Careers
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 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. For more information, please visit our website at
www.drenbio.com.
Function:
Clinical Operations
Level:
Senior Administrator
Location:
San Carlos, CA (Remote candidates may be considered)
Reporting Manager:
Manager, Clinical Vendor Management
About the Opportunity:
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 from
study 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.
Role and Responsibilities:
Clinical Site Billing
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
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 for
potential clinical research sites
EDC/Travel Concierge Systems
Assist with EDC and travel systems across studies
Meeting Coordination and Planning
Help organize investigator meetings
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...
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