Clinical Trial Manager / Senior Manager

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. Significantly backed by the industry’s top investors, the company is developing next-generation, multi-payload ADCs that feature differentiated payload and linker technologies to maximize therapeutic benefit by enabling targeted delivery of multi agents to tumor cells. 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. 

KEY 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. 

QUALIFICATIONS  

• 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. 
  • 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. 
  • 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. 

• Leadership experience (mentoring CTAs/CRAs or managing teams) preferred for AD level. 

WHAT CALLIO THERAPEUTICS OFFERS 

• 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 further enquiries, please email us at [email protected]. 

For more information, please visit www.calliotx.com and our LinkedIn page.