🧾 Job Title: Associate Medical Director / Medical Director – Nephrology
Location: Remote – North Carolina, USA
Job ID: R-01322792
Job Type: Full-time
Category: Clinical Research
Remote Status: Fully Remote
Work Schedule: Standard (Mon–Fri)
Environment: Office
🌍 About Thermo Fisher Scientific
At Thermo Fisher Scientific, you’ll find meaningful work that has a global impact. Our mission — to make the world healthier, cleaner, and safer — drives every project we undertake.
Our Pharmacovigilance (PVG) team plays a crucial role in managing drug safety profiles, overseeing case processing, regulatory reporting, and medical monitoring throughout all phases of drug development.
This role offers full end-to-end clinical trial experience, from early development to post-marketing surveillance, providing a unique opportunity to contribute across multiple stages of product lifecycle management.
Must be legally authorized to work in the U.S. without sponsorship.
🎯 Position Overview
The Associate Medical Director / Medical Director – Nephrology provides medical oversight for clinical trials and safety programs, ensuring compliance with regulatory standards, company SOPs, and client directives.
This position involves clinical data review, medical consultation, and safety evaluation for both investigational and marketed products.
🧠 Key Responsibilities
1. General Support
Ensure PVG tasks are executed according to applicable ICH-GCP, FDA, and regulatory standards.
Provide medical consultation to project teams, clients, and investigators.
Deliver therapeutic and protocol training to assigned study teams.
Review and interpret safety and efficacy data for regulatory documents, including:
Clinical Study Reports (CSR)
IND/NDA submissions
Individual Case Safety Reports (ICSRs)
Signal detection and periodic safety reports (e.g., PBRER, PSUR, DSUR)
Risk management plans (RMP, REMS) and CTD modules
2. Clinical Trial Support
Monitor all safety variables — adverse events, lab results, medical status changes, and unblinding requests.
Engage with investigators and clients regarding protocol interpretation and clinical concerns.
Conduct medical review of serious adverse events (SAEs) and outcomes events.
Perform data review and validation, identifying potential safety concerns.
3. Marketed Product Support
Lead signal detection and aggregate report reviews for marketed drugs.
Support label updates, dossier maintenance, and risk management activities.
Medically review adverse event data from all sources (spontaneous, solicited, literature, etc.).
🎓 Qualifications
Education
|
Level |
Requirements |
|---|---|
|
Associate Medical Director |
MD (or equivalent) with clinical training and experience in Nephrology (residency/fellowship) and at least 2+ years of patient treatment experience |
|
Medical Director |
MD (or equivalent) with 2+ years clinical experience in Nephrology plus: <ul><li>1–2 years of clinical trial experience (CRO, pharma, or as Principal Investigator), OR</li><li>2 years of experience in Safety/Pharmacovigilance</li></ul> |
Active medical license preferred but not mandatory.
Equivalent combinations of education and relevant experience may be considered.
🧩 Knowledge, Skills, and Abilities
Therapeutic expertise in Nephrology and related specialties
Strong decision-making, analytical, and problem-solving abilities
Excellent oral and written communication skills
Familiarity with MedDRA and safety databases
Understanding of FDA, ICH, EMA, and GCP guidelines
Working knowledge of biostatistics, data management, and clinical operations
Ability to mentor or train junior staff
Proficiency in standard office software and data systems
Strong interpersonal and team-building skills
Flexibility to travel domestically and internationally
🧍♂️ Physical Requirements / Work Environment
Work performed in an office-based or remote setting with computer use for long periods (6–8 hours/day).
Occasional domestic and international travel (including investigator meetings or site visits).
Ability to lift up to 20 lbs (e.g., laptop, luggage).
Requires repetitive hand and wrist movements (typing, using devices).
Must maintain regular attendance and manage multiple concurrent priorities under deadlines.
💰 Compensation & Benefits
Thermo Fisher Scientific offers a competitive total rewards package, including:
Competitive remuneration and annual performance bonus
Comprehensive healthcare coverage (medical, dental, vision)
Paid Time Off and holidays
Parental leave and family support programs
Retirement savings with employer contribution (401k)
Tuition reimbursement and career development opportunities
Inclusive company culture built on Integrity, Intensity, Involvement, and Innovation
🌟 Why Join Thermo Fisher Scientific
Join an organization that empowers you to make a real-world difference by advancing global health and scientific discovery.
You’ll be part of a high-caliber clinical research and safety team shaping the future of medical innovation while growing your career in an environment that values learning, integrity, and purpose.
Be the Difference.
#StartYourStory with Thermo Fisher Scientific today.
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