Senior Clinical Operations Administrator

Dren Bio, Inc.; San Carlos (CA); Hybrid; USD 80,000 - 100,000; Full time

Benefits offered by this job

Equity incentive awards

Employer sponsored benefits

Total rewards program

Job summary

Dren Bio, Inc. in San Carlos, CA, seeks a Senior Clinical Operations Administrator to support the Clinical Operations team from study start-up through closure, including regulatory submissions and inspections. Join a fast-paced biotech startup focused on first‑in‑class antibodies.

The role involves documentation support, site billing, contracts, budgeting, and cross‑functional coordination. Remote candidates may be considered with periodic travel to California; reports to the Manager, Clinical

Qualifications

• Bachelor's degree in Life Sciences or Business.
• 2+ years experience in healthcare, specifically within Clinical Operations.
• Excellent verbal and written communication and organizational skills.

Responsibilities

• Support site billing and payments tracking and reconciliation.
• Manage contracts workflow and legal review with sites.
• Organize, reconcile, and maintain executed contracts and POs.
• Budget negotiations and building budget grids for studies.
• Review and approve site invoices; resolve invoicing issues.
• Assist with EDC and travel systems across studies.
• Coordinate TMF filing support and study meetings.
• Occasional on-site meetings at Headquarters in California.

Skills

Communication

Organization

MS Office proficient

Education

Bachelor's degree in Life Sciences or Business

Tools

MS Office

Job description

Senior Clinical Operations Administrator

About the Company:

Dren Bio is a privately held, clinical-stage biopharmaceutical company pioneering thediscovery and development of first-in-class antibody therapeutics for the treatment ofcancer, autoimmune disorders, and other serious diseases. Leveraging our wholly ownedtechnologies, we have built a robust R&D pipeline, including two clinical-stage candidatescurrently being evaluated across multiple ongoing clinical studies. Our lead clinicalcandidate, dibotatug, is designed to induce antibody-mediated killing of a specific celltype implicated in a range of oncology and autoimmune indications. In addition, we havelaunched multiple programs from our proprietary Targeted Myeloid Engager and PhagocytosisPlatform, a multispecific antibody-based technology engineered to selectively engage a novelphagocytic receptor expressed on myeloid cells (antigen presenting cells) for the targeteddepletion of pathologic cells and other disease-causing agents. Data generated using theplatform support its broad therapeutic potential, including initial programs focused ononcology, immunology, and neurology. Importantly, multispecific antibodies generated fromthe platform are specially designed to activate phagocytic mechanisms only in the presenceof disease targets, potentially offering a superior safety profile compared to otherimmunomodulatory therapies. For more information, please visit our website atwww.drenbio.com.

Function:

Clinical Operations

Level:

Senior Administrator

Location:

San Carlos, CA (Remote candidates may be considered)

About the Opportunity:

Supports the Dren Bio Clinical Operations team by providing clinical operations assistanceand documentation support for clinical studies. The position requires a highly motivatedindividual to work collaboratively in a cross-functional team environment. This individualwill 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 VendorManagement. This position can be remote based but will require periodic travel to ourCalifornia 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
• 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 respectiveamendments.
• 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

Education, Experience and QualificationRequirements:

Bachelors degree, preferably in Life Sciences or Business

2+ years experience in healthcare, specifically within Clinical Operations

Core Competencies, Knowledge and SkillRequirements:

Excellent verbal and written communication skills as well as interpersonal andorganizational 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 resultswithin and across functional areas and conducting presentations of technicalinformation concerning specific projects or timelines. Able to earn and fostercooperation with and of others.

Proven skill at effectively leading a cooperative team effort and organizingresources to achieve team goals. Able to make and prioritize process and resourcedecisions based on overall team needs.

Willingness and ability to travel as required.

Salaries, Benefits and Other Employee Perks:

Dren Bio strongly believes in investing in, and rewarding, its employees. This philosophy isembodied in the Company’s total rewards program, which includes competitive cashcompensation, equity incentive awards, and employer sponsored benefit offerings. The basepay range for this position at commencement of employment is expected to be between $80,000and $100,000 per year. At Dren Bio, pay ranges are determined by role, level(s), andlocation. The range displayed in this job posting reflects the minimum and maximum new hirepay for candidates located across all United States job markets. Within the range,individual pay will be determined by work location and additional factors, includingjob-related skills, experience, and relevant education or training. During the hiringprocess, Dren Bio’s Human Resources department can share more about the specific pay rangebased on the market location of the candidate.

Employment Practices:

Dren Bio is an equal opportunity employer. Employment decisions are based on merit andbusiness needs. Dren Bio will not discriminate against any job applicant because of race,color, national origin, ancestry, gender, sexual orientation, age, religion, creed, physicalor mental disability, gender identity, medical condition, pregnancy, marital status, veteranstatus, or any other characteristic protected by federal, state or local law.