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Biomarker Operation Manager Jobs (NOW HIRING)

Dyne Therapeutics

Director, Imaging Biomarkers

Waltham, MA · On-site

$272K/yr

Manage imaging biomarker operations in clinical studies including protocol development, support site training, and data quality assurance * Foster a culture of innovation and scientific rigor ...

Integrated Resources INC

Biomarker Scientist

New Haven, CT · On-site

$35.50 - $44.50/hr

... operational support. Including providing logistical support for samples and compounds management ... Years of Experience 0-3. * Primary Responsibilities: * Assist Lead Biomarker Scientist to develop ...

Artech Information System LLC

Biomarker Scientist

Groton, CT · On-site

$35 - $44/hr

Perform general flow cytometry operation, including sample preparation and analysis. Experience in ... Perform data entry using laboratory information management system (LIMS) Write experimental SOPs

Integrated Resources INC

Biomarker Scientist

New Haven, CT

$35.50 - $44.50/hr

Perform general flow cytometry operation, including sample preparation and analysis. Perform qu ... Perform data entry using laboratory information management system (LIMS) Write experimental SOPs.

Syneoshealth

OR · On-site

Clinical Project Manager II - Biomarker Study Management Experience required (Sponsor Dedicated ... Serve as the operational point of contact for all biomarker-related processes * Work closely with ...

PSG Global Solutions

Biomarker Scientist

New Haven, CT

$35.50 - $44.50/hr

Perform general flow cytometry operation, including sample preparation and analysis. * Experience ... Perform data entry using laboratory information management system (LIMS) * Write experimental SOPs.

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Biomarker Operation Manager information

What are the key skills and qualifications needed to thrive as a Biomarker Operation Manager, and why are they important?

To excel as a Biomarker Operation Manager, you need a solid background in biomedical sciences or a related field, experience in clinical trials, and a deep understanding of biomarker development and validation. Familiarity with laboratory information management systems (LIMS), regulatory compliance tools, and project management software is typically required. Exceptional organizational, communication, and leadership skills are crucial for coordinating cross-functional teams and managing complex projects. These competencies ensure the timely, compliant, and efficient delivery of biomarker strategies that are critical to successful clinical research and drug development.

What is the difference between Biomarker Operation Manager vs Biomarker Scientist?

AspectBiomarker Operation ManagerBiomarker Scientist
Primary RoleOversees biomarker assay operations, manages teams, ensures quality controlConducts biomarker research, develops assays, analyzes data
Required CredentialsBachelor's or Master's in life sciences, project management experienceAdvanced degree (PhD or Master's), laboratory expertise
Work EnvironmentClinical labs, research organizations, biotech companiesResearch labs, academic institutions, pharmaceutical companies
Industry UsageCommon in clinical trial settings and biotech firmsPrimarily in research and development roles

The Biomarker Operation Manager focuses on managing biomarker assay operations and team coordination, ensuring quality and compliance. In contrast, the Biomarker Scientist is dedicated to conducting research, developing new assays, and analyzing data. Both roles require scientific credentials, but their daily responsibilities and work environments differ significantly.

What are some common challenges faced by a Biomarker Operation Manager when coordinating multi-site clinical trials?

A Biomarker Operation Manager often encounters challenges such as ensuring consistent sample collection and processing across multiple sites, maintaining strict compliance with regulatory standards, and facilitating effective communication between cross-functional teams. Managing logistics for timely shipment and storage of biological specimens, as well as addressing unforeseen protocol deviations, are also key difficulties. Successfully navigating these challenges requires strong organizational skills, attention to detail, and proactive problem-solving to support seamless trial execution.

What does a Biomarker Operation Manager do?

A Biomarker Operation Manager oversees the planning, execution, and management of biomarker studies within clinical trials. They coordinate with cross-functional teams to ensure the proper selection, collection, analysis, and reporting of biomarker data. Their role is crucial in ensuring compliance with regulatory requirements, timelines, and scientific objectives. Biomarker Operation Managers also work closely with external vendors and laboratories to ensure high-quality and timely data delivery, supporting the overall drug development process.
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Biomarker Operation Manager jobs near you
Senior Manager, Biomarker Development

Senior Manager, Biomarker Development

Tango Therapeutics

Boston, MA • Hybrid

Other

Posted 27 days ago

Job 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.

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts

Summary

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.

Your Role

  • 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

What You Bring

  • 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

This is a hybrid/flexible role!

#LI-Hybrid

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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