Director, Clinical Operational Excellence

Company DescriptionDeciphera, a member of ONO, 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.  See here for more details on our portfolio.We offer an outstanding culture and opportunity for personal and professional growth guided by our “PATHS” Core Values and how we work together. We are proud to be Great Place to Work Certified 2023 and rank #25 on Fortune’s Best Places to Work Small and Midsized Biotech Companies in 2023. Find more details about our award-winning culture here.Job DescriptionThe Director, Clinical Operational Excellence is responsible for leading a Center of Excellence aimed at improving the operational performance and quality of all clinical trials sponsored by Deciphera Pharmaceuticals.Lead the internal Cross Functional Trial Teams in the establishment of Risk Based Quality Management best practices.  Works with all functions to ensure compliant risk management best practices are deployed, and monitoredEstablish a framework for collecting clinical trial performance metrics to be used in the management of CROs and vendors working on Deciphera-sponsored trials.  Performance metrics will be used to benchmark individual clinical trial performance, whether the trial is insourced or outsourced and to establish a comparison against industry benchmarks.Drives clinical operations innovation though the process of identification and implementation of new technologies, processes and process improvement initiatives.Drives the outsourcing and/or management of the eTMF for internally managed clinical trialsWhat You’ll Do:Drives project risk analysis and develops solutions to a variety of complex problems. Ensures that Clinical Trial Teams proactively identify and manage risks through the use of risk identification, risk monitoring techniques and the implementation of Quality Tolerance Limits according to ICH E6(R2).Provides advice, identifies issues, analyzes trends, implements standardized quality metrics, deploys compliance measures, identifies quality risks and events with each trial team, generates and facilitates Corrective Action/Preventive Action (CAPA), etc. Contributes to the development (content) and implementation (execution) of standards of all study-related operational plans (e.g., manuals, trackers, processes, etc.) ensuring a “fit for purpose” and consistency/standardization between teams to be deployed within each clinical trial team.Delivers Clinical Operations expertise and strategic leadership in the evaluation, selection, oversight and management of Global Contract Research Organizations (CROs) and other external vendors.Compares industry standard benchmarking performance insights and analytics to Deciphera internal metrics (e.g., OKMs/KPIs/KQIs/KRIs) to be used by study management and Vendor Performance and Strategy to monitor and improve clinical trial and vendor performance.Manage Cross Functional TMF compliance related activities inclusive of holistic evaluation of TMF Health and TMF inspection readiness support.Leads the development, enhancement and implementation of best practices concerning quality and compliance by building quality into internal processes leading to a state of constant inspection readiness.  Acts as an internal SME for quality-related matters.Maintain awareness of existing and new internal and external regulations and guidance pertaining to GCP, ICH, data integrity, system validation etc. assessing impact and providing recommendations where requiredWhen applicable - Responsible for hiring, training, mentoring trial team staff.   Including hiring, performance management, retention, and engagement as well as succession planningLeads and implements a culture to making Deciphera clinical trials patient and site centric through the identification, evaluation and recommendation of innovative ideas and technologies.Demonstrates excitement around the Vison and Mission of Deciphera and the departmentOther duties as assignedQualificationsWhat You’ll Bring:Bachelor’s degree in health science or related fieldExcellent communication (oral and written), organizational, and problem-solving skillsExcellent Microsoft Office skillsStrong attention to detailExpertise in clinical development process (Phase 1-3), global regulatory requirements and guidelines for clinical trialsExtensive CRO/vendor management experienceExcellent leadership, interpersonal, communication, planning and organizational skillsEstablished ability to manage and demonstrated ability to identify and resolve issuesStrong oncology and other therapeutic area knowledge as well as global experienceMinimum of 5 years in clinical trial managementAbility to travel approximately 20%Preferred Qualifications:Greater than 10 years in clinical operations and/or trial management, managing complex clinical development programs.Advanced degree preferred.Additional InformationDeciphera offers a comprehensive benefits package that includes but is not limited to the following:Non-accrual paid time offSummer vacation bonusGlobal, company-wide summer and winter shutdownsAn annual lifestyle allowanceMonthly cell phone stipendInternal rewards and recognition programMedical, Dental, and Vision Insurance401(k) retirement plan with company matchLife and Supplemental life insurance for familyShort and Long Term Disability insuranceHealth savings account with company contributionFlexible spending account for either health care and/or dependent care.Family planning benefitGenerous parental leave[if applicable] Car allowanceDeciphera, a member of ONO, is a company headquartered in Waltham, Massachusetts. Our state-of-the-art research facility is located in Lawrence, Kansas and our European operations are run out of Switzerland.EQUAL EMPLOYMENT OPPORTUNITY INFORMATIONDeciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process and has no effect on your opportunity for employment. This information will also be treated confidentially.  Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis.EQUAL EMPLOYMENT OPPORTUNITY INFORMATIONDeciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially.  Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis.SummaryType: Full-timeFunction: ScienceExperience level: DirectorIndustry: Pharmaceuticals