Interim VP Clinical Operations - Freelance Search conducted on behalf of one of our clients, an international biotech company. Project Details: Start : asap, 0,8 - 1 FTE Duration : 6 - 9 Months Full remote Objective Build the complete Clinical Operations function from the ground up for a biotech company with no existing clinical infrastructure. Key Responsibilities Establish the full Clinical Operations framework: governance, SOPs, processes, compliance, and documentation. Set up budgets, vendor strategy, quality systems, and inspection readiness. Build and oversee processes for Investigator‑Initiated Studies in close collaboration with Medical Affairs. Ensure regulatory compliance (FDA/EMA), define all required documentation, and partner with Legal on contracts and risk management. Provide both strategic leadership and hands‑on operational execution in an international environment. Profile Requirements VP‑level Clinical Operations leader with extensive Big Pharma experience (mandatory; US or Switzerland strongly preferred). Proven track record of building or transforming Clinical Operations organizations. Strong expertise in Oncology, IIS processes, Medical Affairs interfaces, Regulatory Affairs, and Compliance. Deep understanding of global clinical development standards, documentation requirements, and governance. Senior, confident leader capable of establishing structure and processes in a greenfield setting. SThree_Germany is acting as an Employment Business in relation to this vacancy.