SMAD, Clinical Biomarker CDx Operations
Job Location:
San Diego, CA - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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
- Bachelors 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 $169000 to $180000 per year and for an Associate Director $180000 to $188000 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 Companys 401(k) 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.
The information above is intended to provide a general description of benefits and other compensation and is not a substitute for applicable plan documents or company policies.
Applications for this position are anticipated to close on July 31 2026. For more information about this posting please contact.
Equal Employment Opportunity
Avenzo is committed to providing equal employment opportunities to all employees and applicants without regard to an individuals 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 breast feeding 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 members 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.
