Medical Director/Sr Medical Director - Pulmonary
Core
Provide medical oversight of clinical trials, safety reporting, and regulatory compliance for pharmaceutical and biotech clients.
Role type
Senior IC Medical Director (Pulmonary/Critical Care)
Builds
Clinical trial deliverables, safety reports (CSR, ICSR, PSUR), and regulatory documentation for top 50 pharma companies and 750+ biotechs.
Domain
Clinical Research / Pharmacovigilance / Pulmonary Medicine
Deliverable
client delivery
Required skills
Pulmonary/Critical Care clinical expertise, medical trial oversight, safety data analysis, regulatory guideline knowledge (FDA/ICH/EMA/GCP), therapeutic training, mentorship
Preferred skills
Industry clinical trial experience (CRO/Pharma/PI), Safety/Pharmacovigilance experience, active medical licensure
Technologies
Medra, safety databases, clinical trial software
Responsibilities
Manage medical aspects of contracted tasks across the pharmaceutical product life-cycle; Provide medical consultation to clients, investigators, and project teams; Review and analyze serious adverse events and periodic safety reports; Monitor safety variables and validate clinical data; Assist in writing and reviewing clinical study reports and regulatory modules.
Seniority
Senior, hands-on IC with mentorship
