Responsibilities Advise sponsors on product development strategy, protocol design, endpoint selection, and clinical trial feasibility for Phase I–IV programs Provide medical oversight and safety leadership for assigned clinical trials, including medical monitoring and safety review activities Support business development efforts through proposal review, budget input, and participation in sponsor and bid pursuit meetings Lead and support critical safety activities including SAE/SUSAR review, DSMBs, dose escalation meetings, and protocol deviation oversight Review and ensure scientific integrity and medical consistency across key trial documents including protocols, ICFs, CSRs, DSURs, and PSURs Mentor cross‑functional teams and provide therapeutic expertise to internal stakeholders, investigators, and clients throughout study execution Requirements MD or PhD required Minimum 5‑10 years of relevant work experience, including at least 5 years of clinical development experience Infectious Disease expertise required Good standing with local, state (in the US), and national licensing and regulatory authorities and certifying bodies GDPR/HIPAA, CFR/CTR/CTD and applicable (local) regulatory requirements #J-18808-Ljbffr
