Senior Manager/Associate Director, Clinical Quality
4 weeks ago
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 to join the team as Senior Manager/Associate Director, Clinical Quality (GCP/GLP/GVP). Your primary responsibilities for this first in role position will be to ensure quality and compliance of Tango's development programs in accordance with applicable regulatory requirements (FDA/EMA, and current industry guidance) and internal procedures, as well as support the non-clinical team to ensure GLP studies are conducted in a compliant manner. In this role you will report to the Director, Quality & Compliance.
Your role:
* You will provide GCP/GLP/GVP QA oversight and support to cross functional stakeholders
* Support development of the annual GCP/GLP/GVP audit schedule
* Conduct and/or oversee GCP/GLP/GVP audits through closure as per the annual audit schedule, to include clinical investigator sites, CROs/vendors, process, system, study project, and document audits to assure compliance with global regulations, guidance, and internal procedures
* Track and effectively communicate deviation and audit trends to stakeholders
* Identify, investigate, escalate, track, and resolve quality issues originating internally and externally
* Liaise with QA counterpart at CRO/vendors
* Assist in preparing for and hosting regulatory inspections with cross functional stakeholders
* Conduct QA review of GCP protocols, ICFs, CSRs, and other clinical trial specific documents
* Conduct QA review of GLP reports and validation plans
* Additional duties and responsibilities as required
What you bring:
* Bachelor's Degree in a scientific discipline; advanced degree preferred
* 7-10 years in the pharmaceutical industry with 5 years in GCP QA
* Solid understanding of regulations and guidance for GCP, GLP, and GVP
* Experience with US and international clinical studies
* Able to travel domestically and internationally approximately 25% of the time
* Excellent verbal and written communication skills including experience reviewing clinical documents
* Good organizational skills and ability to work independently
* Collaborative problem-solver
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
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Boston, United States Tango Therapeutics Full timeCompany Overview 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...
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Boston, United States Tango Therapeutics Full timeCompany Overview 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...
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