Serves as medical monitor providing medical support and guidance in investigator selection, study design, data collection, and study conduct, patient/subject safety or oversees CRO medical monitor. Reviews safety and efficacy data, being able to interpret them in light of the indication and the proposed mechanism of action of the study drug(s) involved and make recommendations as to what appropriate steps need to be taken. Trains and mentors clinical study staff in the clinical aspects of the product and its indications. Is responsible for writing a short summary of results following study readout.
Leads cross-functional teams in a matrix environment, provide input to the clinical development plan and will provide medical leadership for assigned disease strategy.
Works closely with other functional areas such as commercial, regulatory, pharmacovigilence, pre-clinical development and translational medicine in this regard.
Responsible for the clinical/medical leadership of INDs, NDAs, BLAs and other global regulatory filings. Provides medical leadership and expertise in meetings with regulatory.
Must speak fluid English
- Pharmaceutical industry experience with 3 years of experience developing and directing clinical trials.
- Completed Medical Training
- Abililty to interface professionally with a wide spectrum of internal and external academicians, agencies and industry executives in the scientific/medical arena.
- Strong presentation and communication skills.
- Ability to work on multiple projects with aggressive timelines.
- Must work independently, without daily direction.
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