Preclinical Program Coordinator

Oxford BioTherapeutics; San Jose (CA); Presencial; USD 65.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental and vision insurance

401(k) Plan

Paid Time Off

Annual bonus program

New hire stock options

Employee Referral Bonus Program

Descripción de la vacante

Oxford BioTherapeutics in San Jose, CA seeks a Preclinical Program Coordinator to support program offices and QA teams in delivering preclinical efforts. You will help maintain documentation, audits, and records, coordinating with scientists and managers to ensure traceability and timely actions.

Responsibilities include scheduling, minutes, tracking, and cross‑functional communication, with a focus on compliance and efficient program support.

Formación

• Bachelor’s degree in a scientific, life sciences, project coordination, business administration, or related discipline.
• 2+ years of experience supporting programs, projects, research operations, or administrative functions in biotech or pharma.

Responsabilidades

• Coordinate scheduling, agenda preparation, document collation, and minute-taking for preclinical program meetings.
• Capture minutes with decisions, risks, dependencies, and actions; assign owners and due dates.
• Maintain trackers for actions, milestones, documentation status, and audit readiness.
• Support cross-functional information flow among program managers, data management, and quality.
• Assist with audits, document control, and audit-trail maintenance to improve compliance.

Conocimientos

Program coordination

Documentation quality

Cross‑functional collaboration

Attention to detail

Communication skills

Audit readiness

Time management

Educación

Bachelor’s degree in a scientific or related discipline

Herramientas

SharePoint

Teams

Smartsheet

Asana

Electronic Lab Notebooks

WorkPlans

Descripción del empleo

About Oxford Biotherapeutics

Oxford BioTherapeutics (OBT) is a clinical‑stage biotechnology company developing antibody therapeutics for the treatment of cancer. You will play an integral role in the pre‑clinical development of novel immuno‑oncology therapeutics. Our OGAP® platform is the world's largest, cancer specific, membrane protein library, directly measuring plasma membrane protein expression in patient tumors. OGAP is used to identify novel, highly tumor specific antigens for novel first‑in‑class ADC, Bispecific T‑cell Engager (BITE®) and Chimeric Antigen Receptor (CAR) targets. Our lead asset, OBT076, is an Antibody Drug Conjugate (ADC) in Phase 1b clinical development. Our clinical and pre‑clinical pipeline of novel biologics is balanced between internal programs, focused on ADCs and checkpoint regulators, and externally partnered programs with key innovators in oncology such as Roche, GSK and BMS.

About Oxford Biotherapeutics

Oxford BioTherapeutics (OBT) is a clinical‑stage biotechnology company developing antibody therapeutics for the treatment of cancer. You will play an integral role in the pre‑clinical development of novel immuno‑oncology therapeutics. Our OGAP® platform is the world's largest, cancer specific, membrane protein library, directly measuring plasma membrane protein expression in patient tumors. OGAP is used to identify novel, highly tumor specific antigens for novel first‑in‑class ADC, Bispecific T‑cell Engager (BITE®) and Chimeric Antigen Receptor (CAR) targets. Our lead asset, OBT076, is an Antibody Drug Conjugate (ADC) in Phase 1b clinical development. Our clinical and pre‑clinical pipeline of novel biologics is balanced between internal programs, focused on ADCs and checkpoint regulators, and externally partnered programs with key innovators in oncology such as Roche, GSK and BMS.

Purpose of the Role

The Preclinical Program Coordinator will support the Program Office in the coordinated delivery of OBT’s preclinical programs by helping maintain high‑quality program documentation, compliance records, meeting outputs, workplan tracking, and audit preparation. This role is intended to provide structured operational and administrative support to Program Managers and scientific teams.

The role will help ensure that program‑related information is complete, well organised, traceable, and accessible to authorised stakeholders. Working closely with Program Managers, the Data Manager, Team Leads, and scientific contributors, the Preclinical Program Coordinator will support routine coordination activities, document control, action tracking, meeting preparation, and audit readiness across preclinical programs.

A key part of the role will be to support the Data Manager and Program Managers with auditing and quality checks of program‑related materials, WorkPlans, reports, meeting records, and associated documentation, helping ensure that internal procedures, study plans, collaborator requirements, and data management expectations are followed consistently.

Roles And Responsibilities

Program Office Coordination and Documentation Support

• Support the Program Office with day‑to‑day coordination of preclinical program activities, documentation, records, and follow‑up actions.
• Assist Program Managers in maintaining accurate and up‑to‑date program documentation
• Coordinate the collection, formatting, and filing of program‑related documentation to ensure records are complete, consistent, and stored in the appropriate program locations.
• Help maintain program‑specific SharePoint, Teams, or equivalent systems in line with internal data management and document control expectations.
• Support consistent use of document naming conventions, metadata, document status fields, and program identifiers across program records.
• Assist with coordination of information flow between Program Managers, scientific teams, Data Management, Operations, Quality, and other stakeholders.
• Support the creation and maintenance of program templates, trackers, checklists, and standardized ways of working to improve consistency across programs.
• Oversee our timesheet reporting system and ensure all colleagues have completed their timesheet within the allotted timeframe

