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Medical Director(Hematology/Oncology)

1-2 years
Not Disclosed
10 June 3, 2025
Job Description
Job Type: Remote Education: MD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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