PIn a nutshell /ppbr/ppPosition: Associate Director, Clinical Operations – Immuno-Oncology Biologics /ppbr/ppExperience: Minimum 6 years in clinical research, with at least 3 years in a leadership role managing international oncology clinical trials. /ppbr/ppWant to know more? /ppINSUD 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. /ppINSUD 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 RD 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. /ppbr/ppWhat are we looking for? /pulliLead the design, strategic planning, execution, and oversight of clinical trials in immuno-oncology and biologics, ensuring delivery within timelines, budget, and quality standards. /liliDesign and oversee the Clinical Development Plan for innovative, value-added, and biosimilar portfolios, with a focus on immuno-oncology. /liliLead scientific advice interactions with regulatory agencies. /liliBuild and maintain relationships with Key Opinion Leaders (KOLs) to validate clinical trial plans and evaluate new pipeline opportunities. /liliPrepare and manage clinical trial budgets, including financial oversight of outsourced activities. /liliPlan drug supply for clinical trials, coordinating with global logistics to ensure timely product availability. /liliSelect, contract, and manage CROs and external vendors, ensuring performance meets agreed cost, quality, and timeline standards. /liliStrategically identify countries, sites, and investigators for trial execution, optimizing scientific, regulatory, and operational feasibility. /liliOversee the establishment and coordination of independent committees (IDMC, IRC, etc.), ensuring compliance and documentation for regulatory submissions. /liliSupervise the development and review of essential clinical trial documents (protocols, informed consent forms, amendments) in collaboration with medical and scientific teams. /liliEnsure timely regulatory and ethics approvals for clinical trials and protocol amendments, managing preparation and submission of required documentation. /liliApprove and monitor study monitoring plans and related interventions. /liliReview and approve all study-related materials and operational guides. /liliOversee site documentation and ensure compliance with local and international regulatory requirements. /liliOrganize and lead investigator meetings, ensuring effective communication with investigators and partners throughout the study lifecycle. /liliSupervise site files and conduct regular quality control checks to ensure GCP compliance. /liliEnsure adherence to company SOPs, Good Clinical Practice, and all applicable regulations in all assigned clinical trials. /liliSupport Business Unit initiatives including process improvement and ad hoc projects. /li /ulpbr/ppThe challenge! /p