Dragonfly Therapeutics, Inc.
Director of Clinical Outsourcing
Dragonfly Therapeutics, Inc., Waltham, Massachusetts, United States, 02254
Director of Clinical Outsourcing
Dragonfly Therapeutics is seeking a knowledgeable, experienced, and motivated individual to join our Clinical Operations team. Reporting to the VP of Clinical Development Operations, this individual will be responsible for activities related to the outsourcing of clinical services including negotiation and maintenance of contracts and study budgets. The candidate must possess a strong understanding of Clinical Operations processes and provide vendor outsourcing expertise.
Responsibilities (including but not limited to):Serve as the primary contact with clinical CROs, partners, vendors, consultants, and other stakeholders to address issues, and function as a liaison with these parties on contract deliverablesManage the identification and selection process of clinical vendorsOversee the request for proposal process including bid comparison, bid review meetings, recommendation on selection and awarding the serviceManage work order amendments and change orders to ensure appropriate pricing and timely executionLead vendor governance meetings with key CRO and vendor partnershipsReviews metrics and Key Performance Indicators (KPIs) to ensure oversight of clinical trial progress and participates in quality review of vendor performanceCollaborate effectively with all relevant functional departments (e.g., Quality Assurance, Legal, Finance) to ensure appropriate review and approval of clinical vendors and vendor contractsSupport the development and maintaining clear documentation including RFP templates, Change Order and Change Notification Form trackers, Confidentiality Agreements (CDAs), Master Service Agreements (MSAs) and project-specific agreements as assignedIdentify improvement projects within Clinical Operations and the broader Clinical Development teamMaintain project-level financial management, including budgeting, monthly forecasting and accruals and invoice reconciliationQualifications
BA/BS/MS and 10+ years directly related experience in clinical operations and contract managementIn-depth knowledge and understanding of all aspects of clinical trial management, with a track record of successfully negotiating and managing CRO contracts, schedules and budgetsProficient in the end-to-end clinical sourcing and contracting process, with proven experience in vendor and contract management with a sponsor company or CRO managing various phase clinical trialsMicrosoft Offices skill proficiency in (Word, Excel, PowerPoint, Outlook)Proven track record of leadership and operational excellence requiredExcellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environmentExcellent communications skills and ability to influence across multiple functions
About Dragonfly
Dragonfly Therapeutics is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing therapies that use its novel multispecific antibody technology to harness the body's immune system to bring breakthrough treatments to patients. In addition to its wholly owned clinical assets, Dragonfly has a deep pipeline of wholly owned preclinical candidates discovered using its proprietary platform, as well as productive collaborations with Merck, AbbVie, Gilead and Bristol Myers Squibb in a broad range of disease areas.
Our mission is to revolutionize disease treatment by inventing natural killer cell-based therapies for vastly improved patient outcomes. We believe in a small team with a big impact.
Dragonfly Therapeutics is seeking a knowledgeable, experienced, and motivated individual to join our Clinical Operations team. Reporting to the VP of Clinical Development Operations, this individual will be responsible for activities related to the outsourcing of clinical services including negotiation and maintenance of contracts and study budgets. The candidate must possess a strong understanding of Clinical Operations processes and provide vendor outsourcing expertise.
Responsibilities (including but not limited to):Serve as the primary contact with clinical CROs, partners, vendors, consultants, and other stakeholders to address issues, and function as a liaison with these parties on contract deliverablesManage the identification and selection process of clinical vendorsOversee the request for proposal process including bid comparison, bid review meetings, recommendation on selection and awarding the serviceManage work order amendments and change orders to ensure appropriate pricing and timely executionLead vendor governance meetings with key CRO and vendor partnershipsReviews metrics and Key Performance Indicators (KPIs) to ensure oversight of clinical trial progress and participates in quality review of vendor performanceCollaborate effectively with all relevant functional departments (e.g., Quality Assurance, Legal, Finance) to ensure appropriate review and approval of clinical vendors and vendor contractsSupport the development and maintaining clear documentation including RFP templates, Change Order and Change Notification Form trackers, Confidentiality Agreements (CDAs), Master Service Agreements (MSAs) and project-specific agreements as assignedIdentify improvement projects within Clinical Operations and the broader Clinical Development teamMaintain project-level financial management, including budgeting, monthly forecasting and accruals and invoice reconciliationQualifications
BA/BS/MS and 10+ years directly related experience in clinical operations and contract managementIn-depth knowledge and understanding of all aspects of clinical trial management, with a track record of successfully negotiating and managing CRO contracts, schedules and budgetsProficient in the end-to-end clinical sourcing and contracting process, with proven experience in vendor and contract management with a sponsor company or CRO managing various phase clinical trialsMicrosoft Offices skill proficiency in (Word, Excel, PowerPoint, Outlook)Proven track record of leadership and operational excellence requiredExcellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environmentExcellent communications skills and ability to influence across multiple functions
About Dragonfly
Dragonfly Therapeutics is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing therapies that use its novel multispecific antibody technology to harness the body's immune system to bring breakthrough treatments to patients. In addition to its wholly owned clinical assets, Dragonfly has a deep pipeline of wholly owned preclinical candidates discovered using its proprietary platform, as well as productive collaborations with Merck, AbbVie, Gilead and Bristol Myers Squibb in a broad range of disease areas.
Our mission is to revolutionize disease treatment by inventing natural killer cell-based therapies for vastly improved patient outcomes. We believe in a small team with a big impact.