Head of Immunology & Inflammation 2067836 Location: Waltham, MA (Hybrid) Therapeutic Area: Auto-Immune Job Overview: The role involves strategizing and managing the clinical development of autoimmune drug candidates, necessitating extensive experience in clinical research and a collaborative, fast-paced environment. Primary Job Responsibilities: Lead and take ownership of early stage (phase 1-2) clinical trial design Write clinical trial synopsis, protocols, and associated documents Collaborate with the clinical operations team to select investigators and provide project-related education to study site personnel and staff Plan and oversee all clinical aspects of specific programs Lead clinical study teams, monitor trials, and review and analyze safety and efficacy data Prepare clinical reports and publications, and present at scientific and medical advisory board meetings and regulatory meetings Primary Job Requirements: MD or MD/PhD with a minimum of 7-10 years of successful experience in Medical Director roles in immunology and inflammation within biotech or pharma industries Demonstrated experience in the development of autoimmune drugs to clinical Proof of Concept (PoC) and preferably to the market in the US or EU Ability to independently manage a complex clinical research program with minimal direction Demonstrated knowledge of clinical trial methodology, regulatory and compliance requirements, and expertise in the development of clinical strategy and the design of study protocols Preferred candidates will have significant clinical experience and a strong research background in autoimmune disorders, immunology, or immunotherapy #J-18808-Ljbffr Apex Systems
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