Senior Clinical Operations Administrator

About the role

Dren Bio is a privately held, clinical-stage biopharmaceutical company pioneering the discovery and development of first-in-class antibody therapeutics for the treatment of cancer, autoimmune disorders, and other serious diseases. Leveraging our wholly owned technologies, we have built a robust R&D pipeline, including two clinical-stage candidates currently being evaluated across multiple ongoing clinical studies. Our lead clinical candidate, dibotatug, is designed to induce antibody-mediated killing of a specific cell type implicated in a range of oncology and autoimmune indications. In addition, we have launched multiple programs from our proprietary Targeted Myeloid Engager and Phagocytosis Platform, a multispecific antibody-based technology engineered to selectively engage a novel phagocytic receptor expressed on myeloid cells (antigen presenting cells) for the targeted depletion of pathologic cells and other disease-causing agents. Data generated using the platform support its broad therapeutic potential, including initial programs focused on oncology, immunology, and neurology. Importantly, multispecific antibodies generated from the platform are specially designed to activate phagocytic mechanisms only in the presence of disease targets, potentially offering a superior safety profile compared to other immunomodulatory therapies.

Responsibilities

• Generate site activity statements for completed visits
• Create/update documents tracking all site payments
• Reconcile any errors in billing
• Maintain master files over site budgets
• Manage contract flow and legal review process with sites
• Organize, reconcile, and maintain executed contracts
• Negotiate budgets with sites across all studies
• Aid in building-out of budget grids for each study and respective amendments
• Review and approve site invoices
• Resolve invoicing issues
• Generate and maintain site clinical purchase orders
• Assist with generating and maintaining vendor clinical purchase orders
• Maintain site cost analysis trackers across all studies
• Assist with initial outreach, CDAs, and feasibility questionnaires for potential clinical research sites
• Assist with EDC and travel systems across studies
• Help organize investigator meetings
• Organize other study related meetings (DSMB, Advisory Board, etc.)
• Assist with other departmental meetings
• Support TMF filing
• Participate in weekly study team meetings
• Occasionally participate in on-site meetings at Headquarters in California
• Work with other clinical team members as needed on various tasks

Qualifications

• Bachelor's degree, preferably in Life Sciences or Business
• 2+ years of experience in healthcare, specifically within Clinical Operations
• Excellent verbal and written communication skills as well as interpersonal and organizational skills
• Proficiency in MS Office applications
• Self-sufficient and able to work with minimal oversight
• Proven skill at effectively leading a cooperative team effort and organizing resources to achieve team goals
• Willingness and ability to travel as required