Senior Clinical Operations Administrator

Senior Clinical Operations Administrator

About the Company:

Dren Bio is a privately held, clinical-stage biopharmaceutical company pioneering the discovery and development of first-in-class antibody therapeutics for the treatment ofcancer, 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 celltype 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 novelphagocytic 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 fromthe platform are specially designed to activate phagocytic mechanisms only in the presence of disease targets, potentially offering a superior safety profile compared to otherimmunomodulatory therapies. For more information, please visit our website

Clinical Operations

Senior Administrator

San Carlos, CA (Remote candidates may be considered)

Supports the Dren Bio Clinical Operations team by providing clinical operations assistance and documentation support for clinical studies. The position requires a highly motivated individual to work collaboratively in a cross-functional team environment. This individual will play a key role in ensuring excellence in a fast-paced, start-up environment.

Responsibilities will include support of Clinical Operations systems and processes fromstudy start-up through study closure in support of trial objectives, regulatory submissions,inspections and corporate goals. This position reports to the Manager, Clinical Vendor Management. This position can be remote based but will require periodic travel to our California headquarters.

• Clinical Site Billing
• Generate site activity statements for completed visits
• Create/update documents tracking all site payments
• Reconcile any errors in billing
• Contracts Management
• Manage contract flow and legal review process with sites
• Organize, reconcile, and maintain executed contracts
• Budget Negotiations
• Negotiate budgets with sites across all studies.
• Assist in building-out of budget grids for each study and respective amendments.
• Invoicing
• Review and approve site invoices
• Resolve invoicing issues
• Purchase Orders
• Generate and maintain site clinical purchase orders
• Assist with generating and maintaining vendor clinical purchase orders
• Site Cost Analysis
• Maintain site cost analysis trackers across all studies
• Site Startup Activities
• Assist with initial outreach, CDAs, and feasibility questionnaires forpotential clinical research sites
• Assist with EDC and travel systems across studies
• Meeting Coordination and Planning
• Organize other study related meetings (DSMB, Advisory Board, etc.)
• Assist with other departmental meetings
• TMF filing support
• Participate in weekly study team meetings
• Participate in occasional on-site meetings at Headquarters in California
• Work with other clinical team members as needed on various tasks

Bachelors degree, preferably in Life Sciences or Business

2+ years 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.

Demonstrated skill at effectively communicating department or area issues and results within and across functional areas and conducting presentations of technical information concerning…