Associate Director, IRT Systems

Company 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 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.

Tango's labs and offices are currently located at 201 Brookline Avenue, in the Fenway area of Boston.

Summary

Tango has an exciting new opportunity to join the Biometrics team as an Associate Director, IRT Systems. In this role you will reporting to the Vice President, Biometrics. You will be a subject matter expert at IRT-related integrations, forward thinking about the needs of a clinical development operations organization and possess high attention to detail. You will maintain a collaborative outlook, be a positive leader, with the ability to pursue multiple options in parallel.

Your Role:

• You will serve as the IRT system's Subject Matter Expert for Tango's clinical studies and programs
• Work collaboratively and cross-functionally to gather relevant requirements and utilize available resources to create the IRT system design, provide subject matter expertise, and ensure expert and on-time IRT system delivery and implementation
• Responsible for IRT vendor management, implementation project management, IRT requirements, and design including integrations with EDC and reporting systems, user acceptance testing, and maintenance
• Responsible for facilitation of IRT technical support, data changes; working with cross-functional stakeholders including Clinical Supplies, Clinical Operations, Biostatistics, and Clinical Data Management in order to achieve goals
• Responsible for UAT test case creation, oversee and facilitate signatures on documentation, and risk and impact assessment
• Responsible for the administration and uploading documentation to appropriate eTMF
• Deliver exceptional customer service and technical support to Clinical Operations, Biostatistics, Clinical Supplies, and Data Management
• Productively contribute or lead process updates, cross-functional initiatives, standards documentation updates, and/or SOPs
• May serve as business or product owner for internal applications that are IRT adjacent, such as forecasting, enrollment planning, and/or centralized clinical inventory and distribution systems
• Support inspection readiness activities as needed
• Additional duties and responsibilities as required

What You Bring:

• Five to eight years of clinical supply systems experience in the pharmaceutical or biotech industry
• Bachelor's degree in a science-based subject (advanced degree preferred)
• Prior demonstration of creative, capable problem solving and innovation as it relates to integrations between clinical systems (IRT, EDC, etc.) in a clinical research environment
• IRT Subject Matter Expertise
• Creative, capable problem-solver
• Experience in establishing and maintaining relationships with vendors
• Working knowledge of ICH, GAMP, FDA, IRB/IEC and other applicable regulations/guidelines and demonstrated understanding of clinical research protocol requirements
• Ability to work independently and act with initiative to address issues
• Excellent written and oral communication skills
• Demonstrated proficiency with MS Office, such as Outlook, Word, Excel, PowerPoint, and SharePoint

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.