Associate Director, Clinical Operations

Alterome Therapeutics, Inc; San Diego (CA); On-site; USD 200,000 - 250,000; Full time

Job summary

Alterome Therapeutics, Inc. is seeking an experienced Clinical Trial Manager to provide trial operational oversight of CROs and vendors for studies within the U.S. and abroad.

You will ensure GCP/SOP and protocol compliance and build strong vendor/site relationships, advancing the KRAS program at the forefront of oncology research. This role requires collaboration across cross-functional teams in a matrixed environment, managing start-up, enrollment, monitoring, and data metrics with a high

Qualifications

• Ten years of clinical research experience with sponsor-side roles
• Direct site management (monitoring) and study management across trials
• Phase I oncology dose escalation experience
• Prior Clinical Trial Manager experience
• Prior CRA or Site Study Coordinator experience
• Strong knowledge of ICH GCP and global guidelines
• Judgment to operate independently across protocols and sites
• Ability to work in a matrixed, diverse environment
• High sense of urgency and accountability

Responsibilities

• Oversee trial progress, including drug safety and patient safety tracking and protocol deviations
• Drive site readiness, start-up, enrollment, monitoring activities, and data metrics from CROs and vendors
• Provide day-to-day vendor oversight (CRO, Biometrics, IXRS, PK/Central Lab, eTMF, Safety) for budget, timelines, and program objectives
• Perform periodic reviews of CRO eTMF/TMF for regulatory compliance
• Timely review of CRO monitoring reports and deliverables to ensure sponsor oversight
• Support study financial management, including review of site and vendor invoices
• Maintain direct relationships with clinical sites for high-quality trial execution
• Identify risks proactively and propose mitigation to cross-functional teams
• Share study knowledge and training to improve practices and procedures

Skills

Clinical trial management

Sponsor-side experience

Phase I oncology dose escalation

Independent judgment

Matrixed environment collaboration

GCP knowledge

Site monitoring

Vendor oversight

Risk identification & mitigation

Education

BA/BS in a scientific or healthcare field

Tools

ICH GCP guidelines

Job description

Reports to: VP, Clinical Operations

Location & travel: San Diego, CA (Hybrid) or remote with regular travel to HQ

About Alterome:

Alterome is a clinical-stage biotechnology company dedicated to transforming the lives of cancer patients worldwide, one alteration at a time. We advance best-in-class and first-in-class treatments where options were previously limited, pairing the expertise of our team with powerful technology to fuel innovation.

What sets us apart is our people and our culture of co-elevation: varied backgrounds, diverse expertise, one goal.

The role:

You will provide trial operational oversight of CROs and vendors for assigned studies, across U.S. and ex-U.S. regions. You will hold the line on GCP, SOP and protocol compliance, build strong vendor and site relationships and turn day-to-day execution into shared knowledge for the study team. Our lead program is in KRAS, and you will work at the front edge of it.

Compensation & benefits:

Base salary range: $200,000 to $250,000 annually . Actual base is determined by experience, skills, and internal equity.

What you will do:

• Oversee clinical trial progress, including drug safety, patient safety tracking, and protocol deviations, etc.
• Drive site readiness & start-up, subject enrollment, monitoring activities, and data metrics from CROs, central labs, and other vendors
• Provide day-to-day vendor oversight (CRO, Biometrics, IXRS, PK/Central Lab, eTMF, Safety) for adherence to budget, timelines, and program objectives
• Perform periodic reviews of the CRO eTMF/TMF to ensure compliance with applicable regulations and guidelines
• Timely review of CRO monitoring reports and associated deliverables, demonstrating sponsor oversight
• Support study financial management, including review of site and vendor invoices
• Maintain direct relationships with clinical sites to ensure high-quality, efficient execution of trial operations
• Identify risks proactively and bring mitigation recommendations to the cross-functional team
• Obtain and maintain in-depth understanding of the study protocol and related procedures to contribute strongly to study team knowledge by sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.

What you bring:

• BA/BS in a scientific or healthcare field, or an equivalent combination of education and experience
• Approximately 10 years of clinical research experience (at least 3-4 years recent experience on the sponsor-side) including direct site management (monitoring) and study management experience at a biopharmaceutical or pharmaceutical company, Phase 1 through Phase 3, both domestic and international
• Phase I oncology experience managing dose escalation
• Prior Clinical Trial Manager experience
• Prior CRA or Site Study Coordinator experience
• Deep working knowledge of ICH GCP and global, country, and regional clinical research guidelines as they apply to each phase of clinical study
• Judgment to operate independently across multiple protocols, sites, and therapeutic areas
• Interpersonal range to work in a matrixed, culturally diverse environment
• High sense of urgency