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Associate Medical Director/Medical Director - Nephrology

1-2 years
Not Disclosed
10 Nov. 26, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences 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

Associate Medical Director / Medical Director – Nephrology (Remote, US)
Location: Remote, North Carolina, United States
Job ID: R-01322792
Job Type: Full Time
Category: Clinical Research
Work Model: Fully Remote

Overview
This role supports clinical research programs focused on advancing nephrology drug development. As part of a global contract research organization, the Associate Medical Director or Medical Director will provide medical oversight across clinical trials, ensuring adherence to GCP standards, regulatory requirements, and internal SOPs. The position plays a critical role in medical monitoring, safety review, trial oversight, and collaboration with cross functional teams.

Work Schedule
Standard Monday to Friday

Position Summary
The Associate/Medical Director will provide medical leadership and oversight for clinical trials across all phases of development. This includes safety evaluation, medical review, support for trial operations, and contribution to regulatory and pharmacovigilance deliverables. The role also engages in investigator interactions, sponsor meetings, and business development activities.

The position requires strong clinical expertise in nephrology along with a comprehensive understanding of drug development processes.

Key Responsibilities

General Medical Support
• Ensure adherence to ICH guidelines, client SOPs, and regulatory standards
• Provide medical consultation to study teams, investigators, and clients
• Deliver therapeutic area training and protocol training
• Review and interpret clinical data for CSRs, IND/NDA submissions, safety reports, and other regulatory documents
• Support writing and medical review of ICSRs, PBRERs, DSURs, RMPs, REMS, CTD modules, and signal detection reports

Clinical Trial Oversight
• Monitor safety data including adverse events, lab abnormalities, changes in medical status, and protocol restricted medications
• Review serious adverse events and adverse events of special interest
• Participate in discussions with investigators regarding clinical interpretations and eligibility criteria
• Validate safety data as per protocol and data validation guidelines
• Conduct medical review of outcomes events and contribute to risk assessment

Marketed Product Safety Support
• Lead or support signal detection activities
• Review aggregate safety reports and participate in label updates
• Oversee medical review of adverse events from multiple sources including spontaneous, solicited, and literature reports

Education and Experience Requirements

For Associate Medical Director:
• MD or equivalent required
• Clinical experience and formal training in Nephrology (residency and/or fellowship)
• Minimum 2 years of patient treatment experience in nephrology

For Medical Director:
• MD or equivalent required
• Clinical experience and formal training in Nephrology (residency and/or fellowship)
• Minimum 2 years of patient treatment experience
• Industry experience required:
– 1 to 2 years in clinical trials (CRO, pharmaceutical, or as a principal investigator) OR
– 2 years in pharmacovigilance or drug safety
• Experience in clinical development or medical monitoring strongly preferred

Equivalent combinations of education, training, and directly relevant experience may be considered.

Knowledge, Skills and Abilities
• Strong clinical expertise in nephrology
• Excellent decision making, analytical, and problem solving skills
• Strong written and verbal communication skills
• Experience with safety databases such as MedDRA
• Ability to work independently with attention to detail
• Understanding of FDA, ICH, EMA, and GCP guidelines
• Familiarity with biostatistics, data management, and clinical operations
• Ability to mentor and train team members
• Proficiency with standard computer applications
• Ability to travel domestically and internationally

Physical and Work Environment Requirements
• Office based remote work with regular computer use
• Occasional domestic and international travel
• Ability to remain stationary for extended periods
• Moderate physical activity including lifting up to 20 lbs when required
• Ability to manage multiple tasks in a dynamic environment
• Regular, reliable attendance required

Benefits
Thermo Fisher Scientific provides competitive compensation, annual performance incentives, comprehensive healthcare, and extensive career development opportunities. Employees benefit from a culture focused on integrity, innovation, involvement, and continuous improvement.