Head of Clinical Operations

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.