Title: Manager, Biospecimen Management

Location: Menlo Park, CA

Forty Seven Inc. is committed to helping patients defeat their cancer. We are advancing immune-oncology through the engagement of new and complementary phagocytic pathways that enhance anti-tumor efficacy and selectivity..   

 

Summary:

The primary function of this role is to execute and oversee biospecimen management for clinical trials conducted by Forty Seven.  We are seeking a motivated, dynamic, team-oriented individual with a vision and passion for establishing and operating efficient biospecimen management activities.  This position will be part of the biospecimen management team and work closely with cross-functional teams in Clinical, Translational, Clinical Pharmacology, Biometrics, Data Management, and Clinical Operations and report into the Vice President of Development Operations. 

 

Position Responsibilities:

  • Ensure that biospecimen samples are managed, stored (includes long-term inventory of samples), and disposed of consistent with the clinical protocol, with the patient informed consent, and with regulatory and biohazard guidelines, and with international transport guidelines, if applicable.
  • Review of clinical protocols, subject informed consent forms, training documents, and other relevant study-related documents to ensure alignment and compliance with biospecimen management requirements
  • Ensure robust processes for maintaining chain of custody and compliance with GCP/GLP requirements for biospecimen collection
  • Develop study-specific biospecimen analysis plans (including specimen collection schedule and collection, handling, shipping and storage requirements) that align with the clinical protocol and stakeholder needs
  • Work with clinical study teams and central laboratory(ies) to develop study-specific guidelines and procedures for sample collection kit development, sample collection and handling, transport, storage, sample processing, testing, test result reporting, data aggregation, and sample destruction
  • Develop and present training guidelines and materials for clinical sites and internal study teams
  • Ensure effective and efficient processes for biospecimen management including sample tracking and data reconciliation and discrepancy resolution
  • Interact with central lab(s) responsible for biospecimen handling and storage (e.g., sample collection kit production, receiving, processing and storage)
  • Responsible for review of vendor invoices
  • Identify, communicate and problem solve relevant issues related to biospecimen management that present potential risk to study compliance, timelines or analyses
  •  Contribute to department process improvement by identifying areas for efficiency and improvement and developing/reviewing SOPs and processes as needed

 

Education/Experience/Skills

  • Bachelor's degree in science or health-related field required
  • 5+ years in Pharmaceutical or Biotech company, with at least 3 years in clinical biospecimen management and oversight for clinical trials
  • Prior experience in oncology and/or early phase, complex clinical trials preferred
  • Thorough and proven knowledge of applicable GCP, GLP, CFR and ICH guidelines
  • Ability and knowledge to work effectively with multiple stakeholders (clinical, translational research, clinical pharmacology and clinical operations)
  • Exceptional interpersonal skills, team-oriented approach, collaborative with ability to provide leadership and guidance to growing team/function

 

Knowledge Requirements:

  • Must have excellent written and verbal communication skills with ability to be diplomatic and professional in all situations
  • Strong interpersonal, project management and organizational skills; able to prioritize and work effectively in a fast paced environment
  • Working knowledge of MS Word, Excel and Adobe Acrobat; experience with LIMS and/or other lab management databases
  • Strong working knowledge of GCP/ICH regulations and guidelines as relates to biosample management

 

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