Associate Director, Clinical Operations

Alterome Therapeutics, Inc•San Diego, CA

2d•$200,000 - $250,000•Hybrid

About The Position

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.

Requirements

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

Responsibilities

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.