Sr. Director, Clinical Development Oncology

h3About this position /h3pThe Senior Director, Clinical Development is responsible for providing medical leadership and strategic input across the clinical development programs of the company. Reporting to the Vice President, Clinical Development, the incumbent will contribute to the design, execution, monitoring, analysis, and reporting of clinical studies, ensuring scientific integrity, patient safety, and regulatory compliance. /ppbYour tasks: /b /ppbClinical Development Strategy /b /pullipContribute to the development and execution of clinical development strategies aligned with corporate objectives. /p /lilipProvide medical and scientific leadership for assigned clinical programs from early-stage development through late-stage clinical trials. /p /lilipSupport the preparation of Clinical Development Plans, Target Product Profiles, and regulatory strategies. /p /lilipEvaluate emerging scientific and clinical data to inform program decisions. /p /li /ulpbClinical Trial Design and Execution /b /pullipServe as Medical Monitor for clinical studies, ensuring patient safety and protocol compliance. /p /lilipContribute to the design and review of clinical study protocols, investigator brochures, informed consent forms, and other clinical documents. /p /lilipParticipate in study start-up, execution, oversight, and close-out activities. /p /lilipReview and interpret clinical study data and support data review meetings. /p /lilipContribute to the identification and mitigation of clinical risks. /p /li /ulpbSafety Oversight /b /pullipReview and assess serious adverse events (SAEs) and adverse events of special interest. /p /lilipCollaborate with Pharmacovigilance to ensure appropriate safety monitoring and reporting. /p /lilipParticipate in safety review committees and data monitoring activities. /p /lilipSupport benefit-risk assessments throughout the development lifecycle. /p /li /ulpbRegulatory and Scientific Support /b /pullipContribute to regulatory submissions and interactions with global health authorities. /p /lilipSupport the preparation of briefing documents, clinical study reports, investigator brochures, and submission dossiers. /p /lilipProvide medical expertise during regulatory inspections and audits. /p /li /ulpbExternal Stakeholder Engagement /b /pullipEstablish and maintain productive relationships with investigators, key opinion leaders (KOLs), academic collaborators, and clinical trial sites. /p /lilipRepresent the company at scientific meetings, investigator meetings, advisory boards, and industry conferences. /p /lilipSupport publication planning and presentation of clinical data. /p /li /ulpbCross-Functional Collaboration /b /pullipWork closely with Clinical Operations to ensure efficient trial conduct. /p /lilipCollaborate with Biostatistics and Data Management on data analyses and interpretation. /p /lilipPartner with Translational Medicine and Biomarker teams to integrate scientific insights into clinical development. /p /lilipProvide medical input to Medical Affairs and Business Development activities as needed. /p /li /ulh3Role requirements /h3ullipMD or equivalent medical degree in addition to advanced knowledge and clinical training in medical/scientific area; Oncology clinical practice experience. /p /lilipMinimum 8 years of experience in clinical drug development within biotech, pharmaceutical, or academic settings. /p /lilipExperience serving as Medical Monitor in interventional clinical studies. /p /lilipDemonstrated involvement in the design and execution of Phase I-III clinical trials. /p /lilipExperience interacting with regulatory authorities is preferred. /p /lilipPrior experience in a small biotechnology company is advantageous. /p /lilipStrong knowledge of GCP, ICH guidelines, and global regulatory requirements. /p /lilipSolid understanding of clinical trial methodology, statistics, and data interpretation. /p /lilipExperience in protocol development and clinical study reporting. /p /lilipFamiliarity with pharmacovigilance and clinical safety processes. /p /lilipWork location: on site in Allschwil with up to 2 days home office. /p /li /ulh3Work permit /h3pCandidate needs to hold a Swiss work permit or be an EU citizen eligible to work in Switzerland. /p #J-18808-Ljbffr