Job description
For our client, a dynamic international biotechnology company focused on clinical-stage development, we recruit a:
Senior/Executive Medical Director - Clinical Development
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.
* CRO Management: Act as the medical monitor or provide oversight for CRO partners regarding medical queries and issues.
* 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).
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