Medical Director
On-siteCambridge, Massachusetts, United States or Blue Bell, Pennsylvania, United States
Job Summary
Serve as the Global Clinical Lead and Medical Monitor for one or more studies, including participation on clinical sub-teams. Contribute directly to the authoring of protocols, clinical study reports, 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 discussions of executional and 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 time, cost, and quality objectives are met. Ensure Clinical Development Standard Operating Procedures (SOPs) facilitate effective clinical research programs and comply with clinical, medical, and industry standards. Review and contribute to regulatory documents and regulatory interactions as needed.
Required Qualifications
- MD with residency training in Psychiatry
- extensive drug development experience in psychiatry
- Phase I–III clinical development in schizophrenia, bipolar disorder, ADHD, and major depressive disorder
- Five or more years of experience in the pharmaceutical industry in a Clinical Development role as a Medical Director
- Outstanding written and verbal communication skills
- 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 effectively, and meet expected timelines
- Ability to perform thorough reviews of medical and clinical trial-related documents in a timely manner
- Employment with ICON is contingent upon having the legal right to work in the country where the role is based
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.