Medical Director/Sr Medical Director - Pulmonary
Core
Provide medical oversight for clinical trials, ensuring adherence to SOPs, GCP, and regulatory requirements while consulting with clients and investigators.
Role type
Senior IC Medical Director (Pulmonary/Critical Care)
Builds
Clinical trial services and safety reporting for pharmaceutical and biotech clients
Domain
Life Sciences / Clinical Research / Pharmacovigilance
Deliverable
client delivery
Required skills
Pulmonary/Critical Care clinical expertise, clinical trial management, safety/pharmacovigilance experience, regulatory guideline knowledge (FDA/ICH/EMA/GCP), data review and analysis, mentorship
Preferred skills
Active medical licensure, clinical development/medical monitoring experience, biostatistics knowledge
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 team members; Review and analyze serious adverse events, ICSR, and periodic safety reports; Monitor safety variables and review adverse events of special interest; Assist in writing and reviewing clinical study reports (CSR), IND/NDA reports, and CTD modules.
Seniority
Senior, hands-on IC with mentorship responsibilities