Clinical Biosample Associate / Sr. Associate

Position Summary:

Biomea Fusion is hiring a Clinical Biosample Associate / Sr Associate who will enable biomarker research by supporting the lifecycle of clinical samples. The Clinical Biosample Associate / Sr. Associate will liaise with various internal and external functional groups including Translational, Clinical Science, Clinical Operations, and external vendors including clinical central laboratories and specialized third-party laboratories. Reporting to the Clinical Biosample Sr. Manager, this position will work closely with the Clinical Science team and vendors to ensure that clinical samples are collected, shipped, and accounted for in a transparent manner, and delivered to stakeholders for translational projects. The candidate will support the development portfolio assisting in the development and delivery of biosample strategies across multiple programs in accordance with regulatory and ethical guidelines. This role is accountable for sample project management including logistics, handling, inventory, and dispensation. Manage long-term archival of samples with respect to regulatory strategic, and/or biochemical limitations.

This role is on site 3 days a week in Redwood City, California.

Essential Responsibilities:

• Work with functional groups to understand protocol sample requirements and identify vendors and providers capable of performing such activities.
• Participate in the identification, selection, set-up and oversight of laboratory vendors.
• Be the point of contact for sample management for bioanalytical labs including PK, ADA, Dx, and PD.
• Work with the functional groups that are responsible for planning, organization, and oversight of the entire lifecycle of clinical samples. Closely collaborate with translational, clinical sciences, clinical operations, and other involved clinical developmental groups.
• Support all study biosample operational activities, including sample reconciliation, sample metrics, and reporting, data delivery and cleaning process, and final sample disposition.
• Evaluate the cross-programs performance of lab vendors and be responsible for cross-portfolio alignment.
• Provide data to support high-level forecasting of sample size, timelines, scenario planning, and feasibilities and any estimation of budget, turn-around time or additional resources required.
• Establish, implement, and maintain processes for sample management.
• Participate in protocol and IB reviewing and clinical trial start-up activities, provide inputs on data management plans, iDMB, UAT and ICF reviews as it relates to clinical sample collections and management.
• Participate in strategy for a scalable sample storage, tracking, and access.
• Ensures study adherence to ICH/GCP/GLP, data management, regulatory, legal, and quality assurance issues/processes, and SOPs.
• Represent Translational Medicine and Clinical Science on clinical study management teams and serve as subject matter expert for sample operations and technical aspects of sample collection, storage and shipping.
• Manage kit building and central laboratory CROs to develop work orders, kit specifications and Lab Manuals as necessary to enable sample collection.
• Proactively identify and resolve and/or escalate study-related issues.
• Responsible for sample management, storage, and/or destruction per requirements.
• Analyze clinical sample inventories to identify missing samples.
• Publish updates to communicate sample collection performance metrics to team. Open and track queries to resolve issues with samples.
• Balance multiple priorities in a fast-paced, team-based environment and work independently when needed.
  
  
  

Education and Experience Requirements:

• Master’s degree or bachelor’s degree with 2+ years project management, sample management, or clinical operations experience, clinical lab experience.
• Expertise in MS Office applications, especially in using Excel to analyze and visualize data.
• Experience working with laboratory CRO vendors or working with pharma sponsors
• Excellent oral and written communication skills in English.
• Organizational skills, attention to detail, and effective time management with ability to adapt to changing priorities, excellent analytical and interpersonal skills.
• 1+ years direct clinical/biomarker operation experience, with exposure spanning initiation through study completion preferred.
• Scientific background or proven enthusiasm working on scientific initiatives, especially in oncology or translational science preferred.
• Ability to work with minimal supervision.
• Experience extracting and analyzing data from clinical databases, vendor data portals, LIMS, or in-house databases preferred.
• Highly proficient using Microsoft Office Suites. Knowledge of MS Teams is a plus.
• Collaborative, team-oriented mindset with strong verbal and written communication skills.
• Pre-clinical or clinical research bench work in the laboratory is a plus.
• Self-motivated, detail-oriented leader with exceptional organizational, leadership and interpersonal skills.
  
  
  

Industry:

• Biotechnology
  
  
  

Employment Type:

• Full-time
  
  
  

Equal Employment Opportunity:

At Biomea Fusion, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

Compensation:

The expected salary range for this role is $105,000 - $135,000. An individual’s position within the range is influenced by multiple factors, including skills and experience in role, overall performance, individual impact and contributions, tenure, and market dynamics. Base salary is one part of the overall total rewards program, which includes competitive cash compensation, including discretionary bonus program, equity awards and comprehensive benefits program.