Deciphera Pharmaceuticals, Inc
Associate Director, Clinical Operations
Deciphera Pharmaceuticals, Inc, Waltham, Massachusetts, United States, 02254
Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.Enabled by our proprietary drug discovery platform, Deciphera has developed a diverse pipeline of wholly-owned drug candidates. QINLOCK (ripretinib) is Deciphera’s switch control inhibitor developed for the treatment of fourth-line GIST. QINLOCK is approved in Australia, Canada, China, the European Union, Hong Kong, Switzerland, Taiwan, the United States, and the United Kingdom. We wholly own QINLOCK and all of our drug candidates with the exception of a development and commercialization out-license agreement for QINLOCK in Greater China. In addition to QINLOCK, we have identified and advanced multiple product candidates from our platform into clinical studies, including vimseltinib and DCC-3116.Job Description
The Role:The Associate Director, Clinical Operations is responsible for the successful execution of clinical trials from protocol conception through the clinical study report. The Senior Clinical Project Manager ensures completion of study deliverables and proactively identifies and resolves clinical project issues.What You’ll Do:Demonstrated leadership in the planning, execution and completion of clinical trialsProactively identifies and resolves operational issues/processes to ensure achievement of study milestones, data quality and date integrityAccountable for oversight of the setup, maintenance, and close out of the Trial Master FileInteracts with and participates in strategy discussions with other functional areas to support clinical trial activitiesParticipates in the selection and oversight of CROs and vendorsResponsible for assuring compliance with internal SOPs, FDA regulations and GCPMay participate in the preparation, review, updating and training of SOPsAssist in the creation and management of program level budget with Director, Clinical OperationsMay contribute to the strategic development of the programSupport/may lead department initiatives and process improvementsPresent on-going study updates to Clinical LeadershipServe as a leadership role model within the clinical operations departmentDemonstrates excitement around the Vision and Mission of Deciphera and the clinical operations departmentOther duties as assignedQualifications
Bachelor’s degree in health science or related fieldMinimum of 8 years in clinical trial managementExcellent communication (oral and written), organizational, and problem-solving skillsStrong attention to detailComprehensive knowledge in clinical development process (Phase 1-3), global regulatory requirement, ICH guidelines, GCP and guidelines for clinical trialsExcellent leadership, interpersonal, communication, planning and organizational skillsDemonstrated ability to identify and resolve issues
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The Role:The Associate Director, Clinical Operations is responsible for the successful execution of clinical trials from protocol conception through the clinical study report. The Senior Clinical Project Manager ensures completion of study deliverables and proactively identifies and resolves clinical project issues.What You’ll Do:Demonstrated leadership in the planning, execution and completion of clinical trialsProactively identifies and resolves operational issues/processes to ensure achievement of study milestones, data quality and date integrityAccountable for oversight of the setup, maintenance, and close out of the Trial Master FileInteracts with and participates in strategy discussions with other functional areas to support clinical trial activitiesParticipates in the selection and oversight of CROs and vendorsResponsible for assuring compliance with internal SOPs, FDA regulations and GCPMay participate in the preparation, review, updating and training of SOPsAssist in the creation and management of program level budget with Director, Clinical OperationsMay contribute to the strategic development of the programSupport/may lead department initiatives and process improvementsPresent on-going study updates to Clinical LeadershipServe as a leadership role model within the clinical operations departmentDemonstrates excitement around the Vision and Mission of Deciphera and the clinical operations departmentOther duties as assignedQualifications
Bachelor’s degree in health science or related fieldMinimum of 8 years in clinical trial managementExcellent communication (oral and written), organizational, and problem-solving skillsStrong attention to detailComprehensive knowledge in clinical development process (Phase 1-3), global regulatory requirement, ICH guidelines, GCP and guidelines for clinical trialsExcellent leadership, interpersonal, communication, planning and organizational skillsDemonstrated ability to identify and resolve issues
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