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CLINICAL TRIAL PHYSICIAN- NEUROLOGY
To join the team of Medical Directors in US.
The Clinical Trial Physician will be responsible for providing medical support and medical advice for clinical trials and safety evaluation within the department.
- Provide medical leadership to the study teams ,including creating clinical trial protocols while implementing the latest scientific information.
- Contribute to site selection.
- Contribute to review and approval of study protocols and amendments.
- Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviation decisions and other clinical documents as required for the conduct of clinical trials.
- Real time Medical Monitoring of clinical studies: ensure medical validity of each individual primary endpoint as well study subject safety.
- Pro-active escalation and correction of issues in consultation with the Global Medical Indication Lead.
- Interpret the clinical trial data for regulatory documents (e.g. CSR, INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications.
- Medical point of contact for all internal and external stakeholders.
Neurology, Physician, Clinical trial, Clinical research, Monitoring, clinical development, pharmaceutical, neuroscience, NDA, Medical, Drug safety, Regulatory Documents, Scientific Information
Additional Skills & Qualifications
- MD, MB/BS or equivalent degree and strong medical knowledge, proven clinical experience managing Neurology patients in hospital practice.
- Formal Neurologist specialty training (i.e., Fellowship).
- Significant neurology clinical drug development experience within pharmaceutical industry.
- Fluent in spoken and written English.
- Experience with NDA (New Drug Application) process.
- Solid understanding of regulatory guidelines for adverse event reporting.
- Strong communication & presentation skills and is a strong team player.
- Expert Level