Medical Director / Sr. Medical Director – Cardiology
Company: Thermo Fisher Scientific
Job Title: Medical Director / Sr. Medical Director – Cardiology
Job ID: R-01353213
Location: Remote, North Carolina, USA
Job Category: Clinical Research / Medical Affairs / Pharmacovigilance / Clinical Safety
Employment Type: Full-time
Work Mode: Fully Remote
Work Schedule: Standard (Monday–Friday)
Job Summary
Thermo Fisher Scientific (PPD Clinical Research Services) is hiring a Medical Director / Sr. Medical Director – Cardiology to provide medical oversight for clinical trials, pharmacovigilance activities, safety review, regulatory medical support, client consultation, and business development support across the pharmaceutical product lifecycle, with a focus on cardiology studies.
Key Responsibilities
Medical Oversight & Clinical Trial Support
Provide medical oversight for clinical trials ensuring compliance with:
SOPs
Client directives
ICH-GCP
Regulatory requirements
Monitor clinical safety variables including:
Adverse Events (AE)
Serious Adverse Events (SAE)
Laboratory abnormalities
Changes in patient medical status
Concomitant medication review
Unblinding requests
Provide medical judgment for:
Inclusion / exclusion criteria interpretation
Protocol-related medical decisions
Investigator queries
Client medical concerns
Pharmacovigilance & Safety
Review and analyze:
ICSRs
SAE cases
Adverse events of special interest
Signal detection reports
Safety data listings
Periodic safety reports
Support preparation/review of:
PBRER
PSUR
DSUR
RMP
REMS
CTD modules
CSR
IND / NDA reports
Labeling reconciliation documents
Medical Consultation & Leadership
Provide medical consultation to:
Project teams
Investigators
Sponsors / clients
Deliver:
Therapeutic training
Protocol training
Medical guidance
Support business development activities and sponsor interactions.
Attend and present in:
Investigator meetings
Sponsor meetings
Client discussions
Required Qualifications
Strongly expected qualification:
MD / MBBS + advanced clinical experience
(Exact senior-level medical qualification implied by role title)
Preferred therapeutic expertise:
Cardiology
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Remote, India | Siliguri |Illinois :
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