Lauren Zahra

Senior Manager, Oncology Clinical Science

BeiGene

Dec 2023 - Jul 2025 (1 year 8 months)

Facilitate the generation of, update, and/or review key documents, including, but not limited to: • Protocol concepts, synopses, protocols, and amendments • Informed Consent documents; Investigator Brochures; clinical study reports • Abstracts, posters and manuscripts • Clinical sections of INDs (and equivalent applications), NDAs (and equivalent applications), Developmental Safety Update Reports, Health Authority briefing documents, Orphan Drug applications, and annual reports • Risks / benefits analysis for applicable documents • Partner with Clinical Operations and other functional areas for the successful implementation and execution of clinical studies • Support Clinical Operations in clinical trial budget planning and management • Con

Senior Oncology Clinical Scientist

Arcus Biosciences

Aug 2022 - Aug 2023 (1 year 1 month)

Partner with cross-functional teams with potential oversight from senior team members to conduct clinical studies, including operational feasibility, data management deliverables, preparation of meeting materials, communication plans, safety and medical monitoring, preparation of status update reports, and study close-out activities. Support senior team members with medical monitoring reports, safety reviews, site interactions, and reviewing TFLs. May be responsible for analytical support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations. Analyze information to assess issues relating to protocol conduct and/or individual subject sa

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Senior Lead Oncology Clinical Scientist

IO Biotech

Jan 2022 - Oct 2022 (10 months)

Leads medical and safety monitoring, and subsequent data cleaning, among cross functional study teams (proficient in utilization and programming within relevant applications to include J Review, SAS, EDC (RAVE) specific reports, Power BI) • High level technical medical writing - primary authorship of key complex clinical trial documents (protocols, plans and manuals, regulatory submissions, ICFs, narratives, CSR, etc.) • Clinical and scientific reviewer (presentations, documentation, SOPs, etc.) • Presents complex scientific, clinical and protocol specific information in forums such as SIVs, Investigator Meetings, investor congress(es), international symposia and conferences. • MSL role in terms of KOL, investigator, site staff and medical

Associate Director, Clinical Scientist

AstraZeneca

Jun 2021 - Dec 2021 (7 months)

Program Level: • Assists with the clinical input to the clinical development plan at all stages of the program. • Supports the science-to-man sub team (TSST) to integrate the biology, translational and clinical science into the program strategy • Supports in developing recommendation(s) on further development strategies to internal committees • Supports the preparation of clinical and other data for governance and other presentations • Supports the preparation of program level documents such as the investigators brochure and DUSR. • Follows important developments and trends in the medical & scientific literature and disseminates updates to the project team and beyond ensuring all involved parties are aware of key developments and the impact

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Director, Clinical Operations

Cancer InsightTrauma Insight

Aug 2020 - Jun 2021 (11 months)

Manage staff in accordance with organizational policies, SOPs, and applicable regulations. Provide oversight and guidance on all projects assigned to clinical team members, planning, assigning, and directing work; appraising performance and guiding professional development; addressing employee relations issues and resolving problems. Monitor departmental staffing needs on an ongoing basis. Direct the interview, hiring, and selection process for clinical staff. Establish methods to develop and evaluate onboarding processes. Develop standard processes to ensure staff have the proper materials, systems access, and training to complete job responsibilities. Collaborate with senior management and cross-functional leadership to improve efficienci

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Clinical Project Manager

Translational Drug Development (TD2)

Nov 2019 - Aug 2020 (10 months)

Manages and oversees day-to-day responsibilities on multiple early phase clinical research trials. Provides expert input in concert with KOLs, scientific and medical leadership regarding study design, endpoint identification and study execution. Acts as the primary point of contact for TD2's sponsors, vendors, clinical research sites, third party organizations and internal departments as delegated by the Sponsor. Ensures compliance with FDA and ICH GCP regulations, Sponsor guidelines, protocol and all internal controlled documents. Tracks and assists with resolution of trial non-compliances, working on corrective and preventative actions as needed. Provides leadership to project related clinical, regulatory, site monitoring, safety, data ma

Clinical Scientist

Array BioPharma

Apr 2019 - Jun 2019 (3 months)

Contributed to authorship of high-level study documents such as protocols, FDA submissions and/or documents supporting abstracts, posters, oral presentations and publications. Contributed to the clinical and scientific background sections of documents, including Investigator's Brochures, SNDAS, CTAs, Study Reports, Clinical Summaries, Clinical Overviews, and other documents. Served in a Project Manager function over all aspects of study operations and execution Lends insight into study design and trial execution Led medical monitoring efforts in reviewing SAE reports, AE and SAE listings, AE coding, concomitant medication coding, medical history coding, tables and listings of safety and efficacy data, and other output from clinical studies.

