Senior Medical Director, Clinical Development
vor 12 Stunden
Senior Medical Director - Clinical Development Location: BaselContract: 6 months Start Date: ASAPWorkload: 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 leaderDefine, create, and drive the Clinical Development Plan (CDP), integrating regulatory, safety, and timeline considerations in collaboration with cross-functional teamsLead the design, execution, and interpretation of global clinical trials, including rare disease studiesAuthor and review key clinical documents including study protocols, protocol amendments, SAPs, clinical study reports, and regulatory submission documentsProvide medical oversight and sponsor oversight of CROs and vendors, ensuring subject safety, data integrity, and trial qualityPerform trial medical monitoring or provide medical oversight across assigned studiesAssess clinical data and study results, evaluate impact on development strategy, and present conclusions to senior managementSupport responses to health authority requests and contribute to regulatory documentation such as DSURs and safety reportsTrain and guide internal teams, CROs, and investigators on protocol and medical aspects of the studiesAct as a clinical and therapeutic area expert within cross-functional teams Participate in interactions with regulatory authorities, ethics committees, and external agenciesSupport investigator-initiated studies and external research collaborations aligned with the clinical development strategyContribute to scientific communication activities including publications and conference presentationsRepresent 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 environmentsProven experience designing, conducting, and analyzing registration-track global clinical trialsStrong preference for experience in rare disease clinical developmentSolid understanding of clinical research methodology and biostatistics, with the ability to interpret efficacy and safety dataDemonstrated experience authoring and reviewing clinical trial protocols and regulatory documentsExperience interacting with regulatory authorities and ethics committeesPrior oversight of CROs and external vendorsBoard 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 *headcount AG
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Clinical Development Medical Director
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