Head of Regulatory Operations - Boston, MA, United States - Tango Therapeutics

Description

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 Therapeutics has an exciting new role to join the team as our first Director, Pharmacovigilance Operations.

You will be responsible for working with clinical, cross-functional study teams, and third party vendors/CROs to manage and support drug safety and pharmacovigilance operational activities and deliverables across Tango's clinical development portfolio.

This role will report directly to the Head, Development Operations. You will serve as the primary pharmacovigilance lead on study teams and liaise with cross functional team members, as well as external vendors and services providers; performing drug safety study start-up, maintenance, and close-out activities
Participate in authoring, reviewing, and updating of clinical study documents such as: clinical protocols, informed consent forms, investigator brochures, clinical study reports, data management plans, reconciliation guidelines, and safety report forms
Manage the preparation, revision, and review of safety management plans
Responsible for pharmacovigilance vendor's day-to-day case intake, processing, and submission/exchange activities; ensuring high-quality reporting in the safety database and adherence to agreed processing timelines to support compliance in reporting submissions and exchange
Identify and escalate trends/issues in vendor performance based on routine oversight of vendor's activities, vendor-generated operational/compliance reports or metrics, and feedback from other functional stakeholders
Serve as a pharmacovigilance operations subject matter expert (SME) for inspections and audits, and support department/company inspection and audit readiness initiatives
Lead pharmacovigilance QA activities, including review and tracking of deviation reports, quality events, and corrective and preventative actions (CAPAs)
Ensure set-up and maintenance of pharmacovigilance document repositories and document sharing platforms; ensure timely document uploading, filing, and archival to support compliance and inspection readiness
Maintain the pharmacovigilance deliverables across the portfolio
Continued process improvement and system implementation related to drug safety signal detection and monitoring
At least 10 years relevant clinical drug safety/pharmacovigilance experience within the pharmaceutical or biotech industry, including 3+ years vendor oversight experience, required
Bachelor's Degree in a life-sciences; Drug safety database (Argus or ARISg) experience required
Direct experience with Health Authority inspections preferred
Expert knowledge of global regulatory pharmacovigilance requirements and guidelines (e.g., Solid understanding of pharmaceutical drug development process
Proficiency in Microsoft Word, PowerPoint, and Excel
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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