GOSSAMER BIO INC Biomarker Sample Operation Specialist, Translational Medicine Salary in the United States

Summary

As a Biomarker Sample Operation Specialist in our Translational Medicine team, you will be responsible for the oversight of clinical trial biomarker sample testing according to the schedule of events with clinical CRO and multiple bioassay vendors.  This position offers the rewarding opportunity to do work that directly impacts patients, and to work in an environment that fosters a culture of scientific investigation.

Responsibilities:

• Coordinate with translational Medicine Leader and deliver the Biosample strategy within multiple clinical programs in accordance with the requirements of quality, and ethical and regulatory standards, including ICH/ GDPR/GCP/GLP. You will Interface with data standards and data management teams to ensure biomarker data standards are defined for each readout in data transfer specification.
• Review clinical study protocols, informed consents, laboratory documents, case report forms, and service provider laboratory scope of work documents for sample handling details to ensure standardization and harmonization of Biosample activities across clinical trials and oversight of sample collection, processing, storage, and reconciliation; maximizing Biosample sample accrual and quality.
• Accountable for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of patient samples (oversight of sample collection at site, shipment to vendor for testing/processing, analysis and final sample disposition)
• Collaborate with study teams and the Translational Medicine Lead to develop Clinical Sample Management Plan
• Work closely with study teams to manage monitoring of appropriate patient consent for all biosample collection and testing.
• Responsible for documentation, SOPs and protocols related to clinical samples.
• Identifies stakeholders for questions impacting clinical samples and escalate issues to ensure a timely resolutions.
• Utilizes tracking systems in order to report progress, address issues and resolutions.
• Addresses questions from the CRO or clinical site on sample collections.
  
  

Requirements

• BS, MS or PhD Biochemistry, Biology, Medical Technology immunology, pharmacy or related pharmaceutical science
• 1-5 years of work experience in drug development, analytical development, or clinical trial project management.
• Some knowledge of clinical trials and understanding of the role of biomarkers in clinical studies
• Ability to manage and vet sample vendors and oversee sample management activities across multiple projects
• Ability to collaborate with a diverse group of scientists, clinicians, vendor labs, and a variety of internal and external team players to support product strategy
• Works effectively in a dynamic operational environment with cross functional stakeholders.
• Excellent written, organizational, and interpersonal communication skills necessary to interface with outside vendors, consultants, and internal team members
• Technical knowledge to maintain electronic files and experience with database entry.

Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state, and local laws governing nondiscrimination in employment.