VP, Clinical Data Management & Standards

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.

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts.

Summary

Tango has an exciting new opportunity to join our growing Development Operations team as a VP, Clinical Data Management & Standards to work across programs. In this role position you will have a detailed knowledge of data management platforms and software clinical trial databases, and pharmaceutical drug development process including registration packages. You will be responsible for leading the data management team and providing direction and guidance to the clinical development team. You will be responsible for supporting end-to-end data management activities for multiple clinical studies as well as utilizing internal and external partners to standardize data naming, mapping, and visualization in accordance with industry standards (i.e., CDASH, SDTM, etc.).

Your Role:

• You will lead the Data Management team by providing expertise and guidance to the clinical development team regarding data standards, data quality, validation, and integration with regulatory requirements
• Oversee and provide clinical study level data management of outsourced clinical trials
• Author/review eCRFs, CCGs, and Data Management Plans
• Develop a Tango Data Standards Global Library focused on data alignment across the portfolio
• Consult with CRO and vendor partners to establish standardized electronic Case Report Forms (eCRFs)
• Collaborate with CRO partners and Tango Informatics to develop an automatized, streamlined process to deliver data, data metrics, and data outputs from multiple sources (e.g. EDC, Specialty Labs, IVRS, etc.) to the Tango Data Repository and/or clinical metrics tool
• Collaborate with CRO partners to utilize reporting functionality from EDC or vendor software, such as reporting functions from Medidata’s Rave, including use of Business Objects, J-Review, and SAS on Demand
• Own and drive standardized data delivery specifications and data import agreements, and ensure that they are aligned with data tools
• Provide, as needed, data tool training and user access alignment for all internal and external data platforms
• Work with cross functional teams to ensure streamlined and efficient data delivery
• Support data integration with clinical data visualization platform
• Additional duties and responsibilities as required

What You Bring:

• Bachelor’s Degree in computer science or a science-based subject; or Bachelor’s Degree outside of computer science or a science-based subject with a minimum of 12 years of clinical data management experience in biotech/pharma
• 10+ years of management experience in a clinical research environment, most of which should be in industry and preferably within oncology; including experience with EDC platforms
• Strong vendor management and oversight experience
• Strong technical skills across data platforms; programming experience preferred
• Experienced in designing clinical trials utilizing CDASH and SDTM standard terminology
• Cross Collaboration proficiency with other functions such as Biostatistics, Statistical Programming, and Pharmacovigilance
• Thorough command of FDA and ICH GCP guidelines to ensure the appropriate reporting of clinical trial data
• Experience with clinical data visualization software
• Experience in regulatory GCP inspections and audits

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.