Gilead Sciences, Inc.
Senior Director, Clinical Data Management
Gilead Sciences, Inc., Santa Monica, California, United States, 90403
Senior Director, Clinical Data Management
Locations: United States – Remote, United States - California - Santa MonicaTime Type: Full timePosted on: Posted 4 Days AgoJob Requisition ID: R0042896We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.The Senior Director, Clinical Data Management will report to the ED, Clinical Compliance and Data Management of Kite and will lead and manage the function of Data Management. You will also mentor, instruct and manage full time employees and sponsor multiple contracting employees. This leadership role involves strategic and tactical capabilities, but also excellence in business processes. You will work closely with leaders in cross functions including but not limited to Biostatistics, Statistical Programming, Clinical Operations, Clinical Development, Safety, Manufacturing, Translational Science and Quality. This role will function as the company’s Global Head of Data Management, which provides database programming, data collection, data review, data processing and extractions for planned and ad hoc data analysis for all clinical studies within the clinical development function. The scope of responsibilities includes but is not limited to leadership, policy-making, global infrastructure development, personnel development, training and oversight, vendor oversight and regulatory guidance within the function.Job ResponsibilitiesOversee all aspects of the Data Management and Clinical Programming teams including resource planning, deliverables, staff training, staff appraisals, performance reviews, and annual salary reviews.Develop Data Management Departmental SOPs and ensure staff adherence to company policies, SOPs, federal guidelines and GCPs.Forecast and manage the department budget both for external and internal spend.Work closely with Quality and Clinical Compliance to ensure quality and continuous process improvement within clinical trial data management.Effectively represent Data Management departments at project review meetings, quality review meetings, and other stakeholder meetings.Lead and provide oversight for the execution of data management for all programs and studies of the company and accountable for all data management and clinical programming activities.Accountable for delivery of departmental infrastructure projects.Responsible for managing a highly effective team of Managers and Clinical Data Associates supporting highly complex clinical data management.Has extensive knowledge and understanding of the business beyond the functional area.Responsible for instructing the implementation of new or advanced systems, processes and resources to increase productivity.Guides data management activities for regulatory submissions.Guides CDM organizational strategy and implements departmental change.Basic QualificationsDoctorate and 10+ years of data management experienceORMaster’s and 12+ years of data management experienceORBachelor’s and 14+ years of data management experienceORHigh School Diploma/GED and 18+ years of data management experiencePreferred Qualifications16 years of experience in clinical data management in pharmaceutical industry.Scientific career background.Experience in oncology therapeutic area; cellular therapy in oncology experience.12 years of managerial experience in data management function and experience in leading mid- to large group of data managers.Experience in clinical trial database build, case report form design and familiar with CDISC and regulatory requirements.Excellent oral and written communication skills, project and personnel management skills and organizational skills.The work you do at Kite will help change how cancer is treated and ensure patients and their families have more time together. Ready to create more tomorrows with us? Hit apply.The salary range for this position is: $216,070.00 - $279,620.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA.As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.
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Locations: United States – Remote, United States - California - Santa MonicaTime Type: Full timePosted on: Posted 4 Days AgoJob Requisition ID: R0042896We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.The Senior Director, Clinical Data Management will report to the ED, Clinical Compliance and Data Management of Kite and will lead and manage the function of Data Management. You will also mentor, instruct and manage full time employees and sponsor multiple contracting employees. This leadership role involves strategic and tactical capabilities, but also excellence in business processes. You will work closely with leaders in cross functions including but not limited to Biostatistics, Statistical Programming, Clinical Operations, Clinical Development, Safety, Manufacturing, Translational Science and Quality. This role will function as the company’s Global Head of Data Management, which provides database programming, data collection, data review, data processing and extractions for planned and ad hoc data analysis for all clinical studies within the clinical development function. The scope of responsibilities includes but is not limited to leadership, policy-making, global infrastructure development, personnel development, training and oversight, vendor oversight and regulatory guidance within the function.Job ResponsibilitiesOversee all aspects of the Data Management and Clinical Programming teams including resource planning, deliverables, staff training, staff appraisals, performance reviews, and annual salary reviews.Develop Data Management Departmental SOPs and ensure staff adherence to company policies, SOPs, federal guidelines and GCPs.Forecast and manage the department budget both for external and internal spend.Work closely with Quality and Clinical Compliance to ensure quality and continuous process improvement within clinical trial data management.Effectively represent Data Management departments at project review meetings, quality review meetings, and other stakeholder meetings.Lead and provide oversight for the execution of data management for all programs and studies of the company and accountable for all data management and clinical programming activities.Accountable for delivery of departmental infrastructure projects.Responsible for managing a highly effective team of Managers and Clinical Data Associates supporting highly complex clinical data management.Has extensive knowledge and understanding of the business beyond the functional area.Responsible for instructing the implementation of new or advanced systems, processes and resources to increase productivity.Guides data management activities for regulatory submissions.Guides CDM organizational strategy and implements departmental change.Basic QualificationsDoctorate and 10+ years of data management experienceORMaster’s and 12+ years of data management experienceORBachelor’s and 14+ years of data management experienceORHigh School Diploma/GED and 18+ years of data management experiencePreferred Qualifications16 years of experience in clinical data management in pharmaceutical industry.Scientific career background.Experience in oncology therapeutic area; cellular therapy in oncology experience.12 years of managerial experience in data management function and experience in leading mid- to large group of data managers.Experience in clinical trial database build, case report form design and familiar with CDISC and regulatory requirements.Excellent oral and written communication skills, project and personnel management skills and organizational skills.The work you do at Kite will help change how cancer is treated and ensure patients and their families have more time together. Ready to create more tomorrows with us? Hit apply.The salary range for this position is: $216,070.00 - $279,620.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA.As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.
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