Randstad Deutschlandweit vor 4 Wochen

Senior Medical Director - Clinical Developement

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bJobdescription /bbr /pFor our client, a dynamic international biotechnology company focused on clinical-stage development, we recruit a: /ppSenior/Executive Medical Director - Clinical Developementbr /Location: Based in Basel, Switzerland / Remote model /ppResponsibilities: /pulliLead Clinical Development: Provide clinical and general medical expertise throughout the entire development process, ranging from the clinical development plan and protocol development to study conduct, regulatory submission(s), and product launch. /liliProtocol Oversight: Provide expert input to clinical studies and oversee protocol development in collaboration with the partner’s global teams. /liliRegional Strategy: Take responsibility for protocols to identify region-specific operational issues for the territory and provide medical oversight of clinical projects where necessary. /liliCRO Management: Act as the medical monitor or provide oversight for CRO partners regarding medical queries and issues. /liliRegulatory Interaction: Provide medical expertise during interactions with regulatory agencies. /liliVendor Oversight: Oversee vendors as needed to ensure clinical studies successfully meet regulatory submission goals. /liliExternal Engagement: Attend investigator meetings and deliver clinical presentations as needed.

Proactively identify key investigators in the region to cultivate long-term collaborations, and recruit/manage a regional Clinical Advisory Board if needed. /liliRelationship Building: Establish and maintain appropriate collaborations and relationships with external scientific experts, thought leaders, and the general medical community. /li /ul pYour Background: /pulliEducation: Medical Doctor degree or Master degree in a relevant therapeutic area. /liliTherapeutic Focus: Relevant areas include Non-oncology, CV, Immunology, Special, Obesity, CNS, Muscle, etc.. /liliExperience: At least 5-10 years of experience in clinical development or a pharmaceutical medical function. /liliRegulatory Experience: Previous experience in IND/NDA submission and interacting with regulatory authorities is preferred. /liliSoft Skills: Good communication skills and presentation skills. /liliLanguages: Fluent in English (written and verbal). /li /ul

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