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Director of Clinical Outsourcing

Waltham, Massachusetts, United States

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 deliverables
  • Manage the identification and selection process of clinical vendors
  • Oversee the request for proposal process including bid comparison, bid review meetings, recommendation on selection and awarding the service
  • Manage work order amendments and change orders to ensure appropriate pricing and timely execution
  • Lead vendor governance meetings with key CRO and vendor partnerships
  • Reviews metrics and Key Performance Indicators (KPIs) to ensure oversight of clinical trial progress and participates in quality review of vendor performance
  • Collaborate effectively with all relevant functional departments (e.g., Quality Assurance, Legal, Finance) to ensure appropriate review and approval of clinical vendors and vendor contracts 
  • Support 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 assigned
  • Identify improvement projects within Clinical Operations and the broader Clinical Development team
  • Maintain project-level financial management, including budgeting, monthly forecasting and accruals and invoice reconciliation

Qualifications

  • BA/BS/MS and 10+ years directly related experience in clinical operations and contract management
  • In-depth knowledge and understanding of all aspects of clinical trial management, with a track record of successfully negotiating and managing CRO contracts, schedules and budgets
  • Proficient 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 trials
  • Microsoft Offices skill proficiency in (Word, Excel, PowerPoint, Outlook)
  • Proven track record of leadership and operational excellence required
  • Excellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment
  • Excellent 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.

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