Director of Clinical Operations

CSBio is a peptide contract manufacturing founded in 1993. Our initial products were a complete line of automated synthesizers for manufacturing and process development with a focus on cGMP 1994 we opened our custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies 2004 we opened our peptide production facility in Menlo Park CA and in 2014 we expanded our production capability through the addition of a new state of the art building dedicated to cGMP peptide 2017 we passed a FDA inspection and were recommended to be approved for commercial drug substance 2023 we added additional cGMP clinical production capacity in Milpitas 2025 we are expanding to Montana as a result of SB535.

We need a driven operator toown the steps immediately before manufacturing(biopsy sequencing HLA/neoantigen selection patient ID) andafter manufacturing(site readiness patient monitoring experimental treatment center setup pharmacy/compounding coordination and concierge services) while keeping the program inspectionready.

What youll do

A)Premanufacturing orchestration (biopsy sequencing patient ID)

• Stand up thebiopsy tissue pipelinewith hospital partners; ownchainofidentity & chainofcustodyfrom tissue acquisition to sequencing and epitope selection; implement standard labeling (e.g. ISBT128 CoI) and sample tracking.
• Contract and manageCLIAcertified sequencing labs(or inhouse partners) for tumor/normal WES/WGS RNAseq and HLA typing; enforce SLAs and QCs.
• Drive theneoantigen calling workflowwith bioinformatics (variant calling HLA binding prediction ranking) and handoff to manufacturing slotting.
• Ensureproper consent/eConsentlanguage covering tumor sequencing data use and recontact; keepPart11and FDA esystems guidance in mind for EDC/eTMF/eConsent.

B)Manufacturing interface

• Coordinate manufacturing windows QC lot release documentation andlabeling/packaging/shippingwith complete CoI.
• Maintain theINDquality CMC interfacewith the sponsor team; escalate deviations and drive CAPAs.

C)Postmanufacturing clinical execution

• Site activation(Montana Bay Area partner centers like UCSF/Stanford or community partners): budgets/CTAs IRB submissions SIVs training pharmacy prep.
• Set upexperimental treatment center operations: infusion/vaccination day flows temperature excursions and excursion logsinvestigational product accountability emergency unblinding plans DSMC/DMC coordination.
• Compounding operations:coordinate with site investigational pharmacies (or licensed outsourcing facilities) for aseptic prep perUSP<797>andUSP<800>(if hazardous components) and ensure California 503B license coverage when work occurs instate or across state lines.
• Patient monitoring:set visit schedules ePRO collection labs/imagingAE/SAEprocessing and PV reporting. Keep the eTMF inspectionready (Part11).
• Concierge patient services(travel/lodging/navigation) designed toavoid AKSpitfalls; any recruitment ads or landing pages go throughIRB reviewbefore use.

D)Program build & reporting

• Build the first ops pod (reg/IRB coordinator CRC patient navigator) and vendor roster (EDC/eConsent/eTMF).
• Weeklydashboards: TATs enrollment deviations product flow safety signals risk register.

You might be a fit if

• 58 yearsin clinical operations (oncology) with handsonsite activation FPFV monitoringand crossfunctional work with CMC/manufacturing.Earlycareer hightrajectory operators welcome.
• Comfort working at theGCP/ICH E6andIND (21CFR312)interface; youve touched IRBs HIPAA/PHI and sponsor/CRO/vendor management.
• Have shipped samples throughCLIA/CAPlabs and wrestled withCoI/CoCtraceability.
• Know your way aroundPart11systems (eConsent/EDC/eTMF).
• Founder/firstops DNA: youve built scrappy systems carried a pager and can learn by osmosis first then lead.

Nicetohaves

• Neoantigen/cancervaccineexposure (biopsysequencingHLA/epitope selection) immunooncology trials.
• Compounding or investigational pharmacy coordination experience (USP<797>/<800>).
• Experience standing up treatment centers or earlyphase units (UCSF/Stanford/Sutter/Kaiser or similar).

• Medical dental and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 85% for Employee and 50% for Employees family; Dental: Aetna Dental Delta Dental Guardian Dental MetLife Dental. Vision: VSP and Aetna EyeMed)
• Basic life ($20000 paid by company) and supplemental life insurance (optional supplemental).
• Disability insurance 50% standard employer paid.
• 401k 10% 1:1 match
• PTO policy. 10 days PTO
• Companywide paid holiday during: Week of July 4 Thanksgiving (2 days) Week of December 25
• Carpool clean air vehicle and cell phone reimbursement
• Employee rewards and recognition program
• Company organized social events
• Quarterly sponsored team building activities

Required Experience:

Director