Manager, Biospecimen Lead- Cell Therapy & Early Oncology

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• Manager, Biospecimen Lead - Cell Therapy & Early Oncology

  Department Name/Functional Area

  Biospecimen & Imaging Management - HOCT

  Location

  US

  Job Description

  Position Summary

  Support the strategic and tactical planning as well as operational management of biospecimens, which contribute to asset development. Our functional teams ensure the timely availability of high-quality, accurate biological specimens and manage biospecimen information driven by end-to-end visibility and best-in-class logistics.

  Duties/Responsibilities

  • Oversee and manage the complete lifecycle of biospecimens collected for clinical studies with minimal supervision.
  • Serve as a Core Clinical Team member responsible for shipping/sample movement and management, including requests, query and inventory reports, follow-up on active issues with vendors, preparation of sample management related reports, and review/preparation of tracking activities (such as vendor manifests/inventories, tissue/blood match pairing, depleted/non-viable samples, and loading documents to Shared Drive folders).
  • Independently review clinical study protocols, providing comparisons of vendor statements of work and biospecimen-relevant sections with feedback as needed.
  • Perform routine vendor management responsibilities and request/access necessary vendor/system inventory files for specimen tracking.
  • Create biospecimen trackers using various tracking tools (MS Excel, Spotfire, Tableau, or Polaris) with support.
  • Identify biospecimen-related risks with support from the risk library, and assist in developing mitigation strategies. Support the Critical to Quality (C2Q) process with guidance if needed.
  • Exercise judgment within policy and procedure boundaries, troubleshoot routine problems, and understand when to ask for guidance. May need assistance to prioritize BOW activities during critical deadlines.
  • Maintain intermediate working knowledge of compound and study-related biospecimen requirements.

  Reporting Relationship

  Reports to the Director in Biospecimen Management – Cell Therapy & Early Oncology

  Qualifications

  Specific Knowledge, Skills, Abilities:

  • Minimum of 3-4 years of academic, biotech, healthcare, or pharmaceutical industry experience or equivalent.
  • Basic understanding of clinical and biomedical research, GCP, GLP, CLIA, data management, risk management, and regulatory issues.
  • Demonstrated clinical trial experience in healthcare/medical/laboratory settings or equivalent.
  • Preferred vendor experience (e.g., Central Labs, Bioanalytical, Biomarker, CROs, Biospecimen Storage Vendors).
  • Ability to develop skills for stakeholder management, including conflict and change management.
  • Preferred but not mandatory biospecimen management experience.
  • Developing knowledge of the drug discovery or developmental process.
  • Ability to apply scientific and/or functional knowledge to conduct studies in assigned areas.
  • Effective communication skills, including the ability to create and deliver presentations/information/data to knowledgeable audiences with limited supervision.
  • Ability to adopt a biopharma enterprise-wide and entrepreneurial mindset, act with a sense of urgency, accountability, and integrity, and enjoy the process.
  • Demonstrates change agility and willingness to pivot current ways of working to new models.

  Education/Experience/Licenses/Certifications:

  • Scientific degree (Associates, Bachelors, Masters, or higher) or project management or equivalent experience.

  Travel: