Das ist der Job
CRO Management: Act as the medical monitor or provide oversight for CRO partners regarding medical queries and issues.
Darum lohnt es sich
Jobdescription For our client, a dynamic international biotechnology company focused on clinical-stage development, we recruit a: Senior/Executive Medical Director - Clinical Developement Location: Based in Basel, Switzerland / Remote model Responsibilities: Lead 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.
Protocol Oversight: Provide expert input to clinical studies and oversee protocol development in collaboration with the partner's global teams. Regional Strategy: Take responsibility for protocols to identify region-specific operational issues for the territory and provide medical oversight of clinical projects where necessary.
Regulatory Interaction: Provide medical expertise during interactions with regulatory agencies. Vendor Oversight: Oversee vendors as needed to ensure clinical studies successfully meet regulatory submission goals. External 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. Relationship Building: Establish and maintain appropriate collaborations and relationships with external scientific experts, thought leaders, and the general medical community.
Your Background: Education: Medical Doctor degree or Master degree in a relevant therapeutic area. Therapeutic Focus: Relevant areas include Non-oncology, CV, Immunology, Special, Obesity, CNS, Muscle, etc Experience: At least 5-10 years of experience in clinical development or a pharmaceutical medical function.
Regulatory Experience: Previous experience in IND/NDA submission and interacting with regulatory authorities is preferred. Soft Skills: Good communication skills and presentation skills. Languages: Fluent in English (written and verbal).
