Deciphera Pharmaceuticals, Inc
Director, Clinical Operational Excellence
Deciphera Pharmaceuticals, Inc, Waltham, Massachusetts, United States, 02254
Director, Clinical Operational Excellence
Full-timeWork Type: Full timeJob Location: On-Site WalthamDeciphera 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.The
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.The Role:Lead the internal Cross Functional Trial Teams in the establishment of Risk Based Quality Management best practices.Establish a framework for collecting clinical trial performance metrics to manage CROs and vendors.Drive clinical operations innovation through identification and implementation of new technologies and processes.Manage the eTMF for internally managed clinical trials.What You’ll Do:Drive project risk analysis and develop solutions to complex problems.Provide advice, identify issues, analyze trends, and implement standardized quality metrics.Contribute to the development and implementation of operational plans ensuring consistency across teams.Deliver expertise in the evaluation and management of Global Contract Research Organizations (CROs).Compare industry benchmarking performance insights to internal metrics.Manage Cross Functional TMF compliance activities.Lead the development of best practices concerning quality and compliance.Maintain awareness of existing and new regulations pertaining to GCP, ICH, etc.Responsible for hiring, training, and mentoring trial team staff.Lead initiatives to make Deciphera clinical trials patient and site-centric.Demonstrate excitement around the Vision and Mission of Deciphera.Other duties as assigned.What You’ll Bring:Bachelor’s degree in health science or related field.Excellent communication, organizational, and problem-solving skills.Strong attention to detail.Expertise in clinical development process and global regulatory requirements.Strong leadership and interpersonal skills.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.Advanced degree preferred.Deciphera 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 shutdownsMonthly cell phone stipendMedical, Dental, and Vision Insurance401(k) retirement plan with company matchLife and Supplemental life insuranceShort and Long Term Disability insuranceHealth savings account with company contributionGenerous parental leave
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Full-timeWork Type: Full timeJob Location: On-Site WalthamDeciphera 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.The
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.The Role:Lead the internal Cross Functional Trial Teams in the establishment of Risk Based Quality Management best practices.Establish a framework for collecting clinical trial performance metrics to manage CROs and vendors.Drive clinical operations innovation through identification and implementation of new technologies and processes.Manage the eTMF for internally managed clinical trials.What You’ll Do:Drive project risk analysis and develop solutions to complex problems.Provide advice, identify issues, analyze trends, and implement standardized quality metrics.Contribute to the development and implementation of operational plans ensuring consistency across teams.Deliver expertise in the evaluation and management of Global Contract Research Organizations (CROs).Compare industry benchmarking performance insights to internal metrics.Manage Cross Functional TMF compliance activities.Lead the development of best practices concerning quality and compliance.Maintain awareness of existing and new regulations pertaining to GCP, ICH, etc.Responsible for hiring, training, and mentoring trial team staff.Lead initiatives to make Deciphera clinical trials patient and site-centric.Demonstrate excitement around the Vision and Mission of Deciphera.Other duties as assigned.What You’ll Bring:Bachelor’s degree in health science or related field.Excellent communication, organizational, and problem-solving skills.Strong attention to detail.Expertise in clinical development process and global regulatory requirements.Strong leadership and interpersonal skills.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.Advanced degree preferred.Deciphera 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 shutdownsMonthly cell phone stipendMedical, Dental, and Vision Insurance401(k) retirement plan with company matchLife and Supplemental life insuranceShort and Long Term Disability insuranceHealth savings account with company contributionGenerous parental leave
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