Medical Director / Medical Monitor – Rheumatology

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 engagementsEducation & 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 experienceRequired 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