54 days ago on sjobs.brassring.com

Clinical Trial Leader I, Translational Clinical Oncology

Novartis Pharma Schweiz AG

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Clinical Trial Leader I, Translational Clinical Oncology

Job ID194886BRPosition TitleClinical Trial Leader I, Translational Clinical OncologyDivisionNIBRBusiness UnitOncology NIBRCountrySwitzerlandWork LocationBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaResearch & DevelopmentTherapeutic/Disease AreaOncologyJob TypeFull TimeEmployment TypeRegularJob DescriptionAs Clinical Trial Leader I you will contribute to the NIBR drug discovery process with the goal to discover treatments for unmet medical needs which ultimately serve the patient

• Lead the clinical protocol development process in collaboration with the MD/Physician Clinical Program Leader (CPL): responsible author for clinical protocols, amendments and related documents; contribute to the medical/scientific input given for the development of trial-related documents and processes which reside in other line functions; obtain approval from internal review boards. Collaborate with the Medical Directors of the Novartis local organizations (CPOs) and investigators to ensure their feedback is adequately integrated into protocol
• Contribute to the development of clinical sections of regulatory documents
• Investigator/site relationship management is vital; you will develop effective working relationship with key investigators in assigned therapy area to optimize scientific quality/innovation of clinical study design, execution, reporting and publication. Contribute to trial-related advisory boards. Lead investigators meetings. Lead protocol training meetings and support CPOs in the conduct of regional meetings. You will be accountable for all internal clinical meetings
• Lead and matrix manage the global multidisciplinary Clinical Trial Team (CTT) to ensure all trial deliverables are met according to timelines, budget, and resource requirements; speak up against unrealistic timelines. Energize CTT to adhere to global performance and quality standards: chair CTT meetings, report study progress and issues with their resolution plan. Engage the input of line functions at the appropriate time. Lead trial level interactions with Global Monitoring Operations and other relevant functions
• In collaboration with the CPL, lead the clinical trial data ongoing medical/scientific review, final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations
• Prepare and run dose escalation meetings with investigators. Coordinate the real time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic and biomarker data, to provide consolidated information for dose escalation meetings with investigators
• Forecast trial resources needs (external costs): accountable for the development, management and tracking of trial budget working closely with CRO Management, with Clinical Trial Budget Managers and Translational Clinical Oncology Global Program Managers
• Sit on Early Program Team and contribute to program strategy
Minimum requirements• Advanced life sciences University degree: PhD preferred otherwise MSc
• Business-level/fluent English (oral and written)

• Approximately 4 years technical, operational and managerial experience in planning, executing, reporting and publishing early phase clinical studies in a Sponsor/Pharmaceutical company. (If no sponsor experience, than strong relevant Oncology early phase study expertise from a full-service Contract Research Organisation could be supported for an excellent candidate)
• Experienced in early phase clinical studies including dose escalation and First in Human. Used to authoring and reviewing protocols and reviewing patient data
• Good knowledge and experience of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and global clinical development process
• Strong communication, planning, prioritization, problem solving and organizational skills: success communicating with a broad range of stakeholders and building strong positive relationships
• Used to working in a multidisciplinary setting: strong cooperative team player, flexible and adapting to a changing environment
• Office and clinical trial software IT computer literacy

Additional preferred experience
• Oncology or Haematology early clinical development
• Phase III study experience (helpful as additional experience but not your main experience)