SM/AD, Clinical Biomarker CDx Operations

Job Title: Senior Manager/Associate Director, Clinical Biomarkers & CDx Operations Location: San Diego Job Type: Full-Time Who We Are Avenzo Therapeutics, Inc. ("Avenzo" or "Company") is a clinical-stage biotechnology company focused on developing next-generation oncology therapies for patients. The Company was co-founded in 2022 by Drs. Athena Countouriotis and Mohammad Hirmand (former CEO and CMO of Turning Point Therapeutics, Inc., respectively). Our team is passionate about and committed to advancing a pipeline of potentially differentiated targeted oncology programs that make a difference in the lives of people with cancer. The Company is headquartered in San Diego, California. Position Summary Reporting to the Executive Director, Clinical Biomarkers & CDx, the Senior Manager/Associate Director, Clinical Biomarkers & CDx Operations will lead biospecimen operations across Avenzo clinical programs. This individual will oversee external vendors responsible for biospecimen collection, kitting, shipping, receipt, accessioning, storage, chain-of-custody, and sample analysis (e.g., central labs, specialty assay vendors, biorepositories, couriers, and kit providers). This role requires deep knowledge and experience in biomarker operations and clinical sample workflows to enable high-quality, analyzable biomarker data across clinical studies. Essential Job Functions And Responsibilities Manage clinical biomarker samples operations, including collection, processing, shipment, storage, analysis, data delivery, and final disposition; oversee interactions with CROs, central labs, diagnostic partners, biomarker vendors, biorepositories, couriers and kit providers, and drive issue escalation as needed. Own chain-of-custody, labeling standards, reconciliation, deviations, and CAPA processes for biospecimens, including systematic root-cause analysis and prevention. Enable robust data flow and traceability by coordinating vendor deliverables (e.g., manifests, accessioning logs, LIMS exports, assay result files) and ensuring timely, high-quality transfer to Avenzo systems/partners. Support the evaluation and selection of biomarker assays, diagnostic technologies, and external vendors to support drug development programs. Ensure compliance with regulatory requirements for diagnostic tests and precision medicine approaches used in clinical studies, including drafting Standard Operating Procedures (SOPs) to maintain high quality standards and reviewing information consent forms (ICFs) to ensure regulatory compliance. Guarantee inspection-ready operations consistent with applicable GxP/GCLP principles, internal procedures, and vendor quality agreements; support audits and inspections as needed. Prioritize effectively to deliver results within established timelines and budgets, partner with Finance/Procurement on contracting and invoice/PO processes as applicable. Preferred Qualifications Bachelor’s degree required, advanced medical or life sciences or a related area degree preferred (e.g., MS.) with 8+ years of experience in biomarker operations, clinical sample operations, central lab operations, clinical laboratory services, or biomarker operations. Strong working knowledge of clinical research operations and expectations for sample handling integrity, traceability, and documentation; experience supporting clinical trials preferred. Experience in global study start-up activities for clinical trials. Strong understanding of the drug development process and how diagnostic development can inform clinical strategy and commercialization is preferred. Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders. Strong analytical and problem-solving abilities, with a strategic mindset. This position requires periodic/regular travel, including up to 5 percentage of work time, which may include overnight travel. Physical Demands and Work Environment Physical Demands Constant or continuous use of a computer keyboard, monitor, and mouse to perform a variety of tasks. Constant or frequent sitting, standing, or walking. May lift and/or move objects of various weights. Work Environment On-site requirement (Monday through Thursday). Noise level in the work environment is usually moderate. Fast-paced, time sensitive environment with frequently changing priorities. Handle multiple projects simultaneously. Reasonable accommodations may be provided to enable qualified individuals with disabilities to perform the essential functions of the position. Salary Range The salary range for this position for a Senior Manager is $169,000 to $180,000 per year and for an Associate Director $180,000 to $188,000 per year. The final pay offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and years of experience within the job and the industry, education, and skills and certifications. Benefits Provided they meet all eligibility requirements under the applicable plan documents, employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life and AD&D insurance. Additional benefit programs include short-term and long-term disability insurance, flexible spending accounts, health savings accounts, and voluntary insurance programs, including voluntary life, AD&D accident, and critical illness. Employees will also be able to enroll in the Company’s 401(k) plan. In addition, employees will accrue 10 hours of paid vacation time every month and accrue 1 hour of paid sick leave for every 30 hours worked. Employees also enjoy 17 paid holidays each calendar year, including a winter closure, subject to applicable Company policies. All benefits are subject to the terms and conditions of the applicable plan documents and Company policies, which may be amended from time to time. Other Compensation The hired candidate will be eligible to receive an annual discretionary bonus and an equity award, subject to the terms of the applicable employment agreement, plan documents, and Company policies. Equal Employment Opportunity Avenzo is committed to providing equal employment opportunities to all employees and applicants without regard to an individual’s actual or perceived protected characteristic or characteristics, or any combination of protected characteristics including race (including traits associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, religious creed (including religious dress and grooming practices), color, sex (including childbirth, breastfeeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniformed service member and veteran status, marital status, pregnancy, age (40 and over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision-making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), the employee or their family member’s status as a victim of a qualifying act of violence, political activity or affiliation, use of cannabis off the job and away from the workplace, association with an individual who has, or is perceived to have, a protected characteristic or characteristics, or any combination of protected characteristics, or any other protected status in accordance with all applicable federal, state, and local laws. Notice to Search Firms/Third Party Agencies Avenzo does not accept unsolicited resumes from recruiters, employment agencies or search firms without a valid, executed search agreement in place. #J-18808-Ljbffr Avenzo Therapeutics