Clinical Operations Development Lead

Role: Lead clinical development strategy and execution for immunology/autoimmune assets, overseeing all clinical activities within specific indications or across all indications for an asset. Responsibilities: co-lead Clinical Development Team (CDT), co-own the Clinical Development Plan (CDP), oversee trial budgets, timelines, and risk management, and act as primary contact for clinical activities. Leads trial strategy from First-in-Human through registration and post-approval phases, ensuring compliance with GCP and regulatory standards. Manages cross-functional collaboration, vendor selection, and oversight, with optional line management of Trial Managers and Associates. Requirements: Bachelor's in medical/paramedical sciences; 10+ years in global clinical development in biotech/pharma, experience with outsourced models, and strong leadership skills. Preferred: PhD, experience in autoimmune or rare disease trials. High-Value: Immunology/autoimmune therapeutic area, auto-immune indication expertise, phase I-III, global oversight, CRO/vendor management, regulatory document review, and GxP compliance. Work setup: Not specified.