Clinical Trial Manager​/Senior Manager

Overview

ABOUT CALLIO THERAPEUTICS

Headquartered in Seattle and Singapore, Callio Therapeutics is focused on realizing the promise of multi-payload antibody-drug conjugates (ADCs) to transform cancer patient outcomes. Callio Therapeutics is focused on driving its HER2-targeted dual-payload ADC to the clinic, gathering key clinical data, and progressing its pipeline assets.

ABOUT THE ROLE

Callio Therapeutics is seeking an experienced and highly motivated Clinical Trial Manager (CTM) / Sr. CTM / Associate Director, Clinical Operations to lead the planning and execution of our clinical programs. This individual will play a critical role in managing global, early-phase oncology studies and ensuring the highest standards of quality, compliance, and operational excellence.

The successful candidate will thrive in a fast-paced, collaborative biotech environment and be comfortable working both strategically and hands-on to advance Callio’s innovative pipeline.

• 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

• Education:
  
  Bachelor of Science or other degree in life sciences discipline preferred
• Experience:
  
  5-10+ years of progressive experience in clinical operations, including direct global trial management; prior biotech or small-company experience strongly preferred
• Experience:
  
  Proven track record managing global FIH dose escalation trials with experience in oncology and/or novel modalities (e.g., ADCs, biologics) highly desirable
• Skills:
  
  Strong knowledge of clinical trial processes from start-up through close-out
• Skills:
  
  Demonstrated ability to manage CROs, vendors, and study budgets, with excellent problem-solving skills
• Skills:
  
  Hands-on, proactive, and adaptable in a fast-paced, resource-limited startup environment
• Leadership:
  Leadership experience (mentoring CTAs/CRAs or managing teams) preferred for AD level

• Competitive compensation and comprehensive benefits package
• Opportunity to work in a dynamic, innovative, and collaborative environment
• Significantly contribute to potentially groundbreaking therapies for cancer patients

For enquiries, please email

For more information, please visit  and our Linked In page.