Head of Clinical Operations

1 week geleden


Amsterdam, Nederland Barrington James Voltijd

Position Overview:My client is seeking an experienced and visionary freelance Head of Clinical Operations in Immunotherapy to lead a phase I project for their growing pipeline of immunotherapeutic treatments. As a key member of the leadership team, you will oversee the strategy, execution, and management of all clinical trials related to our innovative immuno-oncology and immune-modulatory therapies.You will play a critical role in shaping our clinical development strategy, ensuring the successful execution of their clinical trials, and leading a multidisciplinary team of clinical operations professionals. This is an exciting opportunity to make a significant impact in a rapidly evolving therapeutic area.Key Responsibilities:Clinical Strategy Leadership:Lead the strategic planning and execution of clinical trials for immunotherapy programs, ensuring alignment with corporate objectives and regulatory requirements. Trial Design & Oversight:Oversee the design, initiation, and management of complex, multi-center, global clinical trials for immunotherapy products. Ensure rigorous scientific and operational standards are met. Team Leadership & Development:Build, mentor, and lead a high-performing clinical operations team to drive success in the execution of clinical trials, ensuring they have the skills, resources, and motivation to excel. Cross-Functional Collaboration:Work closely with the R&D, regulatory, medical affairs, and CMC teams to ensure seamless coordination across the clinical development lifecycle. Regulatory & Compliance:Ensure that all clinical operations activities adhere to GCP (Good Clinical Practice) and regulatory guidelines. Provide guidance and oversight to ensure regulatory submissions and approvals are achieved efficiently. Budget & Resource Management:Develop and manage clinical trial budgets, resources, and timelines. Identify and mitigate risks to ensure trials are completed on schedule and within budget. Clinical Site Management:Lead the selection, monitoring, and management of clinical trial sites to ensure high-quality data collection and compliance with study protocols. Data Integrity & Reporting:Oversee data integrity for clinical trials and ensure accurate and timely reporting of trial results to key stakeholders.Qualifications:Minimum of 10 years of experience in clinical operations, with at least 5 years in a leadership role within immunotherapy or oncology. Proven track record of successfully leading and managing global, multi-center clinical trials in immuno-oncology or immune-modulatory therapies. Deep understanding of regulatory requirements (FDA, EMA, ICH, etc.) and GCP compliance in clinical trial management. Strong leadership, communication, and interpersonal skills, with the ability to build and manage cross-functional teams. Expertise in clinical trial design, execution, and data analysis for biologics, including immune checkpoint inhibitors, CAR-T, and other immunotherapies. Exceptional problem-solving abilities and a strategic mindset. Ability to thrive in a fast-paced, dynamic, and evolving environment.



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