Medical Director (Hematology/Oncology) - Remote U.S
Join Thermo Fisher Scientific as a Medical Director (Hematology/Oncology) - Remote U.S.
Position Details
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Work Schedule: Standard (Mon-Fri)
Environmental Conditions: Office
Join our team to make a positive impact globally, contributing to solutions in environmental protection, food safety, and cancer research.
Location/Division Specifics
Our Pharmacovigilance team manages drug safety profiles during clinical trials, overseeing case processing, regulatory reporting, and medical monitoring. You will gain comprehensive clinical trial experience across all development stages, including managing contracted services.
Key Responsibilities
- Provide medical oversight of clinical trials, ensuring compliance with SOPs, good clinical practice, and regulations.
- Attend and present at investigator and sponsor meetings, offering medical consultation to clients, investigators, and project teams.
- Review and analyze safety data, including serious adverse events, marketed product reports, and other safety-related deliverables.
- Support medical review processes, including CSR, IND/NDA reports, safety reports, and regulatory documents.
- Monitor safety variables during clinical studies and discuss medical concerns with investigators and clients.
- Manage signal detection activities, review safety reports, and support label updates and risk management activities.
- Ensure tasks are executed properly, adhering to all applicable regulations and SOPs.
- Provide therapeutic and protocol training for assigned studies.
- Assist in the preparation and review of safety and efficacy data for regulatory submissions.
Qualifications
- MD or equivalent with specialization in Oncology or Hemato-Oncology; active medical license preferred.
- Clinical experience in treating patients and industry experience in clinical trials or safety/pharmacovigilance (2+ years).
- Knowledge of safety databases, regulatory guidelines (FDA, ICH, EMA, GCP), and biostatistics.
- Strong decision-making, communication, and organizational skills.
- Ability to travel domestically and internationally.
- Fluent in English, with excellent interpersonal skills.
Physical Requirements & Work Environment
- Office environment with occasional travel and site visits.
- Ability to perform computer-based tasks and communicate effectively.
- Work may require repetitive movements and physical mobility.
Benefits
Competitive salary, annual bonus, healthcare, and career development opportunities in a culture of integrity and innovation.