Clinical Operations Leader In Immuno-Oncology

Overview

Job Title : Associate Director, Clinical Operations

As an Associate Director of Clinical Operations, you will spearhead the planning, execution, and oversight of clinical trials in immuno-oncology and biologics, ensuring timely delivery within budget and quality standards.

Key Responsibilities

• Develop and oversee the Clinical Development Plan for innovative portfolios, focusing on immuno-oncology.
• Lead scientific advice interactions with regulatory agencies.
• Build and maintain relationships with Key Opinion Leaders (KOLs) to validate clinical trial plans and evaluate new pipeline opportunities.
• Manage clinical trial budgets, including financial oversight of outsourced activities.
• Plan drug supply for clinical trials, coordinating with global logistics to ensure timely product availability.
• Strategically select, contract, and manage CROs and external vendors, ensuring performance meets agreed cost, quality, and timeline standards.
• 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.

Additional Responsibilities

Qualifications

Our ideal candidate possesses strong leadership skills, excellent communication abilities, and a deep understanding of clinical operations. If you are passionate about advancing healthcare through innovative research, we encourage you to apply for this exciting opportunity.

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