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 to own the steps immediately before manufacturing (biopsy → sequencing → HLA/neoantigen selection → patient ID) and after 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 the biopsy tissue pipeline with hospital partners; own chain‑of‑identity & chain‑of‑custody from tissue acquisition to sequencing and epitope selection; implement standard labeling (e.g., ISBT‑128 CoI) and sample tracking.  
• Contract and manage CLIA‑certified sequencing labs (or in‑house partners) for tumor/normal WES/WGS, RNA‑seq, and HLA typing; enforce SLAs and QCs.  
• Drive the neoantigen calling workflow with bioinformatics (variant calling → HLA binding prediction → ranking) and handoff to manufacturing slotting.  
• Ensure proper consent/eConsent language covering tumor sequencing, data use, and recontact; keep Part 11 and FDA e‑systems guidance in mind for EDC/eTMF/eConsent.  

B) Manufacturing interface

• Coordinate manufacturing windows, QC lot release documentation, and labeling/packaging/shipping with complete CoI.
• Maintain the IND‑quality CMC interface with the sponsor team; escalate 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 per USP <797> and USP <800> (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/SAE processing, and PV reporting. Keep the eTMF inspection‑ready (Part 11).  
• Concierge patient services (travel/lodging/navigation) designed to avoid AKS pitfalls; any recruitment ads or landing pages go through IRB review before use.  

D) Program build & reporting

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

You might be a fit if…

• 5–8+ years in clinical operations (oncology) with hands‑on site activation → FPFV → monitoring and cross‑functional work with CMC/manufacturing. Early‑career, high‑trajectory operators welcome.
• Comfort working at the GCP/ICH E6 and IND (21 CFR 312) interface; you’ve touched IRBs, HIPAA/PHI, and sponsor/CRO/vendor management.  
• Have shipped samples through CLIA/CAP labs and wrestled with CoI/CoC traceability.  
• Know your way around Part 11 systems (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‑vaccine exposure (biopsy→sequencing→HLA/epitope selection), immuno‑oncology trials.  
• Compounding or investigational pharmacy coordination experience (USP <797>/<800>).  
• 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