product licenses
• Plan and implement publication and clinical communication strategy in coordination with Global Medical Affairs and Medical Writing

Qualifications

• MD with 6+ years’ experience in clinical research or drug development in industry (Phases I-III/IV, including submission dossiers)
• A passion for Oncology
• Advanced expertise in Oncology with ability to innovate in study designs and interpret program-level data
• Knowledge of Good Clinical Practice, trial design, statistics, and regulatory/clinical development processes
• Ability to establish strong scientific partnerships with key stakeholders
• Leadership and management skills with a record of delivering high-quality projects/trials in a global/matrix environment

Skills

• Clinical development strategy and publication planning
• Cross-functional leadership and stakeholder management
• Regulatory affairs and market access collaboration
• Pharmacovigilance and risk management

Education

• MD

Additional Requirements

• Location: East Hanover preferred; remote work possible with travel as defined
• Travel: Domestic and international; percentage defined by hiring manager