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Senior Manager, Clinical Compliance

Boston, MA

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 located at 201 Brookline Avenue, in the vibrant Fenway area of Boston, Massachusetts. 

Summary

Tango has an exciting new role as a Senior Manager, Clinical Compliance. In this role you will support clinical program compliance and training and support clinical teams across the different stages of development in oncology. The successful candidate will be skilled at understanding and applying global compliance regulations and processes to trials as they advance through clinical development. You will collaborate with cross functional team members across the organization, vendors, and clinical sites. You will work to ensure the needs of the teams are addressed with a collaborative outlook and be solution-oriented to ensure standards, processes, and training are fit for purpose. You will report to the Director, Clinical Compliance.

Your Role:

  • Collaborate across R&D to ensure all trials are conducted in compliance with global regulations, ICH/GCP, and applicable business processes and practices
  • Review key study documents, team workflows, and trial outputs to ensure compliance, and provide guidance on remediation, training, and process improvement
  • Collaborate with stakeholders to manage compliance questions, and keep current with regulatory developments across the industry as well as evolving compliance best practices
  • Manage Quality Risk Management activities for assigned clinical trials
  • Collaborate with stakeholders to identify, mitigate, and remediate negative trends, risks, and quality issues across Clinical and Development Operations
  • Support and lead cross-functional teams to assess quality issues, and assist Clinical Quality with investigations, root-cause analysis, CAPA development and management, and effectiveness checks
  • Foster a culture of learning and continuous improvement
  • Collaborate with Clinical Quality to identify audit targets (clinical investigator sites, vendors, internal processes), and ensure associated issues are escalated and remediated
  • Conduct compliance site visits as necessary
  • Lead and provide support before, during, and after regulatory inspections
  • Establish, track, and report on KRIs/KQIs for R&D • Additional duties and responsibilities as required

What You Bring:

  • Bachelor’s degree in a life science or allied health field (e.g. nursing, medical or laboratory technology)
  • At least 5 years of experience in clinical research with direct clinical compliance oversight
  • Ability to build relationships with internal and external stakeholders
  • Ability to identify areas for process improvement and lead discussions to implement change
  • Excellent written and oral communication skills
  • Advanced working knowledge of GCP/ICH and other applicable regulations/guidelines
  • Good organizational skills for the management of clinical development compliance
  • Ability to work in a fast-paced environment
  • Proficiency with Microsoft Office and other related technologies

 

 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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