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Medical Director – Psychiatry
Thermo Fisher Scientific. Provide medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed .
About the role
Key responsibilities & impact- Provide medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed
- Attend and present at investigator and sponsor meetings
- Provide medical consultation to clients, investigators, project team members, and associates
- Support business development activities
- Provide medical review and analysis of clinical trial serious adverse events
- Ensure tasks delegated to medical monitors are properly executed
- Adhere to applicable regulations, ICH guidelines, client directives, corporate policies, SOPs, and study-specific WPDs
- Provide therapeutic and protocol training on assigned studies
- Monitor safety variables including adverse events, laboratory abnormalities, changes in patient medical status, concomitant medication restrictions, and un-blinding requests
- Discuss medical concerns with principal investigators and clients and interpret inclusion/exclusion criteria
- Review adverse events of special interest, serious adverse events, and clinical outcomes events
- Perform data review and validation, including coding listings and/or full safety data, to identify potential safety concerns
- Mentor and train other staff
Requirements
What you’ll need- MD or equivalent required
- Active medical licensure preferred but not required
- Clinical experience in Psychiatry and formal training in Psychiatry (residency and/or fellowship)
- Patient treatment experience comparable to 2 years
- For Senior Medical Director: suitable clinical trial experience in a contract research organization or pharmaceutical company comparable to 1–2 years
- Preference toward clinical development/medical monitoring experience
- Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
- Therapeutic expertise in Psychiatry
- Working knowledge of relevant safety databases, e.g. MedDRA
- Flexibility to travel domestically and internationally
- Proficiency in basic computer applications
- Fluent in spoken and written English
- Understanding of FDA, ICH, EMA and GCP guidelines
- Working knowledge of biostatistics, data management, and clinical operations procedures
- Ability to pass a comprehensive background check, including drug screening where applicable
- Must be legally authorized to work in the hiring country without sponsorship
- Regular and consistent attendance
Benefits
Comp & perks- Competitive remuneration
- Annual incentive plan bonus
- Healthcare
- Range of employee benefits
- Career and development prospects
- Innovative, forward-thinking organization
- Company culture emphasizing integrity, intensity, involvement, and innovation