Director, Clinical Operational Excellence

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.Key Responsibilities : 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 monitored.Establish 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 through 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 trials.What 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 required.When applicable - Responsible for hiring, training, mentoring trial team staff. Including hiring, performance management, retention, and engagement as well as succession planning.Leads 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 Vision and Mission of Deciphera and the department.Other duties as assigned.Qualifications What You’ll Bring : Bachelor’s degree in health science or related field.Excellent communication (oral and written), organizational, and problem-solving skills.Excellent Microsoft Office skills.Strong attention to detail.Expertise in clinical development process (Phase 1-3), global regulatory requirements, and guidelines for clinical trials.Extensive CRO / vendor management experience.Excellent leadership, interpersonal, communication, planning, and organizational skills.Established ability to manage and demonstrated ability to identify and resolve issues.Strong oncology and other therapeutic area knowledge as well as global experience.Minimum of 5 years in clinical trial management.Ability 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 Information Benefits : Competitive salary and annual bonus.Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.Generous parental leave and family planning benefits.Outstanding culture and opportunities for personal and professional growth.Apply Now : Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team!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.#J-18808-Ljbffr