Associate Medical Director / Medical Director – Nephrology (Fully Remote, USA)
Location: Remote, North Carolina, United States
Job ID: R-01322792
Job Type: Full-Time
Category: Clinical Research
Work Model: Fully Remote
Overview
Thermo Fisher Scientific’s PPD® clinical research services team is advancing global healthcare by accelerating the development of innovative therapies. As part of a leading international CRO, our teams combine scientific excellence with operational expertise to support the safe and efficient conduct of clinical trials worldwide.
We are seeking an Associate Medical Director or Medical Director – Nephrology to provide medical oversight, clinical guidance, and scientific leadership across global clinical programs. This role is fully remote and ideal for experienced physicians specializing in Nephrology and interested in contributing to high-impact drug development.
Role Summary
The Associate/Medical Director ensures high-quality medical oversight of clinical trials, maintains compliance with global regulations, and delivers strategic medical insight across safety, pharmacovigilance, and clinical development programs. The role includes medical monitoring, safety data review, regulatory support, and collaboration with sponsors, investigators, and internal teams.
Key Responsibilities
Medical & Safety Oversight
Provide end-to-end medical oversight for clinical trials in compliance with SOPs, client requirements, GCP, and regulatory guidelines.
Review and assess serious adverse events, adverse events of special interest, and safety outcomes.
Support analysis and authoring of medical and safety documents, including CSR, IND/NDA sections, ICSR, aggregate reports, REMS, RMP, PBRER, PSUR, and DSUR.
Clinical Trial Support
Oversee safety variables such as adverse events, laboratory abnormalities, concomitant medications, and unblinding requests.
Address investigator questions, protocol-related medical issues, and eligibility criteria interpretations.
Conduct therapeutic and protocol training for internal teams and study sites.
Pharmacovigilance and Marketed Product Activities
Lead signal detection activities and review aggregate safety reports.
Contribute to label updates, risk management plans, and dossier maintenance.
Perform medical review of AE and SAE data from multiple sources including literature, solicited, and spontaneous reports.
Cross-Functional Leadership
Provide consultation to project teams and clients, ensuring open communication and clear guidance.
Ensure that delegated PVG tasks are completed according to standards.
Support business development initiatives through scientific expertise and presentations.
Experience Required
For Associate Medical Director
MD or equivalent with formal training in Nephrology (residency/fellowship).
Minimum 2+ years of clinical practice experience treating nephrology patients.
Industry or clinical trial exposure preferred but not mandatory.
For Medical Director
MD or equivalent with specialized training in Nephrology and 2+ years of patient-care experience.
1–2 years of clinical trial experience in a CRO/pharmaceutical environment or
2+ years of experience in Safety/Pharmacovigilance.
Preferably experienced in clinical development or medical monitoring.
Equivalent combinations of relevant training, education, and experience may be considered.
Required Skills & Competencies
Strong therapeutic expertise in Nephrology; broader medical specialty knowledge is beneficial.
Proficiency in decision-making, problem-solving, analytical review, and medical judgment.
Excellent written and verbal communication skills; fluent English required.
Understanding of FDA, EMA, ICH, and GCP guidelines.
Familiarity with safety databases such as MedDRA.
Ability to analyze complex information and manage sensitive data.
Competence in biostatistics, data management, and clinical operations frameworks.
Strong interpersonal skills with the ability to mentor and guide teams.
Ability to work independently and collaborate across global functions.
Work Environment & Physical Requirements
Office-based remote environment with extensive computer use.
Frequent seated work (6–8 hours/day) with repetitive hand movements.
Occasional domestic and international travel may be required.
Ability to lift and carry light equipment such as laptops (15–20 lbs).
Ability to interact with diverse stakeholders and handle multiple priorities under pressure.
Why Join Thermo Fisher Scientific?
Thermo Fisher Scientific offers a dynamic, innovation-driven culture with strong career development pathways. Employees benefit from competitive compensation, annual bonuses, and comprehensive healthcare programs. Our mission-driven organization is committed to improving global health, advancing science, and creating meaningful impact.
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