Medical Director/Senior Medical Director - Endocrinology
New
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Thermo Fisher ScientificPharmaceuticals
United StatesFull-TimeSenior
Salary$200,000.00–$278,900.00 per year
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Job Details
- Languages
- English
- Experience
- 2 years of patient treatment experience
- Required Skills
- GCP
Requirements
- MD or equivalent degree required.
- Formal training in Endocrinology, Diabetes & Metabolism (residency/fellowship).
- Minimum of 2 years of patient treatment experience.
- For Senior level: Additional 1-2 years of clinical trial experience in a CRO, pharmaceutical company, or as a principal investigator, OR 2 years of experience in safety/Pharmacovigilance.
- Working knowledge of safety databases (e.g., MedDRA).
- Understanding of FDA, ICH, EMA, and GCP guidelines.
- Working knowledge of biostatistics, data management, and clinical operations.
- Excellent oral and written communication skills in English.
- Strong decision-making, problem-solving, and analytical skills.
- Flexibility for domestic and international travel.
- Ability to act as a mentor and trainer to staff.
Responsibilities
- Provide medical oversight of clinical trials to ensure adherence to SOPs, client directives, GCP, and regulatory requirements.
- Monitor safety variables including AEs, laboratory abnormalities, and patient medical status throughout clinical studies.
- Provide medical consultation to study teams, investigators, and clients to support decision-making.
- Review and analyze serious adverse events, clinical outcome events, and adverse events of special interest.
- Contribute to the writing and review of clinical trial documentation including CSRs, IND/NDA reports, and safety reports.
- Manage signal detection activities and support dossier maintenance for marketed products.
- Present at investigator and sponsor meetings and support business development activities.
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