Bayan Shaheen Email & Phone Number

Foster City, Ca, Us

Menlo Park, California, Us

Boulder, Co, Us

- Working closely with Clinical Operations and Translational Medicine to coordinate and manage the sample collection (tissue/blood) for on-going and planned clinical trials that have TM/molecular diagnostic objectives in their design.- Created project plans with various testing vendors/biorepository to ensure protocolrequirements are met.- Interacted with investigators, study coordinators and study teams/CROs throughwritten and verbal communication to maintain effective management of biosamplespecimens being collected and submitted for clinical study.

Boulder, Co, Us

- Coordinated shipment of tissue blocks from biorepository /testing vendor back tothe sites, when requested, in a timely manner.- Coordinated shipment of biosamples from biorepository to testing vendors. Alsoensured the return of these samples to the biorepository, post-analysis, for long-termstorage.- Reconciled patient consent information with biosamples available to ensure properconsent from patients is available- Ensuring third party vendor deliverables are of high quality and in line with study timelines. - Designed and developed protocol-specific laboratory manuals, pathology charters,quick reference guides, and presentations to be utilized for training study site staff. - Trained site staff during SIV's on protocol specific sample collections, processing ofsamples, short- term storage conditions and shipment schedules.- Presented at domestic and international investigator meetings and managed the kitdisplay booth to ensure study coordinators become familiar with study specific kits.

Deerfield, Illinois, Us

- Provided general biosample management from sample submission logistics, coordinating shipment of samples to testing vendors (for research & clinical development purposes), managing the biorepository, and ensuring sample destruction where applicable.- Responsible for tracking laboratory samples and following up with sites/studyteam/CRO to resolve queries.- Issued queries in EDC and managed them to proper resolution.- Performed ongoing biosample reconciliations (using Excel formulas, vlookups...etc), as well as ad-hoc reconciliation requests to meet testing or regulatorysubmissions deadlines.

Sunnyvale, Ca, Us

- Providing assistance to Clinical Operations to ensure studies are completed, on time, within budget and in compliance with SOP’s, FDA regulations, and ICH/GCP guidelines.- Assisted in drafting feasibility questionnaire, protocol, informed consent form, andprotocol schedule-of -assessments.- Responsible for filing regulatory and clinical documents in Trial Master File- Tracking of confidential disclosure agreements, site status, and monitoring reports - Review and approval of regulatory documents prior to site activation and IP release- Interacted with sites and vendors as needed to respond to issues in a timely manner- Presented during international investigator meetings- Provided administrative assistance to the clinical team with planning InvestigatorMeetings, attending required meetings including study management team (SMT) meetings,as well as preparing agendas/minutes.

- Labeled membrane proteins from freshly resected, patient derived samples and tumor derived xenografts to expand existing database for new target identification.- Extensively characterized novel solid tumor targets and validated antibodies against them allowing projects to move along to in-vitro ADC killing assays and pre-clinical in-vivo studies. - Screened numerous endogenous, primary, and transfected cell lines for each target by multi-parameter FACS to determine surface expression, as well as intracellular markers by fix-perm techniques. - Performed lentivrial transduction to generate knockout lines to understand the biology of protein complexes and to help determine difference in sensitivity to ADCs.- Performed western blot analysis, ELISAs, and FACS to characterize potential variant isoforms of selected targets and tested the ability of in-house and commercial antibodies to discriminate against them.

- Worked in custom service operations department to help manufacture monoclonal antibodies. Handled numerous projects simultaneously while meeting strict deadlines.- Part of the hybridoma maintenance team and responsible for various tasks including hybridoma sub-cloning, maintenance, expansion, freezing, small and large-scale production of antibodies. - Worked with cross-functional teams to execute various immunoassays, including cell-based ELISAs, depending on project requirements.

- Developed and characterized a line of monoclonal antibodies specific for thirteen-lined ground squirrel white blood cells.- Stained ground squirrel tissue, with antibodies developed, to determine where leukocytes are retained in hibernating ground squirrels.- Monoclonal antibody specificity was determined by screening hybridoma supernatants using flow cytometery, immunohistochemistry, and immunoprecipitation.

• Studied immune responses, including immunoglobulin levels, to low-dose intradermal influenza vaccination • Developed in-house ELISA

La Crosse, Wi - Wisconsin, Us

Master Of Science, Biology- Microbiology Concentration

Bachelor Of Science, Biology- Biomedical Science