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.
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.
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. 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.
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.
Oversee site documentation and ensure compliance with local and international regulatory requirements.
Supervise site files and conduct regular quality control checks to ensure GCP compliance.
Support Business Unit initiatives including process improvement and ad hoc projects.
Manage resources, budgets, and vendors to ensure successful trial execution.
Advanced degree in Health Sciences (MD, PharmD, PhD preferred).
Fluent in Spanish and English.
Minimum 6 years of experience in clinical research, with at least 3 years in leadership of international oncology trials.
Proven experience in budget management, team leadership, and vendor oversight.
Two interviews (virtual and onsite).
We value diversity and foster inclusion in all our selection and professional development practices.