Job Title: Associate Medical Director / Medical Director – Neurology
Location: Remote, U.S./Canada
Job ID: R-01323565
Job Type: Full-Time
Category: Clinical Research
Work Schedule: Standard (Mon-Fri)
Work Environment: Office-based, Remote
Company Overview:
Thermo Fisher Scientific is a global leader in scientific research and clinical services. Our Clinical Research team, powering the PPD® portfolio, enables pharmaceutical and biotech clients to bring life-changing therapies to patients worldwide. With a commitment to innovation, quality, and patient safety, we provide end-to-end clinical research services across all phases of drug development.
Position Overview:
The Associate Medical Director / Medical Director – Neurology provides medical oversight for clinical trials, pharmacovigilance, and patient safety activities in the neurology therapeutic area. This role ensures compliance with company SOPs, client directives, Good Clinical Practice (GCP), and global regulatory requirements. The position involves reviewing safety data, providing medical guidance, supporting regulatory submissions, and mentoring clinical teams.
Key Responsibilities:
Clinical Trial Oversight
Provide medical review and oversight of serious adverse events (SAEs), individual case safety reports (ICSRs), periodic safety reports (PBRER, PSUR, DSUR), and other regulatory documents.
Monitor safety variables, including adverse events, lab abnormalities, and protocol deviations.
Collaborate with principal investigators, study sites, and clinical teams to address medical concerns and ensure protocol compliance.
Medical Safety & Pharmacovigilance
Lead signal detection activities, aggregate safety data review, and risk management planning.
Contribute to labeling updates, dossier maintenance, and regulatory reporting.
Review adverse events from all sources, including spontaneous reports, literature, and solicited data.
Cross-Functional Collaboration
Provide medical consultation to project teams, clients, and investigators.
Support preparation and review of regulatory documents, including CSR, IND/NDA reports, REMS, RMP, and CTD modules.
Mentor and train junior staff on neurology therapeutic expertise and clinical processes.
Education & Experience:
MD or equivalent required; active medical licensure preferred but not mandatory.
Clinical experience in Neurology with patient treatment (minimum 2 years).
Industry experience in clinical trials, CROs, pharmaceutical companies, or as a principal investigator (1–2 years) preferred.
Direct experience in pharmacovigilance or medical monitoring (minimum 2 years) is advantageous.
Job leveling (Associate Medical Director vs. Medical Director) will be determined based on education, experience, therapeutic expertise, and interview outcomes.
Skills & Competencies:
Strong therapeutic knowledge in Neurology and related subspecialties.
Excellent decision-making, problem-solving, organizational, and analytical skills.
Proficient in safety databases (e.g., MedDRA), biostatistics, and clinical operations procedures.
Effective communication, team-building, and mentoring capabilities.
Understanding of FDA, EMA, ICH, and GCP guidelines.
Ability to work independently, prioritize sensitive information, and manage multiple tasks in a fast-paced environment.
Flexibility to travel domestically and internationally as needed.
Physical Requirements / Work Environment:
Office-based work with occasional travel to study sites.
Prolonged computer use and interaction with multidisciplinary teams.
Light to moderate lifting (up to 15–20 lbs) may be required.
Ability to perform under stress and manage multiple responsibilities simultaneously.
Why Join Thermo Fisher Scientific:
Competitive remuneration and annual incentive bonus.
Comprehensive healthcare and employee benefits.
Career growth in a globally recognized, innovative organization.
Collaborative, inclusive culture built on integrity, intensity, involvement, and innovation.
How to Apply:
Apply now to join a global team advancing clinical research in Neurology and contribute to life-changing therapies worldwide: [Apply Here]
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