Anmelden
Registrieren
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.
- 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).
