Senior Specialist, Biosamples

Tango Therapeutics•Boston, MA

About The Position

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer. This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing. The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts Summary Tango Therapeutics has an exciting new opportunity for a Senior Specialist, Biosamples to join the Translational Clinical Science Team and support multiple clinical trials. This is a matrixed role relying on partnerships with internal stakeholders and external collaborators, biorepositories, laboratories, and contract research organizations (CROs). Working collaboratively across functions, you will ensure implementation, compliance, and support of clinical biosample plans and management for early phase and late-stage trials in Tango’s clinical portfolio. Your Role: Accountable for tracking, coordinating and overseeing all operational activities required to manage the lifecycle of clinical biosamples, ensuring sample integrity and GCP compliance throughout the process. Oversee shipment and receipt of clinical biosamples, document chain of custody throughout all stages of the clinical workflow, and respond to issues as needed to ensure biosample custody is protected. Manage relationships with laboratory and clinical study personnel internally and at external clinical sites, contract laboratories, and contract research organizations (CROs). Oversee compilation, quality control, and integration of cumulative inventory reports from external laboratories into Tango’s internal LIMS database. Conduct periodic audits of biosample inventory for each clinical program, and prepare audit summaries for relevant stakeholders. Independently collaborate with internal and external stakeholders to rapidly address biosample queries and facilitate data discrepancy resolution, as needed. Act as the subject matter expert in biosample collection kits, workflows, and instructions incorporated in the study laboratory manual and other site-facing clinical documents. Manage an internal biobank of non-clinical biosamples, including specimen acquisition, custody exchange with external collaborators, and maintenance of an accompanying LIMS Maintain effective verbal and written communication internally and with external collaborators and vendors. Ensure compliance and proper documentation in accordance with work instructions, SOPs, and all applicable regulations.

Requirements

Minimum of a Bachelor’s degree in a life science concentration
3+ years clinical research experience
Experience working with contract research organizations (CROs), central laboratories and third party clinical laboratories
Demonstrated familiarity with LIMS databases and other biosample tracking tools and systems
Solid understanding of good clinical practice (GCP/ICH) and good clinical laboratory practice (GCLP)
Strong communication, impeccable attention to detail, and outstanding follow-through
Ability to learn independently on the job in a face paced environment

Nice To Haves

Biotech or pharmaceutical sponsor experience highly preferred

Responsibilities

Accountable for tracking, coordinating and overseeing all operational activities required to manage the lifecycle of clinical biosamples, ensuring sample integrity and GCP compliance throughout the process.
Oversee shipment and receipt of clinical biosamples, document chain of custody throughout all stages of the clinical workflow, and respond to issues as needed to ensure biosample custody is protected.
Manage relationships with laboratory and clinical study personnel internally and at external clinical sites, contract laboratories, and contract research organizations (CROs).
Oversee compilation, quality control, and integration of cumulative inventory reports from external laboratories into Tango’s internal LIMS database.
Conduct periodic audits of biosample inventory for each clinical program, and prepare audit summaries for relevant stakeholders.
Independently collaborate with internal and external stakeholders to rapidly address biosample queries and facilitate data discrepancy resolution, as needed.
Act as the subject matter expert in biosample collection kits, workflows, and instructions incorporated in the study laboratory manual and other site-facing clinical documents.
Manage an internal biobank of non-clinical biosamples, including specimen acquisition, custody exchange with external collaborators, and maintenance of an accompanying LIMS
Maintain effective verbal and written communication internally and with external collaborators and vendors.
Ensure compliance and proper documentation in accordance with work instructions, SOPs, and all applicable regulations.