Associate Director, Clinical Operations - Immuno-Oncology & Biologics

Overview

Position : Associate Director, Clinical Operations – Immuno-Oncology & Biologics

Experience : Minimum 6 years in clinical research, with at least 3 years in a leadership role managing international oncology clinical trials.

Company

INSUD PHARMA operates across the entire pharmaceutical value chain, providing specialized knowledge and expertise in scientific research, development, manufacturing, sales, and marketing of a wide range of active pharmaceutical ingredients (APIs), finished dosage forms (FDFs), and branded pharmaceutical products, adding value to human and animal health.

INSUD PHARMA’s activities are organized into three synergistic business areas : Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience), with over 9,000 professionals in more than 50 countries, 20 state-of-the-art facilities, 15 specialized R&D centers, 12 commercial offices, and more than 35 pharmaceutical subsidiaries serving 1,150 clients in 96 countries worldwide. INSUD PHARMA believes in innovation and sustainable development.

Responsibilities

• Lead the design, strategic planning, execution, and oversight of clinical trials in immuno-oncology and biologics, ensuring delivery within timelines, budget, and quality standards.
• Design and oversee the Clinical Development Plan for innovative, value-added, and biosimilar portfolios, with a focus 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.
• Prepare and 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.
• Select, contract, and manage CROs and external vendors, ensuring 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.
• Review and approve all study-related materials and operational guides.
• Oversee site documentation and ensure compliance with local and international regulatory requirements.
• Organize and lead investigator meetings, ensuring effective communication with investigators and partners throughout the study lifecycle.
• Supervise site files and conduct regular quality control checks to ensure GCP compliance.
• Ensure adherence to company SOPs, Good Clinical Practice, and all applicable regulations in all assigned clinical trials.
• Support Business Unit initiatives including process improvement and ad hoc projects.

#J-18808-Ljbffr