
Senior Manager, R&D 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.
The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts
Summary:
Reporting to the VP, Information Technology, the Senior Manager, R&D Systems will plan, implement, manage, administer, and support core business application software for Tango’s various R&D Departments (Clinical, Quality, Regulatory, CMC, BioStats, Pharmacovigilance, etc.). In addition, you will be responsible for qualification and validation activities for all of the systems that require GxP compliance.
Your Role:
- Maintain the current Information Architecture and implement accompanying infrastructure to support the digital strategy
- Oversee master data management systems and tools, supporting broader data governance efforts to drive data quality
- Manage, plan, and maintain significant budget cycles for technology projects, as well as ongoing licenses and support/maintenance contracts for the R&D application portfolio
- Collaborate with IT management and liaisons in the planning and implementation of corporate production applications, systems, and core infrastructure
- Monitor, maintain, administer, and support enterprise application software to meet or exceed service level agreements
- Create and maintain documentation for application configurations, services, network mapping, processes, security, and compliance configurations
- Participate and help develop, implement, and maintain policies, procedures, and associated training plans for the administration and usage of GxP solutions
- Participate and assist in the planning of corporate disaster recovery exercises and drills
- Oversee installation, configuration, maintenance, and troubleshooting of application software, infrastructure, and peripheral devices
- Provide for the support and troubleshooting of corporate enterprise applications and systems as required
- Configure and deploy application software and systems to ensure smooth and reliable operation to fulfill business objectives and processes
- Monitor systems performance and troubleshoot problem areas as required
- Provide technical support, primarily for GxP-validated computer systems
- Ensure systems are validated in accordance with regulatory requirements, such as 21 CFR Part 11
- Provide Regulatory Defense for GxP systems to external regulatory authorities
- Maintain good working relationships with selected business units and vendors
- Provide IT-specific guidance to departments for outsourcing needs
- Assume IT lead for installation, validation, troubleshooting, and management of hardware and software for all GxP systems
- Responsible for application user and group administration
- Additional duties and responsibilities as required
What You Bring:
- Bachelor’s degree with 8-10 years of relevant work experience supporting R&D systems, preferably in a biotech/pharma organization. Equivalent work experience will be considered
- Experience with Microsoft Office 365, R&D Systems, and enterprise document management systems (Egnyte, Veeva, etc.)
- Understanding of the basics of GDPR for systems holding European patient data
- Demonstrated experience in solution design and enterprise architecture, with focus on scalability and automation
- Knowledge of server class hardware and network infrastructure best practices
- Ability to manage projects simultaneously, manage conflicting priorities, and be flexible when priorities change
- Ability to manage, mentor, and direct the personal development of staff
- Demonstration of excellent leadership and communication skills
- Demonstration of strong organizational skills, including the ability to prioritize
- Experience working in a pharma/biotech environment on FDA/GxP-validated systems, including 21 CFR Part 11 and applicable regulations, guidance, and compliance requirements related to computerized systems
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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