Medical Director for Infectious Disease Clinical Development
1 month ago
Immunocore is seeking a highly skilled Medical Director for Infectious Disease Clinical Development to lead our clinical development strategy and plans. As a key member of our team, you will work closely with Development and Discovery Program Leads and counterparts in Regulatory, Clinical Development, Clinical Operations, Biostatistics, Clinical Pharmacology, Non-clinical and Discovery Research for assigned studies.
Key Responsibilities:- Develop and implement comprehensive clinical development plans that meet ethical, scientific, safety, and regulatory objectives.
- Provide medical oversight of assigned clinical studies, including implementation, medical/safety monitoring, protocol compliance, and medical data review.
- Work with Pharmacovigilance team to identify and communicate emergent safety signals and trends to the clinical project teams and senior management.
- Contribute to the regulatory strategy, preparation, and review of regulatory submissions, response to IRB/EC questions, and participate in global health agency meetings.
Requirements:
- MD or MD/PhD with research training.
- Strong understanding of pharmacokinetics, biomarkers, statistical principles, and regulatory requirements.
- At least 3 years of relevant experience in clinical drug development across academia or pharmaceutical industry.
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