Pioneering Medicines: Associate Director / Director, Clinical Operations

Role: Associate Director or Director, Clinical Development Operations, responsible for leading early-phase (Phase 1/2) clinical trials within Pioneering Medicines' expanding portfolio. Responsibilities include end-to-end program ownership, trial design, regulatory milestones, vendor and site management, and cross-functional collaboration with scientists, safety, biostatistics, and regulatory teams. The role demands hands-on oversight of trial execution, data integrity, and budget management, ensuring compliance with GxP and global regulatory standards. Qualifications: minimum 10+ years in drug development, with at least 5 years managing clinical trials, preferably in early-phase or innovative modalities such as biologics, cell, or gene therapies. A bachelor's degree in life sciences is required; advanced degrees or relevant certifications are a plus. Experience with metabolic, obesity, oncology, or rare diseases is highly desirable. Technical proficiency with clinical systems (EDC, CTMS, eTMF), and vendor management expertise are essential. The role involves domestic and international travel (~10%) and requires a proactive, autonomous approach in a lean, high-ownership environment. High-value specifics: early-phase trials, novel therapeutic modalities, cross-functional collaboration, global vendor oversight, and regulatory deliverables.