Job Title: Associate Medical Director / Medical Director – Gastroenterology & Hepatology
Location: Remote, U.S./Canada
Job ID: R-01333854
Job Type: Full-Time
Category: Clinical Research
Work Schedule: Standard Office Hours (40 hours/week)
Work Environment: Office-based, Remote
Company Overview:
Join Thermo Fisher Scientific, a global leader in scientific research and clinical services, where your work directly contributes to making the world healthier, cleaner, and safer. Our Clinical Research team, powering the PPD® portfolio, delivers cutting-edge solutions to accelerate drug development, ensure patient safety, and advance global healthcare.
Position Overview:
The Associate Medical Director / Medical Director – Gastroenterology & Hepatology provides expert medical oversight for clinical trials and pharmacovigilance activities in the specialty area. This role ensures compliance with company SOPs, client directives, Good Clinical Practice (GCP), and global regulatory requirements while supporting clinical trial execution, safety monitoring, and medical guidance.
Key Responsibilities:
Clinical Trial Oversight
Provide medical review and oversight of serious adverse events (SAEs), periodic safety reports (PBRER, PSUR, DSUR), and other clinical trial deliverables.
Monitor safety variables including adverse events, lab abnormalities, and concomitant medications.
Collaborate with principal investigators and clinical teams to ensure proper interpretation of study protocols, inclusion/exclusion criteria, and clinical data.
Medical Safety & Pharmacovigilance
Lead signal detection activities and aggregate safety data review.
Contribute to labeling updates, dossier maintenance, and risk management planning.
Review adverse events from all sources, including spontaneous, solicited, and literature data.
Support pharmacovigilance training and awareness initiatives.
Cross-Functional Collaboration
Provide medical consultation to project teams, clients, and investigators.
Contribute to regulatory document preparation (e.g., CSR, IND/NDA, RMP, REMS, CTD modules).
Mentor and train junior staff on therapeutic and protocol-specific expertise.
Qualifications & Experience:
Education:
MD or equivalent degree required; active medical licensure preferred but not mandatory.
Formal Gastroenterology/Hepatology residency or fellowship.
Experience Requirements:
Clinical experience in Gastroenterology/Hepatology with patient treatment (minimum 2 years).
Industry experience in clinical trials, contract research organizations (CROs), pharmaceutical companies, or as a principal investigator (1–2 years) preferred.
Direct pharmacovigilance or medical monitoring experience (minimum 2 years) is an advantage.
Skills & Competencies:
Deep therapeutic knowledge in Gastroenterology and Hepatology.
Strong decision-making, analytical, and problem-solving abilities.
Proficient in safety databases (e.g., MedDRA), biostatistics, and clinical operations.
Excellent communication, team-building, and mentoring capabilities.
Understanding of FDA, EMA, ICH guidelines and GCP compliance.
Ability to manage multiple priorities and work independently in a fast-paced environment.
Flexibility to travel domestically and internationally as needed.
Physical Requirements:
Office-based work with occasional travel to study sites.
Prolonged periods of computer use and interaction with multidisciplinary teams.
Light to moderate lifting (up to 15–20 lbs) may be required.
Why Join Thermo Fisher Scientific:
Competitive remuneration and annual incentive bonuses.
Comprehensive healthcare and employee benefits.
Career growth in an innovative, forward-thinking global organization.
Collaborative and inclusive culture built on integrity, intensity, involvement, and innovation.
How to Apply:
Apply now to join our global team and contribute to the advancement of clinical research in Gastroenterology and Hepatology: [Apply Here]
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