Associate Medical Director / Medical Director – Neurology
Job ID: R-01323565
Category: Clinical Research
Type: Full-time
Work Model: Fully Remote
Schedule: Monday–Friday (Standard)
Environment: Office
Company Overview
Join Thermo Fisher Scientific’s global CRO division (PPD® Clinical Research). The team works to bring cures to market by managing clinical trials, drug development processes, and pharmacovigilance activities across all phases.
Role Purpose
The Associate/Medical Director provides medical oversight for clinical trials, ensuring compliance with GCP, regulatory standards, company SOPs, and client directives. The role involves medical monitoring, PV support, clinical trial review, and client consultation.
Key Responsibilities
1. General Support
Ensure tasks delegated to PVG are executed correctly.
Adhere to applicable regulations (ICH, FDA, EMA, GCP), client SOPs, and PPD SOPs.
Provide medical consultation to project teams, investigators, and clients.
Deliver therapeutic area training and protocol training.
Review and interpret medical content in:
CSR
IND/NDA sections
ICSRs
PBRER/PSUR/DSUR
RMP, REMS
CTD modules
2. Clinical Trial Medical Oversight
Monitor safety variables including:
AEs
SAEs
Lab abnormalities
Concomitant medication reviews
Handle unblinding requests when needed.
Discuss medical concerns with investigators/clients throughout the study.
Provide medical review of SAEs, AESIs, and outcome events.
Perform data reviews and coding assessments for safety signals.
3. Marketed Products Support
Lead signal detection activities.
Medically review AE/SAE data from all sources.
Contribute to label updates and regulatory dossier maintenance.
Support risk management plans and REMS activities.
Required Qualifications
Education
MD or equivalent (mandatory)
Neurology training (residency/fellowship)
Active medical license preferred
Experience Requirements
For Associate Medical Director:
Neurology clinical experience (≈2 years)
For Medical Director level, one of the following:
1–2 years clinical trial experience (CRO/Pharma/PI role)
OR 2 years direct pharmacovigilance experience
Industry equivalency may be considered.
Skills & Abilities
Expertise in Neurology
Strong decision-making, analytical ability, and problem solving
Excellent verbal & written communication
Working knowledge of MedDRA and safety databases
Understanding of FDA, ICH, EMA, and GCP
Knowledge of biostatistics, data management, clinical operations
Ability to train and mentor teams
Ability to travel domestically/internationally
Physical & Work Requirements
Stationary work: 6–8 hours/day
Frequent computer use
Light travel; occasional lifting (15–20 lbs)
Independent working style with high concentration and multitasking
High interaction with diverse teams
Benefits
Competitive compensation
Annual performance bonus
Healthcare coverage
Professional development opportunities
Strong company culture emphasizing:
Integrity
Intensity
Involvement
Innovation
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