Clinical Operations Lead — Longevity & Oncology

Yowei Therapeutics; Milpitas (CA); On-site; USD 140,000 - 185,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k with company match

PTO 10 days

Job summary

Yowei Therapeutics is seeking a hands-on Clinical Operations Manager to lead planning and execution of longevity and oncology clinical programs. You will translate clinical strategy into practical operating plans, manage study start-up, oversee sites, vendors, timelines, and budgets, and ensure compliant, timely execution from feasibility to closeout.

The role reports to the Chief Medical Officer and requires on-site work with travel to sites and partners.

Qualifications

• 5+ years of progressive clinical operations experience in biotechnology, pharmaceuticals, CRO, or academic setting.
• 2+ years of experience leading clinical studies, sites, vendors, projects, or personnel.
• 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 timelines, budgets, contracts, CROs or vendors, risks, and cross-functional dependencies.
• Strong written communication, meeting leadership, documentation, prioritization, and practical problem‑solving skills.

Responsibilities

• Lead clinical operations across longevity and oncology studies from feasibility to closeout.
• Translate protocols into operating plans, timelines, site workflows, staffing plans, and readiness criteria.
• Lead site identification, feasibility, qualification, selection, budgeting, contract coordination, initiation, activation, ongoing management, and closeout.
• Coordinate investigators, clinical sites, CROs, labs, pharmacies, imaging, couriers, and other partners.
• Own study start-up and activation tracking, essential documents, regulatory submissions, contracts, budgets, training, and access.
• Develop and manage clinical operations budgets, forecasts, and vendor scopes.
• Establish enrollment, visit, monitoring, data, and milestone tracking for each study.
• Oversee participant recruitment readiness, site performance, enrollment progress, and data-cleaning support.
• Plan and oversee monitoring activities with internal staff or CROs, including reports and escalation.
• Ensure Trial Master File and site files are complete and inspection-ready with QA/Regulatory teams.
• Identify and elevate risks, maintain decision logs, and deliver concise status updates to leadership.
• Create SOPs, work instructions, templates, training, metrics, and vendor oversight practices.

Skills

Strong communication

Meeting leadership

Documentation

Prioritization

Problem solving

Education

Bachelor’s degree in life sciences, nursing, pharmacy, public health, clinical research, or related field

Job description

Yowei Therapeutics is seeking a hands-on Clinical Operations Manager to lead planning and execution of longevity and oncology clinical programs. You will translate clinical strategy into practical operating plans, manage study start-up, oversee sites, vendors, timelines, and budgets, and ensure compliant, timely execution from feasibility to closeout.

The role reports to the Chief Medical Officer and requires on-site work with travel to sites and partners.