Location: Basel

Workload: 100%
Senior Medical Director with 8+ years of experience in clinical drug development, responsible for leading and supporting global, registration-track clinical trials for rare diseases. This role acts as a key member of the interdisciplinary development team, reporting directly to the Head of Clinical Development, with high visibility and hands-on leadership responsibility across study design, execution, and interpretation.

Your Tasks:

• Lead and contribute to clinical development activities as both individual contributor and functional leader
• Define, create, and drive the Clinical Development Plan (CDP), integrating regulatory, safety, and timeline considerations in collaboration with cross-functional teams
• Lead the design, execution, and interpretation of global clinical trials, including rare disease studies
• Author and review key clinical documents including study protocols, protocol amendments, SAPs, clinical study reports, and regulatory submission documents
• Provide medical oversight and sponsor oversight of CROs and vendors, ensuring subject safety, data integrity, and trial quality
• Perform trial medical monitoring or provide medical oversight across assigned studies
• Assess clinical data and study results, evaluate impact on development strategy, and present conclusions to senior management
• Support responses to health authority requests and contribute to regulatory documentation such as DSURs and safety reports
• Train and guide internal teams, CROs, and investigators on protocol and medical aspects of the studies
• Act as a clinical and therapeutic area expert within cross-functional teams
• Participate in interactions with regulatory authorities, ethics committees, and external agencies
• Support investigator-initiated studies and external research collaborations aligned with the clinical development strategy
• Contribute to scientific communication activities including publications and conference presentations
• Represent the organization at investigator meetings, scientific congresses, and external partner discussions

Your Profile:

• MD with Minimum 8 years of experience in clinical drug development within biotech or pharmaceutical environments
• Proven experience designing, conducting, and analyzing registration-track global clinical trials
• Strong preference for experience in rare disease clinical development
• Solid understanding of clinical research methodology and biostatistics, with the ability to interpret efficacy and safety data
• Demonstrated experience authoring and reviewing clinical trial protocols and regulatory documents
• Experience interacting with regulatory authorities and ethics committees
• Prior oversight of CROs and external vendors
• Board certification (or equivalent) in Gastroenterology, Hepatology, Internal Medicine, Pediatrics, or another relevant specialty preferred, but not mandatory

Please apply directly online with your CV.

**Please only apply if you are eligible to work in Switzerland and the EU *
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