Celgene Specialist II Biospecimen Operations in Seattle, Washington

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

POSITION Specialist II, Biospecimen OperationsSUPERVISOR Sr. Manager/Associate Director, Biospecimen OperationsDEPARTMENT Biospecimen Operations

PREREQUISITES

Bachelors Degree in a life sciences or healthcare related field with 6+ years relatedprofessional experience in an academic clinical research setting,clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environmentORMasters Degree in a life sciences or healthcare related field and 5+ years relatedprofessional experience in an academic clinical research setting,clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment

Summary/Scope

The Specialist II is expected to execute on Biospecimen Operations (BSO) service deliverables under minimalsupervision in a fast-moving team-based environment. The incumbent will provide biospecimen and clinicaltrial support across multiple, often complex, studies in oncology and inflammation/immunology. He/She isexpected to serve as the lead trainer on biospecimen logistics and represent BSO at national/internationalclinical site initiations and investigator meetings. The Specialist II is viewed as a mentor to peers and isexpected to assist them with issue analysis and solutions. The ideal candidate is a team-player who is detail oriented;is able to successfully multi-task, supporting several projects simultaneously; understands thebroader context of support that he/she provides; and knows how to identify/recognize and resolve issues withminimal supervision.

Responsibilities will include, but are not limited to, the following:

The Specialist II will be expected to drive internal and external work group results to support the department’smission. In doing so, the incumbent is expected to stay current on the broader context of support that he/sheprovides, assess quality support from the process improvement perspective, identify gaps and needs, propose anddrive solutions, He/She will also be expected to escalate/resolve issues, lead/facilitate effective meetings andmanage conflict with minimal guidance. The primary responsibilities of the BSO Specialist II are to support TDand clinical teams in the implementation and maintenance of biospecimen management strategies for oftencomplex, global clinical studies in each of the following areas under minimal supervision:

  1. BSO: Maintain knowledge/status of assigned clinical protocols and be able to follow good clinicalpractices (GCP), standard operating procedures (SOPs) and working procedures (WPs). Might becalled upon to assist in the authorship of SOPs and WPs. Be able to handle, identify and resolvecomplex biospecimen-related/site issues and implement viable solutions in a timely manner. Play akey role in planning and designing clinical trial and biospecimen operations support internally andexternally.

  2. Biospecimen management: Utilize software tools such as Labmatrix to track biospecimens, identifydiscrepancies, verify and document consent, and ensure compliant utilization of biospecimens byfollowing written procedures. Maintain regular metrics of biospecimen activities for studies thathe/she supports. Follow up and resolve discrepancies through communication with study team, sites,or CROs/vendors within specified time frames.

  3. Clinical study teams: Plan/design biospecimen handling logistics and review biomarker-relatedclinical documents clinical protocols, ICFs, CRFs for successful study start-up. Create and maintainbiospecimen laboratory manuals and provide hands-on biospecimen processing training at clinicalsites. Support clinical and/or CRO to review supporting biospecimen documentation, labels,requisition forms and manifests to ensure documented biospecimen chain-of-custody and the rapidreconciliation of biospecimens.

  4. CROs and Vendors: Work with manager and clinical development teams to plan/design biospecimenhandling logistics with preferred vendors on the manufacture of sample collection kits and executionof associated logistics; will be expected to take on a primary role in working with scientists andanalytical laboratories on generating work order requests, work specifications and logistics.

Skills/Knowledge Required:

The incumbent should have proficient skills in each of the following areas and have demonstrated application inthe context of clinical trials and biospecimen management.

 Clinical Trials: Proficient knowledge of FDA regulatory requirements and GCP; have a demonstrated,intuitive understanding of clinical trials. Scientific/Laboratory Skills: Proficient knowledge of relevant therapeutic and technical areas;demonstrated understanding of laboratory techniques in the life sciences; demonstrated understanding ofprinciples in clinical research and clinical procedures involving blood/biopsy collection, handling andprocessing. Biobanking: Understanding of global biobanking issues; proficient experience working in organizationsadhering to quality standards and working with regulations pertaining to general biospecimentransportation requirements. Drug Development: Proficient understanding of the drug development process. Professional inter-personal skills and excellent oral/written communication. Experienced in presentinglogistics and processing instructions, including basic scientific and clinical content, to internal andexternal audiences. Basic leadership skills in conflict management, facilitation and negotiation. Proficient computer skills in Microsoft Office. Experience with databases and intermediate-level Excel a plus.

 Up to 20% travel to clinical sites to train sites on biospecimen procedures.

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Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE

At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”

There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.