Medical Director / Medical Monitor – Rheumatology
Talent Groups, New York, NY, United States
Role Overview
The Medical Director/Medical Monitor provides end-to-end medical oversight across the pharmaceutical product lifecycle, ensuring compliance with regulatory standards such as FDA, ICH, EMA, and Good Clinical Practice.
This role supports clinical trials, pharmacovigilance (PV), and marketed product safety activities while acting as a key medical advisor to internal teams, investigators, and clients.
Key Responsibilities
1. Medical Oversight & Leadership
Provide medical oversight for all assigned projects across clinical development and post-marketing phases
Ensure adherence to SOPs, regulatory guidelines, and client requirements
Serve as the primary medical expert for rheumatology programs
2. Clinical Trial Support
Monitor and evaluate safety data including adverse events (AEs), serious adverse events (SAEs), and lab abnormalities
Provide medical review and causality assessment of safety events
Support protocol development and interpretation (e.g., inclusion/exclusion criteria)
Participate in investigator meetings and client discussions
Review unblinding requests and clinical outcomes
Ensure patient safety and data integrity throughout trials
3. Pharmacovigilance & Drug Safety
Review Individual Case Safety Reports (ICSRs) and aggregate safety reports
Author/review safety documents such as:
PSUR/PBRER
DSUR
Risk Management Plans (RMP)
REMS documents
Conduct signal detection and risk-benefit analysis
Evaluate safety data from multiple sources (clinical trials, literature, spontaneous reports)
4. Medical Writing & Regulatory Support
Contribute to and review:
Clinical Study Reports (CSR)
CTD Modules
IND/NDA submissions
Labeling and safety updates
Ensure scientific accuracy and completeness of all deliverables
5. Stakeholder Collaboration
Provide medical consultation to investigators, sponsors, and internal teams
Train teams on therapeutic area and study protocols
Communicate complex medical data clearly to stakeholders
Support business development activities and client engagements
Education & Experience
MD with board certification in Rheumatology
At least one of the following:
2+ years clinical practice in rheumatology
1–2 years clinical research experience (CRO/pharma/PI role)
2+ years pharmacovigilance/drug safety experience
Required Skills & Competencies
Strong expertise in rheumatology
Knowledge of global regulatory frameworks (FDA, ICH, EMA, GCP)
Experience with safety databases like MedDRA
Solid understanding of biostatistics and clinical data interpretation
Excellent communication and stakeholder management skills
Strong analytical thinking and decision-making ability
Ability to work independently and manage complex data
The Medical Director/Medical Monitor provides end-to-end medical oversight across the pharmaceutical product lifecycle, ensuring compliance with regulatory standards such as FDA, ICH, EMA, and Good Clinical Practice.
This role supports clinical trials, pharmacovigilance (PV), and marketed product safety activities while acting as a key medical advisor to internal teams, investigators, and clients.
Key Responsibilities
1. Medical Oversight & Leadership
Provide medical oversight for all assigned projects across clinical development and post-marketing phases
Ensure adherence to SOPs, regulatory guidelines, and client requirements
Serve as the primary medical expert for rheumatology programs
2. Clinical Trial Support
Monitor and evaluate safety data including adverse events (AEs), serious adverse events (SAEs), and lab abnormalities
Provide medical review and causality assessment of safety events
Support protocol development and interpretation (e.g., inclusion/exclusion criteria)
Participate in investigator meetings and client discussions
Review unblinding requests and clinical outcomes
Ensure patient safety and data integrity throughout trials
3. Pharmacovigilance & Drug Safety
Review Individual Case Safety Reports (ICSRs) and aggregate safety reports
Author/review safety documents such as:
PSUR/PBRER
DSUR
Risk Management Plans (RMP)
REMS documents
Conduct signal detection and risk-benefit analysis
Evaluate safety data from multiple sources (clinical trials, literature, spontaneous reports)
4. Medical Writing & Regulatory Support
Contribute to and review:
Clinical Study Reports (CSR)
CTD Modules
IND/NDA submissions
Labeling and safety updates
Ensure scientific accuracy and completeness of all deliverables
5. Stakeholder Collaboration
Provide medical consultation to investigators, sponsors, and internal teams
Train teams on therapeutic area and study protocols
Communicate complex medical data clearly to stakeholders
Support business development activities and client engagements
Education & Experience
MD with board certification in Rheumatology
At least one of the following:
2+ years clinical practice in rheumatology
1–2 years clinical research experience (CRO/pharma/PI role)
2+ years pharmacovigilance/drug safety experience
Required Skills & Competencies
Strong expertise in rheumatology
Knowledge of global regulatory frameworks (FDA, ICH, EMA, GCP)
Experience with safety databases like MedDRA
Solid understanding of biostatistics and clinical data interpretation
Excellent communication and stakeholder management skills
Strong analytical thinking and decision-making ability
Ability to work independently and manage complex data