Associate Director, Clinical Biomarkers

Poseida

Posted on: November 23, 2021

Closing: December 23, 2021

Salary: Undisclosed

Position Type: Full Time

Job Description

Poseida is seeking an outstanding Associate Director of Clinical biomarkers to join our clinical development team.

The successful candidate will work cross-functionally with partners in Translational Medicine, Clinical Biomarkers, Clinical Operations, Procurement, R&D, IT, Quality, Data Management and external vendors to support clinical biomarker operations and logistics to generate high quality biomarker data.

Responsibilities:

These may include but are not limited to:

  • Forging and managing strong relationships with multiple CRO biomarker testing labs and bioassay vendors. Biomarker specimen management and tracking, ensuring timely clinical sample testing and biomarker data management.
  • Key point of contact with external laboratories with oversight responsibilities for the development and finalization of agreements, statements of work, sample analyses, data transfer specifications and data transfer agreements.
  • Review and provide input into clinical study protocols, informed consents, and central laboratory documents to ensure quality and accuracy.
  • Ensure biomarker specimen handling and processing steps are appropriately described in the Clinical Lab Manuals for collection, processing, and shipping of patient samples. Ensures standardization and harmonization of end-to-end biospecimen activities across clinical trials, maximizing biomarker specimen accrual and quality.
  • Planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker specimens (oversight of sample collection at site, shipment to vendor for testing/processing, analysis, reconciliation, and final sample disposition).
  • Identifies stakeholders for questions impacting clinical samples and escalates issues to ensure a timely resolution.
  • Utilizes tracking systems such as LabVantage to report progress, address issues and resolutions in a timely manner.
  • Addresses questions from the CRO or the third-party vendors as it relates to sample collections and/or queries.
Requirements

Requirements, Knowledge, Skills and Abilities

  • MS or Bachelors degree or equivalent experience in a relevant scientific area with 8+ years’ experience in clinical, biomarker or translational aspects of drug development
  • The candidate will be highly motivated, innovative, and strong team player with excellent time management and organizational skills.
  • Training and/or experience in developing, implementing, and qualifying biomarker assays in Immunology, Immuno-oncology, Cancer biology and/or Hematology
  • Familiarity with assay and tests performed in cell and tumor biology, biochemistry, and molecular biology (genomics, transcriptomics, and proteomics) across diverse platforms is very desirable
  • Demonstrated ability to collaborate with a diverse group of scientists, clinicians, vendor labs, and a variety of internal and external team players to support product strategy.
  • Prior role in multidisciplinary projects and teams with ability to integrate cross-functional information is an advantage

Demonstrated ability for:

  • excellent interpersonal, verbal, and written communication skills
  • working successfully under pressure with tight timelines
  • working effectively in a dynamic operational environment with cross functional stakeholders
  • flexibility in a fast paced and highly changeable environment
  • creative thinking and proactive problem solving.

Poseida

Posted on: November 23, 2021

Closing: December 23, 2021

Salary($): Undisclosed

Position Type: Full Time

Similar Jobs


South San Francisco, United States

Senior Clinical Trial Manager

Pliant Therapeutics is a public, clinical stage biopharmaceutical compan...

Cambridge, United States

Director, Clinical Operations

Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focus...

Cambridge, United States

Director, Clinical Pharmacology

Fulcrum requires all employees to be fully vaccinated against COVID-19. ...

Redwood City, United States

Associate Director, Clinical Operations

Revolution Medicines is a clinical-stage precision oncology company focu...