Das ist der Job
Lead clinical development.
Darum lohnt es sich
Provide expert input to the clinical studies and provide oversight of protocol development, in collaboration with partner’s global teams Responsible for protocols to identify region-specific operational issues for the territory.
Provide clinical as well as general medical expertise throughout developments, from clinical development plan, protocol development through study conduct, regulatory submission(s) and product launch.
Where necessary, provide medical oversight of clinical projects Perform as medical monitor or oversight for CRO partners on medical queries and issues Provide medical expertise in interactions with regulatory agencies Attend investigator meetings; deliver clinical presentations as needed Oversight vendors as needed to ensure successful clinical studies for regulatory submission goal Proactively identify key investigators in the region and cultivate long-term collaborations.
Recruit and manage regional Clinical Advisory Board if needed Establish and maintain appropriate collaborations and relationships with external scientific experts, thought leaders, and the general medical community Qualification Medical Doctor degree or Master degree of relevant therapeutic area At least 3-5 years of clinical development or pharmaceutical medical function experience Previous experiences in IND/NDA submission and interacting with regulatory authorities preferred Good communication skills and presentation skills #J-18808-Ljbffr