Associate Director, Clinical Operations

TRex Bio, Inc.; South San Francisco (CA); Hybrid; USD 150,000 - 180,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Short-term disability

Long-term disability

Life insurance

401(k) match

Bonus

Paid time off

Job summary

TRex Bio, Inc. is seeking an experienced Associate Director, Clinical Operations in South San Francisco, hybrid, with on-site presence 2-3 days per week. You will lead operational aspects of early- and late-stage immunology trials and partner with cross-functional teams to execute the clinical strategy.

The role reports to the Senior Director, Clinical Operations and requires strong project management, leadership, and communication to drive study execution, vendor oversight, and data integrity.

Qualifications

• BSc in natural or health sciences (biology, pharmacology, pharmaceutical sciences, or equivalent) preferred.
• 10+ years of clinical operations experience in early and late-stage trials.
• Strong knowledge of clinical trial processes and regulatory requirements; inspection readiness a plus.
• Excellent written and verbal communication, collaborative mindset, and problem-solving skills.

Responsibilities

• Oversee scope, quality, timelines, and budget for trials.
• Lead study execution teams to initiate and complete trials on time and within budget.
• Develop and review clinical and data management documents.
• Manage CRO relationships, site management, and quality metrics.
• Identify risks and implement mitigation strategies.

Skills

Project management

Leadership

Communication

Team collaboration

Problem solving

Education

BSc in natural or health sciences

Job description

Location: South San Francisco, CA – Hybrid, with the ability to be in office 2-3 days per week

As TRex Bio advances its first wholly owned asset into Phase 1 clinical trials, the company is seeking an experienced and dynamic Associate Director, Clinical Operations to lead and manage operational aspects of the company’s clinical trials.

Reporting directly to the Senior Director, Clinical Operations, the Associate Director will partner with the cross-functional team to execute on the clinical strategy of the company. The ideal candidate will bring strong expertise in early-phase clinical trials, a collaborative management style, and a passion for advancing innovative therapies.

Position Summary:

We are seeking a talented and highly motivated Associate Director, Clinical Operations to join our Clinical Development team. This position offers an opportunity to work as part of a small, dynamic team to bring novel immunomodulatory drugs to clinic.

A passion for teamwork, a can-do attitude, integrity and transparency are key attributes for this position. Come join our team!

Key Responsibilities include but are not limited to:

• Oversee scope, quality, timelines, and budget for early and/or late-stage clinical trial(s).
• Lead one or more study execution teams to ensure trials are initiated efficiently and completed on time, within budget and in compliance.
• Lead development and review of clinical and data management documents.
• Effectively communicate expectations to CROs, ensure appropriate site management and compliance with project plans, hold CROs accountable to timelines, and verify quality metrics.
• Anticipate obstacles or complex issues at the site, vendor, and study levels, and implement solutions.
• Build efficient and scalable study management and quality processes.
• Proactively identify issues for escalation, participate in problem-solving and implementation of risk mitigation.
• Ensure quality and integrity of the clinical data through management of data listings reviews.
• Drive and support development of work instructions and SOPs.
• Provide study-specific training and leadership to clinical research staff.

Required Qualifications:

• BSc in natural or health sciences (biology, pharmacology, pharmaceutical sciences, or equivalent) preferred.
• 10+ years of clinical operations experience with both early and late-stage immunology clinical trials preferred.
• Strong knowledge of clinical trial process, including working knowledge of all functional areas of clinical trials and regulatory requirements; prior inspection readiness experience preferred.
• Exceptional project management skills, organizational and problem-solving skills.
• Eager to learn with a collaborative, team-oriented mindset.
• Excellent written and verbal communication skills with an ability to express complex ideas to study personnel at research and clinical institutions.
• Diligent, highly motivated self-starter with a strong growth mindset and a positive “can-do” attitude towards assigned tasks

Compensation: $150,000.00 – $180,000.00, plus Discretionary Bonus

TRexBio offers a very competitivebenefitsincluding medical, dental, vision, short/long term disability, life insurance as well as 401(k) match, bonus and paid time leave.

TRexBio is a clinical stage biotechnology company leveraging cutting edge computational biology tools, a focus on human tissue, and expertise in immunobiology to develop revolutionary therapeutics for inflammatory diseases. Our powerful ‘deep biology’ discovery engine maps human tissue T reg behavior to disease processes, allowing us to identify and characterize novel targets for therapeutic intervention. Leveraging this platform, we are building a broad portfolio of novel therapies that modulate the immune system to restore human tissue immune homeostasis.

Our Culture:

At TRexBio,you will havethe opportunity to work with amazingly smart humans whostriveto make the world a better place. In addition to our team-centric culture, we believe that your individual creativitywill helpus to beourbest. Our staffhappy hours, organized byour Culture Club,bring us all together in creative and social activities. Our colleagues admire and respect one another. We celebrate our wins, update company news and acknowledge each other’s achievementweekly andmonthlyat all company meetingsthat celebrate our work and our people.

TRexBio is proud to be an AA/EEO employer and all qualified candidates will receive consideration without regard to characteristics protected by applicable local, state, or federal law, such as race, color, sex, age, religion, national origin, physical or mental disability, pregnancy, marital status, veteran or military status, genetic information, or sexual orientation.