Senior Manager, Biomarker Development
Tango Therapeutics
5 hours ago
Remote friendly (Boston, MA)
United States
Clinical Research and Development
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 translational insights for communication to key stakeholders.
- 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.
- Identify and vet translational and clinical biomarker assay vendors according to GxP processes.
- Manage relationships with third party vendors to ensure outputs are delivered on-time, on-budget, and on-target.
- Install data transfer specifications with clinical biomarker assay laboratories, working with clinical data management.
- Contribute scientific expertise and biomarker data analysis in support of IVD regulatory submissions.
- Contribute to optimization of translational medicine business process infrastructure.
Qualifications / What You Bring:
- Advanced degree in biological sciences or related; at least 5 years relevant translational clinical experience in biopharma.
- Experience in oncology drug development.
- Track record of developing successful translational clinical assets in biopharma.
- 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, strong organization, and exceptional attention to detail.
- Proven collaborative team player with strong communication and interpersonal skills.
- Ability to thrive in an interdisciplinary setting across pre-clinical and clinical development.
- 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 translational insights for communication to key stakeholders.
- 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.
- Identify and vet translational and clinical biomarker assay vendors according to GxP processes.
- Manage relationships with third party vendors to ensure outputs are delivered on-time, on-budget, and on-target.
- Install data transfer specifications with clinical biomarker assay laboratories, working with clinical data management.
- Contribute scientific expertise and biomarker data analysis in support of IVD regulatory submissions.
- Contribute to optimization of translational medicine business process infrastructure.
Qualifications / What You Bring:
- Advanced degree in biological sciences or related; at least 5 years relevant translational clinical experience in biopharma.
- Experience in oncology drug development.
- Track record of developing successful translational clinical assets in biopharma.
- 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, strong organization, and exceptional attention to detail.
- Proven collaborative team player with strong communication and interpersonal skills.
- Ability to thrive in an interdisciplinary setting across pre-clinical and clinical development.