Oncology Clinical Scientist

BeiGene

Jan 2019 - Mar 2019 (3 months)

Completed assignment, including cleaning of all data in Medidata RAVE via queries and site follow up and achieved data base locks (DBLs) ahead of schedule in approximately 4.5. weeks instead of the anticipated 6-7 weeks. Responsibilities: Functioned in a Project Management capacity related to safety, efficacy, and final data cleaning efforts. Led final data cleaning and (DBLs) for two Phase III PDL1 inhibitor trials with poor efficacy indications from initial data review. Worked cross functionally with executive leadership and other internationally based scopes (PV, biostats, clinical operations, etc.) to lead all DBL efforts to ensure deliverables met and data cleaned to the highest of quality standards. Led entire process via consistent c

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Oncology Clinical Scientist

Execupharm (Assigned to Merck)

Jan 2018 - Feb 2019 (1 year 2 months)

Led cross functional study teams in achievement of key milestone deliverables, including safety and final database lock(s). Co-authored integral protocol amendment impacting entire study design to include changing primary, secondary and tertiary objectives when efficacy data indicated the regimen under study had no efficacy potential. Authored and presented critical, safety specific study data to executive leadership. Functioned in a Project Management capacity including team leadership and all protocol related deliverables. Served as the lead contact of protocol specific clinical team and provided significant contributions towards achieving protocol milestones throughout trial life cycle from start up. to close out across three global, Pha

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Clinical Project Manager (SCD Trials) / Clinical PV & Safety Monitor (all BMT CTN trials)

EMMES Corporation

Jun 2015 - Mar 2017 (1 year 10 months)

Led international protocol leadership teams for BMT CTN 1503 & BMT CTN 1507 in successful progression through Steering, Protocol Review and DSMB Committees. Coordinated and presented at BMT CTN 1507 break out Investigator Meeting at ASH 2015. Received BMT CTN consortium award for leadership in sickle cell disease group trials. Responsibilities: Clinical Project Manager (BMT CTN Sickle Cell group): Served as overall PM of the BMT CTN Sickle Cell group, leading study start up and protocol management for two BMT CTN sickle cell trials (BMT CTN 1503: A Study to Compare Bone Marrow Transplantation to Standard Care in Adolescents and Young Adults with Severe Sickle Cell Disease & BMT CTN 1507: Reduced Intensity Conditioning for Haploidentical Bon

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Clinical Research Coordinator IV

Emory University School of Medicine - Pediatric GI

May 2014 - Jun 2015 (1 year 2 months)

Increased enrollment on pediatric IBD trials (therapeutic and device) by greater than 15%. Facilitated expansion of Emory investigator-initiated trials from single to multi center studies. Improved intra operative protocol compliance amongst OR staff. Responsibilities: Patient Recruitment & Retention: Identified eligible patients for all assigned studies (4 therapeutic, nine nontherapeutic, and three device trials). Conducted informed consent discussions and all subsequent study visit activities with subjects. Worked closely with clinical providers and other hospital service lines and ancillary staff as necessary to ensure proper adherence to and execution of clinical research protocols. Completed all study visits in accordance with applica

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Senior Lead CRA

Children's Healthcare of Atlanta – Pediatric Oncology's Innovative Therapy (Phase I) Team

Mar 2010 - Jun 2014 (4 years 4 months)

Spearheaded successful application process for COG Phase I consortium membership. Nominated as national CRA for several COG trials. Contributed heavily to investigator-initiated trials and efforts to bring them to the multi center level therein. Functioned as a member of an elite multidisciplinary team, identified patients for screening, enrollment, and treatment on a variety of Phase I pediatric oncology trials. Collaborated with various industry and consortium groups as representative for CHOA's then developing Phase I program. Research Conduct & Facilitation: Ensured the execution of phase I clinical trials in strict accordance with protocol, sponsor and/consortium mandates as well as standard GCP and ICH regulations. Worked closely with

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Clinical Research & Operations Projects Manager

2017

Aug 2007 - Oct 2009 (2 years 3 months)

Chaired several abstract review and selection committees Obtained EPIC "super user" credentials Appointed national coordinator for SCDAA and SCDCRN Functioned as the department's sole Clinical Projects Manager, led variety of clinical research and clinical operations projects and initiatives within the division of clinical hematology whilst simultaneously functioning in a comprehensive site monitor/ manager role for Sickle Cell Disease Association of America (SCDAA) and/or Sickle Cell Disease Clinical Research Network (SCDCRN) protocols. Research Coordination & Conduct (in house): LCRA for multiple general hematology registry, repository and/or long term follow up protocols (Phase IVs). Completed recruitment, consenting, study visits (inpat

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