Medical Director - FSP

Remote- US locations- East Coast preferred. Psychiatric/Neuropsychiatric experience required.

Responsibilities

• Serve as the Global Clinical Lead and medical monitor for 1 or more studies, including participation on the clinical subteams of those programs
• Direct authorship contributions in protocols, clinical study reports, study documents, regulatory documents, and external publications
• Provide medical review of clinical trial data and medical monitoring of clinical trials
• Interact with senior management in the context of data presentation, trial updates, and discussions of executional or strategic development issues
• Contribute to strategic discussions related to clinical development plans and indication prioritization
• In collaboration with clinical operations, oversee and coordinate the operational aspects of ongoing projects to ensure that goals of time, cost, and quality performance expectation are met
• Ensure that standard operating procedures (SOP) for Clinical Development facilitate the development of effective clinical research programs and are compliant with clinical/medical and industry standards
• Critically review and contribute to regulatory documents and interactions as needed
• Key trial-related responsibilities include medical monitoring, review of eligibility forms, ongoing clinical data review, participation on protocol deviation teams, participation on cross-functional safety review teams, and participation on study teams and clinical subteams
• Work cross-functionally to ensure project trial issues and execution are well coordinated with partners from multiple departments

Qualifications

• MD and residency training in psychiatry with extensive drug development experience in psychiatry, particularly clinical development (phase 1-3) experience in indications of schizophrenia, bipolar disorder, ADHD, major depressive disorder
• 5 or more years of experience in the pharmaceutical industry in a clinical development role (medical director or senior medical director)
• Outstanding written and verbal communication, with experience interacting with and presenting to senior management and external audiences
• Ability to manage complexity and ambiguity in a highly matrixed work environment
• Strong leadership and collaborative interpersonal skills
• Ability to work independently, prioritize tasks efficiently, and meet expected time frames
• Ability to perform thorough reviews of various medical and trial-related documents in a timely manner