Senior Medical Director / Executive Medical Director
New
A
AllucentPharmaceutical, Biotech, CRO
United StatesFull-TimeDirector
Salary not disclosed
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Job Details
- Experience
- 5-10 years of relevant work experience, including at least 5 years of clinical development experience
- Required Skills
- HIPAA
Requirements
- MD or PhD degree
- Minimum 5-10 years of relevant work experience
- At least 5 years of clinical development experience
- Expertise in Infectious Disease
- Good standing with local, state (in the US), and national licensing and regulatory authorities
- Knowledge of GDPR/HIPAA, CFR/CTR/CTD and applicable regulatory requirements
- Executive presence and ability to build relationships with sponsors
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
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