Executive Director, Clinical Development (MD)

Role: Executive Director, Clinical Development leading immunology programs in allergy, dermatology, and related areas. Primary objectives include shaping clinical strategy, overseeing Phase 1-4 trials, ensuring patient safety, and contributing to scientific content and KOL engagement. Responsibilities encompass trial planning/execution, collaboration with cross-functional teams (clinical pharmacology, translational medicine, pharmacovigilance), regulatory document preparation (INDs, BLAs, NDAs), and external partner management (CROs, academic institutions, KOLs). Data interpretation, clinical reports, and scientific publications are key outputs. Requirements: MD with 8+ years in biotech/pharma clinical development, preferably in immunology, allergy, or dermatology, with experience in biologics or small molecules for immune and allergic diseases (e.g., chronic urticaria, allergic asthma). Expertise in clinical trial design (Phases 1-3), regulatory submissions, and patient safety oversight. Strong communication and cross-functional team collaboration skills are essential. Experience with FDA/EMA processes and regulatory filings is desirable. High-value: immunology, allergy/dermatology, biologics/small molecules, Phase 1-4 trials, regulatory submissions, KOL engagement. Work setup and travel details not specified.