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Associate Medical Director/Med Dir - Neurology

1-2 years
Not Disclosed
10 Nov. 14, 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 – 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