Biomaker Operations Manager - Redwood City, CA | Biospace
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Biomaker Operations Manager

AbbVie

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Location:
Redwood City, CA
Posted Date:
5/26/2017
Position Type:
Full time
Job Code:
1703327
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products — Imbruvica, Venclexta, and Empliciti — and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.

AbbVie is expanding its oncology hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) focused on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these three sites. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. This position is based at AbbVie in Redwood City, CA location.

POSITION DESCRIPTION:

We are searching for a Manager, Translational Medicine Operations. In this role, you will report directly to the Director, Translational Medicine in Clinical Development and will join an experienced team to implement biomarker strategies for Abbvie sponsored clinical trials. To be successful in this role, the ideal candidate will have experience in end to end biomarker operations and sample management.

KEY GOALS INCLUDE:


  • Effectively collect and manage biospecimens in Abbvie clinical studies in collaboration with Clinical Operations and Translational Medicine groups

  • Point of contact for all aspects of biomarker operations providing guidance and expertise on biospecimen management for exploratory and companion diagnostic strategies; member of biomarker subteams

  • Manage the collection of biomarker samples, including biopsy specimens, at clinical sites, tracking their distribution, reconciliation, analysis, storage, and disposition/destruction

  • Ensure protocols and biomarker collections are aligned with ICFs and CRFs and provide input on protocol/ICF development

  • Create biomarker sample training materials for clinical sites including lab manuals, reference guides, powerpoint slides to ensure the collection of high quality samples

  • Oversee biomarker sample collections at clinical sites, shipment and transfer at CRO/academic institutions

  • Manage budgets, timelines, sample inventories

  • Pro-actively identify and implement best practices for biomarker sample management
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Requirements

BASIC QUALIFICATIONS:



  • Bachelor’s or Master’s degree in life sciences or medical/healthcare related field and 3+ years industry experience in clinical trials and biomarker operations

  • Knowledge of clinicaloperations and biospecimen management, preferable in Oncology


PREFERRED QUALIFICATIONS:



  • In depth understanding of biomarker sample operations, best practices and standardization, with an ability to apply basic scientific expertise for quality sample collections

  • Basic knowledge of sample processing and bioanalytical techniques (blood and biopsy samples)

  • Demonstrated ability to manage multiple projects and priorities and complex sample logistics in multiple clinical studies

  • Clinical development experience interacting with teams conducting clinical trials

  • Experience working with sample repository databases, vendor databases, IVR/EDC systems to track, manage, and reconcile biospecimens

  • Understanding of regulatory and compliance ICH/GCP aspects of biospecimen collections, use and storage in an industry setting

  • Effectively work in a cross-functional team environment, interacting with various levels within the organization as well as vendors/academic sites

  • Organization, orientation to details, and effective time management

  • Excellent written and oral presentation skills in the English language