Job Title: Associate Medical Director / Medical Director – Nephrology
Job ID: R-01322792
Category: Clinical Research
Job Type: Full-time
Work Location: Fully Remote (North Carolina, United States)
Work Schedule: Standard (Monday–Friday)
Environment: Office
About the Organization
At Thermo Fisher Scientific, you’ll find meaningful work that contributes to improving global health. As part of the PPD® Clinical Research division, our teams advance drug development with scientific precision and clinical excellence. Together, we enable our customers to make the world healthier, cleaner, and safer.
Department Overview: Pharmacovigilance
Our Pharmacovigilance (PVG) colleagues are detail-oriented professionals responsible for managing the safety profiles of new drugs in clinical trials. They oversee safety case processing, perform regulatory reporting, and ensure compliance through all stages of drug development. This role offers comprehensive exposure to end-to-end clinical trial processes and collaboration across global functions.
Role Summary
The Associate / Medical Director – Nephrology provides medical oversight for clinical trials, ensuring compliance with company SOPs, Good Clinical Practice (GCP), and regulatory requirements. The position involves medical monitoring, safety data review, and active participation in client interactions, investigator meetings, and regulatory deliverables.
Key Responsibilities
1. Medical Oversight & Compliance
Provide medical supervision for clinical trials to ensure adherence to SOPs, ICH-GCP, and client directives.
Serve as a medical consultant for study teams, investigators, and sponsors.
Attend and present at investigator and sponsor meetings.
Ensure delegated PVG activities are properly executed.
2. Clinical & Safety Review
Monitor safety data including adverse events (AEs), serious adverse events (SAEs), laboratory results, and medical status changes.
Perform medical review of safety reports, including individual case safety reports (ICSRs), periodic reports (PBRER, PSUR, DSUR), and other safety deliverables.
Participate in signal detection, labeling updates, and risk management activities for marketed products.
3. Documentation & Reporting
Assist in writing and reviewing key regulatory documents such as:
Clinical Study Reports (CSR)
IND/NDA submissions
Signal detection and aggregate reports
Risk Management Plans (RMP), REMS, CTD modules, etc.
Ensure all medical content is accurate, compliant, and complete.
4. Clinical Trial Support
Review inclusion/exclusion criteria and resolve medical queries from investigators.
Evaluate unblinding requests and monitor clinical safety endpoints.
Review coding listings and safety data for potential issues.
5. Client & Team Collaboration
Communicate clearly with associates, clients, and cross-functional partners.
Provide therapeutic and protocol training to project teams.
Support business development and client relationship management.
Qualifications
Education
MD or equivalent required.
Active medical licensure preferred (not mandatory).
Formal training and clinical experience in Nephrology (residency and/or fellowship) required.
Experience
For Associate Medical Director:
≥2 years of clinical experience in Nephrology.
For Medical Director:
≥2 years of Nephrology practice experience plus:
1–2 years in clinical trials (CRO, pharma, or as principal investigator), or
2+ years in Pharmacovigilance/Safety roles.
Equivalent combinations of education, training, and experience will be considered.
Note: Final level (Associate or Medical Director) will be determined based on experience, education, therapeutic expertise, and interview results.
Knowledge, Skills, and Abilities
Therapeutic expertise in Nephrology or related medical subspecialties.
Strong analytical, organizational, and decision-making abilities.
Excellent oral and written communication skills.
Knowledge of MedDRA, clinical safety databases, and regulatory systems.
Familiarity with FDA, EMA, ICH, and GCP guidelines.
Ability to interpret biostatistics, data management, and clinical operations procedures.
Proficiency in MS Office and related digital tools.
Team leadership, mentoring, and interpersonal skills.
Ability to travel domestically and internationally.
Physical & Work Environment Requirements
Office-based remote work with exposure to standard office equipment.
May require occasional site visits and travel (domestic/international).
Frequent stationary periods (6–8 hours per day).
Moderate mobility, lifting (up to 15–20 lbs.), and hand movements required.
Ability to multitask and work independently under pressure.
Requires attention to detail, sustained concentration, and adaptability to changing priorities.
Regular and consistent attendance mandatory.
Compensation & Benefits
Competitive salary with annual incentive bonus.
Comprehensive healthcare and insurance coverage.
Professional development and career growth opportunities.
Inclusive company culture based on Integrity, Intensity, Involvement, and Innovation.
Why Join Us
Become part of Thermo Fisher Scientific’s mission-driven team, contributing to life-changing science and patient safety. Help bring new therapies to market while expanding your expertise in clinical research and global pharmacovigilance.
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