Director of Immuno-Oncology Clinical Trials

Overview

The ideal candidate will lead the development and execution of clinical trials in immuno-oncology, ensuring timely delivery within budget and quality standards.

Responsibilities

• Design and oversee the clinical development plan for innovative and biosimilar portfolios, with a focus on immuno-oncology.
• Lead scientific advice interactions with regulatory agencies to ensure compliance and validation of clinical trial plans.
• Build and maintain relationships with Key Opinion Leaders (KOLs) to evaluate new pipeline opportunities and validate clinical trial plans.
• Manage clinical trial budgets, including financial oversight of outsourced activities, to ensure optimal resource allocation.
• Plan drug supply for clinical trials, coordinating with global logistics to ensure timely product availability.
• Select, contract, and manage CROs and external vendors to ensure performance meets agreed cost, quality, and timeline standards.
• Strategically identify countries, sites, and investigators for trial execution, optimizing scientific, regulatory, and operational feasibility.
• Oversee the establishment and coordination of independent committees (IDMC, IRC, etc.), ensuring compliance and documentation for regulatory submissions.
• Supervise the development and review of essential clinical trial documents (protocols, informed consent forms, amendments) in collaboration with medical and scientific teams.
• Ensure timely regulatory and ethics approvals for clinical trials and protocol amendments, managing preparation and submission of required documentation.
• Approve and monitor study monitoring plans and related interventions to ensure adherence to Good Clinical Practice (GCP).
• Review and approve all study-related materials and operational guides to ensure accuracy and consistency.
• Oversee site documentation and ensure compliance with local and international regulatory requirements.
• Organize and lead investigator meetings to facilitate effective communication and collaboration with investigators and partners.
• Supervise site files and conduct regular quality control checks to ensure GCP compliance and data integrity.
• Ensure adherence to SOPs, GCP, and all applicable regulations in all assigned clinical trials.
• Support Business Unit initiatives and ad hoc projects as needed.

Requirements

Selection Process

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