Sr. Medical Director, Clinical Development (Psychiatry)

Role: Senior Medical Director responsible for clinical development in neuropsychiatric indications, overseeing protocol design, data review, and medical monitoring of Phase 2 and 3 trials. Key objectives include leading clinical programs, contributing to regulatory submissions, and representing the company externally. Responsibilities involve global trial leadership, medical review, strategic input on therapeutic priorities, and cross-functional collaboration across departments such as regulatory, preclinical, CMC, and commercial. The role includes stakeholder engagement with regulators, investigators, and thought leaders, as well as overseeing operational aspects and ensuring compliance with SOPs. Requirements: MD with psychiatry expertise, 5-7+ years in pharma, experience in drug development stages, and successful interactions with regulatory agencies, including NDA/BLA processes. Preferred skills include strong communication, leadership, and ability to manage complex projects in a matrix environment, with approximately 25% domestic and international travel. The position operates in a hybrid model based in Waltham, MA, with 60% onsite presence. High-value specifics include focus on psychiatric/neuropsychiatric disorders, clinical trial leadership, regulatory engagement, and cross-departmental coordination within a biopharma setting.