Medical Director - Psychiatry/Neuropsychiatry - FSP

About the role

The Medical Director is a medical expert with specialized therapeutic expertise and experience across indications, clients, and drug development. They initiate and maintain medical and consultative relationships with clients, consult on early engagement and pre-award efforts, and serve as a medical monitor for contracted projects. The Medical Director may take on leadership roles by participating in initiatives, mentoring junior MDs, and managing a team of physicians. They may also represent the organization on cross-functional initiatives and lead internal projects.

Responsibilities

• Serve as the Global Clinical Lead and medical monitor for one or more studies, including participation in clinical subteams.
• Contribute to direct authorship 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 for data presentation, trial updates, and discussions of executional or strategic development issues.
• Contribute to strategic discussions related to clinical development plans and indication prioritization.
• Collaborate with clinical operations to oversee and coordinate operational aspects of ongoing projects, ensuring goals of time, cost, and quality are met.
• Ensure standard operating procedures (SOPs) for Clinical Development facilitate effective clinical research programs and comply with clinical/medical and industry standards.
• Critically review and contribute to regulatory documents and interactions as needed.
• Work cross-functionally to ensure trial issues and execution are well-coordinated with partners from multiple departments.
• Participate in protocol deviation teams, cross-functional safety review teams, and study teams.

Qualifications

• MD and residency training in psychiatry with extensive drug development experience, particularly in clinical development (Phase 1-3) for indications such as schizophrenia, bipolar disorder, ADHD, and major depressive disorder.
• Five or more years of experience in the pharmaceutical industry in a clinical development role (e.g., Medical Director or Senior Medical Director).
• Outstanding written and verbal communication skills, 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.