Compliance, Audit, And Quality Support

• Support the Data Manager and Program Managers in planning, preparing, and documenting routine audits of program‑related WorkPlans, materials, reagents, and associated records.
• Assist with retrieval, organization, and preparation of audit data from relevant systems, including WorkPlan exports, material reports, audit forms, and supporting documentation.
• Help verify that program‑related records are complete, clearly documented, appropriately filed, and aligned with relevant internal procedures and program study plans.
• Support Data Management with program‑specific WorkPlan audits and Biological Materials and Reagents audits activities
• Support Program and Data Management with maintaining audit trackers, findings logs, action follow‑up records, and supporting documentation
• Help coordinate follow‑up on audit findings, including tracking responses, evidence of completion, and closure status.
• Support preparation of audit reports and audit closure documentation, ensuring appropriate sign‑off, filing, metadata, and completion status are maintained.
• Escalate documentation gaps, overdue actions, or potential compliance concerns to the relevant Program Manager, Data Manager, or Team Lead in a timely and constructive manner.
• Support implementation of process improvements arising from audits, lessons learned, and Program Office continuous improvement activities.
• Assist with maintaining awareness of relevant SOPs, policies, templates, and program‑specific requirements among team members, where appropriate.
• Assist with preparing metrics and information to Team Leads to drive compliance improvements within each department

Program Coordination Support

• Coordinate scheduling, agenda preparation, document collation, and minute‑taking for selected preclinical program meetings.
• Capture clear minutes, decisions, risks, dependencies, and action items from meetings, ensuring owners and due dates are recorded where appropriate.
• Support Program Managers in maintaining structured trackers for program actions, deliverables, milestones, documentation status, audit status, and follow‑up activities.
• Help monitor progress against defined program activities and highlight delays, missing information, or required follow‑up to the relevant Program Manager.
• Support coordination of internal scientific inputs required for program documentation, reports, reviews, and partner‑facing materials.
• Provide administrative and coordination support for vendor, CRO, or collaborator‑related documentation where needed, without acting as the primary owner of external relationships or contractual commitments.
• Help ensure that program records are inspection‑ready, easy to navigate, and appropriately maintained for future reference

Scope And Level Of Responsibility

• This role supports Program Managers and the Program Office but does not replace the responsibilities of a Program Manager.
• The role is not expected to own program strategy, budget management, portfolio prioritisation, contractual decision‑making, external alliance leadership, or final scientific/program decisions.
• The role is expected to provide reliable coordination, follow‑up, documentation, and audit support to enable Program Managers, Data Managers, and scientific teams to deliver programs efficiently and compliantly.

Please note the roles and responsibilities for the position include but are not limited to the above.

Desired Knowledge, Experience, And Skills

• Bachelor’s degree in a scientific, life sciences, project coordination, business administration, or related discipline; relevant experience may be considered in place of a degree.
• 2+ years of experience in supporting programs, projects, research operations, laboratory operations, or administrative functions within a biotechnology, pharmaceutical, life sciences, or related environment.
• Strong organisational skills, with the ability to maintain accurate records, track multiple actions, and coordinate information across several programs or workstreams.
• Excellent attention to detail and a strong commitment to documentation quality, data integrity, and consistent ways of working.
• Stong written and verbal communication skills with the ability to collaborate effectively across cross‑functional teams specifically with Program Managers, Data Managers, scientific staff, Team Leads, Operations, Quality, and external‑facing teams.
• Familiarity with preclinical research, drug discovery, antibody therapeutics, oncology programs, or laboratory workflows is desirable.
• Familiarity with WorkPlans, Electronic Lab Notebooks, SharePoint, Teams, Smartsheet, Asana, or similar project/document management systems is desirable.
• Working knowledge of SOPs, policies, audit trails, metadata, document status, version control, and controlled document environments is desirable.
• Ability to interpret procedures and templates and apply them consistently to routine documentation and audit support activities.
• Ability to follow up constructively with colleagues to obtain missing information, clarify actions, and support completion of documentation or audit activities.
• Comfortable working in a fast‑paced, cross‑functional environment where priorities may shift and multiple programs require support.
• Proactive, reliable, and able to escalat issues appropriately while remaining within the defined scope of the role.
• Support routine audits with meticulous record keeping and effective communication to drive improvements
• Working knowledge of quality management principles, including QMS, SOP lifecycle management, deviation management, and CAPA processes
• Experience supporting pre‑clinical and/or clinical‑stage programs
• Exposure to contract‑driven or partner‑specific quality and compliance requirements is highly desirable

One of our top priorities is to maintain the health and wellbeing of our employees and their families. To achieve this goal, we offer comprehensive benefits.

Benefits Offered

• Medical, dental and vision insurance
• The full premium amount for our employees and their dependents is covered by IGM
• FSA – Healthcare and dependent care (Flexible Spending Account)
• STD, LTD, Basic Life and AD&D Insurance, Supplemental Life and AD&D Insurance
• 401(k) Plan
• 120 hours of Paid Time Off
• 5 sick days per year
• 11 holidays
• Employee Referral Bonus Program
• Annual training budget for professional development
• Annual bonus program
• New hire stock options

Equal Opportunities Statement

OBT is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status, and veteran status. All qualified applicants will receive consideration for employment. One of our top priorities is to maintain the health and wellbeing of our employees and their families. To achieve this goal, we offer comprehensive benefits.