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Callio Therapeutics · 1 month ago

Clinical Trial Manager / Senior Manager

Seattle, WA

Full-time

Onsite

Senior Level, Lead/Staff

5+ years exp

Callio Therapeutics is a biotech company focused on developing innovative multi-payload antibody-drug conjugates to improve cancer patient outcomes. The Clinical Trial Manager will lead the planning and execution of clinical programs, ensuring quality and compliance while managing global oncology studies.

BiotechnologyHealth CareMedical

Responsibilities

Oversee end-to-end clinical trial operations, including CRO and vendor management, study start-up, site activation, monitoring oversight, and study close-out

Lead day-to-day study management to ensure studies are executed on time, within budget, and in accordance with GCP, ICH guidelines, and applicable regulatory requirements

Serve as the primary operational point of contact for internal cross-functional teams (Clinical Development, Regulatory, CMC, Biometrics, Safety, QA) and external partners

Support the development, review, and maintenance of key study documents, including protocols and IB

Drive the development, review, and maintenance of key study documents, including informed consent forms, study manuals, and operational plans

Manage and oversee study budgets, timelines, and vendor performance, identifying and mitigating risks proactively

Ensure inspection readiness and support regulatory submissions as needed

Contribute to the design and implementation of clinical operational processes and best practices suitable for a growing biotech organization

For AD level: Provide mentorship and leadership to junior team members (CTAs, CRAs), fostering professional growth and a culture of accountability

Qualification

Clinical trial managementOncology experienceCRO managementBudget managementRegulatory complianceLeadership experienceProblem-solving skillsAdaptability

Required

Bachelor of Science or other degree in life sciences discipline preferred

5-10+ years of progressive experience in clinical operations, including direct global trial management; prior biotech or small-company experience strongly preferred

Proven track record managing global FIH dose escalation trials with experience in oncology and/or novel modalities (e.g., ADCs, biologics) highly desirable

Strong knowledge of clinical trial processes from start-up through close-out

Demonstrated ability to manage CROs, vendors, and study budgets, with excellent problem-solving skills

Hands-on, proactive, and adaptable in a fast-paced, resource-limited startup environment