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 production. In 1994, we opened our custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies worldwide. In 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 production. In 2017, we passed a FDA inspection and were recommended to be approved for commercial drug substance manufacturing. In 2023, we added additional cGMP clinical production capacity in Milpitas, CA. In 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 inspection‑ready. What you’ll do A)Pre‑manufacturing orchestration (biopsy → sequencing → patient ID) Stand up thebiopsy tissue pipelinewith hospital partners; ownchain‑of‑identity & chain‑of‑custodyfrom tissue acquisition to sequencing and epitope selection; implement standard labeling (e.g., ISBT‑128 CoI) and sample tracking. Contract and manageCLIA‑certified sequencing labs(or in‑house partners) for tumor/normal WES/WGS, RNA‑seq, 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 e‑systems guidance in mind for EDC/eTMF/eConsent. B)Manufacturing interface Coordinate manufacturing windows, QC lot release documentation, andlabeling/packaging/shippingwith complete CoI. Maintain theIND‑quality CMC interfacewith the sponsor team; elevate deviations and drive CAPAs. C)Post‑manufacturing clinical execution Site activation(Montana + Bay Area partner centers like UCSF/Stanford or community partners): budgets/CTAs, IRB submissions, SIVs, training, pharmacy prep. Set up“experimental treatment center” operations: infusion/vaccination day flows, temperature excursions and excursion logs,investigational product accountability, emergency unblinding plans, DSMC/DMC coordination. Compounding operations:coordinate with site investigational pharmacies (or licensed outsourcing facilities) for aseptic prep perUSPandUSP(if hazardous components), and ensure California 503B license coverage when work occurs in‑state or across state lines. Patient monitoring:set visit schedules, ePRO collection, labs/imaging,AE/SAEprocessing, and PV reporting. Keep the eTMF inspection‑ready (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… 5–8+ yearsin clinical operations (oncology) with hands‑onsite activation → FPFV → monitoringand cross‑functional work with CMC/manufacturing.Early‑career, high‑trajectory operators welcome. Comfort working at theGCP/ICH E6andIND (21CFR312)interface; you’ve 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/first‑ops DNA: you’ve built scrappy systems, carried a pager, and can learn by osmosis first, then lead. Nice‑to‑haves Neoantigen/cancer‑vaccineexposure (biopsy→sequencing→HLA/epitope selection), immuno‑oncology trials. Compounding or investigational pharmacy coordination experience (USP/). Experience standing up treatment centers or early‑phase 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 Employee’s family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed) Basic life ($20,000 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 #J-18808-Ljbffr