Senior Medical Director, Clinical Development
Job details
Contracting
Ref: BH-2311
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Senior Medical Director – Clinical Development
Location: Basel
Contract: 6 months
Start Date: ASAP
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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