Medical Director - FSP

Responsibilities

• Serve as the Global Clinical Lead and medical monitor for one or more studies, including participation on the clinical subteams of those programs.
• Make 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 goals of time, cost, and quality performance expectations 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.
• 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, and major depressive disorder.
• Five 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.