Medical Director – FSP

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Serve as the Global Clinical Lead and medical monitor for one or more studies, including participation on clinical subteams • Contribute directly as an author to 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 regarding data presentations, trial updates, and executional or strategic development issues • Contribute to strategic discussions on clinical development plans and indication prioritization • Collaborate with clinical operations to oversee and coordinate operational aspects of ongoing projects, ensuring time, cost, and quality goals are met • Ensure Clinical Development SOPs 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 coordinate trial issues and execution with partners across multiple departments

🎯 Requirements

• MD required • Residency training in psychiatry required • Extensive drug development experience in psychiatry, particularly Phase 1–3 clinical development • Experience in schizophrenia, bipolar disorder, ADHD, and major depressive disorder indications • 5 or more years of pharmaceutical industry experience in a clinical development role as a Medical Director or Senior Medical Director • Outstanding written and verbal communication skills, including experience 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 and timely reviews of medical and trial-related documents