Senior Manager, Biomarker Development

Tango Therapeutics•Boston, MA

5d•Hybrid

About The Position

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 Therapeutics has an exciting new opportunity for an experienced and innovative translational scientist in our Translational Medicine Team, to lead clinical biomarker development, in vitro diagnostic and companion diagnostic activities in support of ongoing clinical trials. This role will drive cross functional collaboration among discovery biologists, translational scientists, clinical operations, data management, regulatory, clinical compliance and quality groups to deliver biomarker insights to clinical development teams. Additionally, this position will administer operational aspects of clinical biomarker assays in clinical trials, including management of internal and external translational collaborations, third party laboratories and other clinical partners.

Requirements

Advanced degree in biological sciences or related, with at least 5 years relevant translational clinical experience in biopharma
Experience in oncology drug development
Track record of developing successful translational clinical assets in a biopharma setting
Demonstrated proficiency in clinical biomarker data generation, aggregation and analysis
Demonstrated facility in a GxP setting
Familiarity with domestic and/or international regulatory review and approval of IVD assays
Outstanding analytical skills, a highly organized approach and exceptional attention to detail
Proven track record as a collaborative team player, with superior communication style and well-developed interpersonal skills
Ability to thrive in an interdisciplinary setting across pre-clinical and clinical development arenas, and with colleagues at all levels

Responsibilities

Oversee design, development, validation, verification and implementation of translational and clinical-grade biomarker assays to inform essential clinical research questions.
Compile clinical biomarker assay data, conduct in-stream analyses, and package those translational insights for communication to key stakeholders throughout the clinical development organization.
Author and contribute content to biomarker plans and clinical study protocols.
Execute risk management of novel clinical biomarker assays, managing oversight and quality control of pre-analytic, analytic, and post-analytic assay components.
Perform technical assessments of existing and novel clinical biomarker assays and assay platforms for suitability, validity, clinical utility, robustness, and feasibility to meet business objectives.
Identify and vet translational and clinical biomarker assay vendors according to Tango’s GxP processes.
Manage relationships with third party vendors to ensure clinical biomarker assay outputs are delivered on-time, on-budget, and on-target to meet or exceed functional requirements and business objectives.
Install data transfer specifications with clinical biomarker assay laboratories, working in partnership with Tango’s clinical data management organization.
Contribute scientific expertise and biomarker data analysis in support of IVD regulatory submissions.
Contribute to optimization of translational medicine business process infrastructure.
Additional duties and responsibilities as required.