Clinical Operations Manager

Yowei Therapeutics and Yowei Oncology are stealth-stage life-sciences companies working closely with CSBio to advance peptide-based clinical programs. Their work spans longevity and peptide therapeutics, clinical trials, evaluation of a 503A pharmacy model, personalized synthetic neoantigen peptide oncology programs, and supporting microbiology and laboratory capabilities. Together, they are building the clinical, pharmacy, data, laboratory, and operational infrastructure needed to responsibly translate peptide programs into patient-facing studies and services. Both companies expect to remain in stealth through Q1 2027. CSBio is a peptide contract manufacturing founded in 1993. CSBio initial products were a complete line of automated synthesizers for manufacturing and process development, with a focus on cGMP production. In 1994, CSBio opened a custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies worldwide. In 2004, CSBio opened a peptide production facility in Menlo Park, CA and in 2014, CSBio expanded production capability through the addition of a new, state of the art building dedicated to cGMP peptide production. In 2017, CSBio passed a FDA inspection and were recommended to be approved for commercial drug substance manufacturing. In 2023, additional cGMP clinical production capacity was added in Milpitas, CA. Yowei Therapeutics and Yowei Oncology are seeking a hands-on Clinical Operations Manager to lead the planning and execution of longevity and oncology clinical programs. Reporting to the Chief Medical Officer, this person will translate clinical strategy and protocols into practical operating plans, lead study and site start-up, coordinate sites and vendors, manage timelines and budgets, and ensure consistent execution from feasibility through closeout. The Manager will support the build while preserving the medical, safety, regulatory, and investigator authority of qualified owners. Job Duties: Lead clinical operations across longevity and oncology studies from feasibility and planning through study start-up, enrollment, conduct, closeout, and archival. Translate protocols into detailed operating plans, study timelines, responsibility matrices, site workflows, visit requirements, staffing plans, vendor plans, and readiness criteria. Lead site identification, feasibility, qualification, selection, budget and contract coordination, initiation, activation, ongoing management, and closeout. Coordinate investigators, clinical sites, CROs, central and specialty laboratories, pharmacies, imaging providers, couriers, technology vendors, and other study partners. Own study start-up and site-activation tracking, including essential documents, regulatory and ethics submissions, contracts, budgets, training, supplies, systems access, delegation, and activation dependencies. Develop and manage clinical operations budgets, forecasts, purchase requests, vendor scopes, invoices, and change orders within approved company controls. Establish enrollment, visit, monitoring, data, specimen, investigational-product, issue, risk, and milestone tracking appropriate to each study. Oversee participant-recruitment readiness, site performance, enrollment progress, protocol adherence, data-cleaning support, query resolution, and corrective action follow-through. Plan and oversee monitoring activities using internal personnel or CROs, including monitoring plans, visit reports, findings, escalation, and closure of action items. Ensure the Trial Master File and site files are complete, current, controlled, and inspection ready in coordination with Regulatory, Quality, and study-site personnel. Identify and elevate operational, safety, medical, regulatory, quality, supply, and timeline risks to the appropriate qualified owner; maintain clear decision and action logs. Lead cross-functional study meetings and provide concise status reporting to the CMO and leadership on milestones, enrollment, budget, risks, decisions, and recovery plans. Create and maintain fit-for-purpose clinical operations SOPs, work instructions, templates, training, metrics, and vendor oversight practices with Quality and Regulatory review as applicable. Hire, train, supervise, and develop clinical operations personnel, including clinical research coordinators and study-management staff; establish clear responsibilities and backup coverage. Support audits, inspections, due diligence, and sponsor or partner reviews by providing complete operational records and timely responses. Bachelor’s degree in life sciences, nursing, pharmacy, public health, clinical research, or a related field; equivalent relevant experience may be considered. 5+ years of progressive clinical operations experience in biotechnology, pharmaceuticals, a CRO, an academic research center, or a clinical-site organization. 2+ years of experience leading clinical studies, sites, vendors, projects, or clinical operations personnel. Demonstrated experience with study start-up, site initiation and activation, study conduct, monitoring oversight, enrollment, vendor coordination, and closeout. Working knowledge of ICH-GCP, informed-consent requirements, protocol compliance, essential documents, safety escalation, privacy, and inspection readiness. Experience managing clinical timelines, budgets, contracts, CROs or vendors, risks, and cross-functional dependencies. Strong written communication, meeting leadership, documentation, prioritization, and practical problem-solving skills. Ability to work on site as required and travel to clinical sites, investigators, and vendors. 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