Job Title
Medical Director (Hematology/Oncology)
Location
Remote – United States (North Carolina preferred)
Job ID: R-01314874
Job Type: Full-time
Work Schedule: Standard (Monday–Friday)
Work Environment: Fully Remote
Company Overview
Thermo Fisher Scientific's PPD® clinical research portfolio supports global drug development. Their Pharmacovigilance (PVG) division manages safety profiles of investigational and marketed drugs. This position provides medical oversight in hematology/oncology clinical trials, focusing on patient safety, regulatory compliance, and trial integrity.
Role Summary
The Medical Director is responsible for ensuring clinical trials are conducted in compliance with GCP, regulatory requirements, client expectations, and internal procedures. The role includes medical monitoring, safety data review, sponsor interaction, and strategic PV support for both investigational and marketed products.
Key Responsibilities
General Support
Ensure PVG execution of assigned tasks complies with SOPs and ICH guidelines
Serve as medical consultant on projects and safety concerns
Provide therapeutic/protocol training to staff and investigators
Contribute to or review CSRs, IND/NDA submissions, RMPs, REMS, CTD modules, etc.
Clinical Trial Support
Monitor clinical safety data (AEs, SAEs, labs, patient status)
Make informed decisions on eligibility, protocol deviations, and safety queries
Communicate medical concerns with investigators and sponsors
Perform medical review of AEs of special interest and serious adverse events
Review coding listings and safety data for potential safety signals
Marketed Product Support
Participate in signal detection activities
Review aggregate safety reports and contribute to label updates
Support dossier maintenance and risk management plans
Education & Experience
MD or equivalent required with specialization in Hematology or Oncology
Active medical license preferred
Clinical experience treating patients in specialty (approx. 2 years)
One of the following:
1–2 years clinical trial experience (CRO, pharma, or PI)
2 years of experience in safety/pharmacovigilance
Experience in clinical development and medical monitoring preferred
Knowledge, Skills, and Abilities
Expertise in hematology/oncology or related specialties
Proficient in safety data tools (e.g. MedDRA)
Knowledge of FDA, EMA, ICH, and GCP guidelines
Strong oral and written communication
Ability to analyze and prioritize complex data
Leadership, mentorship, and cross-functional collaboration
Familiarity with biostatistics, data management, and clinical operations
Fluent in English; willingness to travel occasionally
Physical & Work Requirements
Office-based with exposure to computer and office equipment
Long stationary periods (6–8 hours/day)
Light lifting (15–20 lbs), frequent hand and wrist motion
Occasional travel (domestic and international)
High attention to detail, intense concentration, and adaptability
Ability to work independently with minimal supervision
Compensation & Benefits
Competitive salary and annual performance bonus
Comprehensive benefits, including:
Medical, dental, and vision insurance
401(k) with company match
Paid time off and holidays
Paid parental leave
Tuition reimbursement
Employee Stock Purchase Plan (ESPP)
For more details: Thermo Fisher Total Rewards
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