Kyle Herbert Email & Phone Number

Cambridge, Massachusetts, Us

Waltham, Ma, Us

• Manage conduct of global ph3 registrational cell therapy trial to treat patients with severe virus- associated hemorrhagic cystitis after allogeneic hematopoietic stem cell transplant• Devise and execute efficient, effective clinical trial execution strategies that account for the complex nuances present in the conduct of gene cell therapy clinical trials• Led cross-functional initiative to develop data review strategy and create a data review plan template, achieved through close collaboration with Data Management and Clinical Research teams• Partnered with Quality Assurance, Clinical Supply Chain, and Clinical Research to develop AlloVir’s blinding plan template to ensure study teams clearly capture risks and mitigations related to the study blind• Use objective measures and tools to plan and consistently communicate key clinical trial metrics to senior management• Serve as the Clinical Operations SME for multiple ex-US regulatory submissions• Operational representative on the Global Product Team to inform the integrated product development plan• Leverage strong planning, communication, and creative problem-solving skills to drive timely enrollment while maintaining a state of inspection readiness• Provide mentorship and oversight of Clinical Project Leads and Clinical Trial Associates with a focus on helping them develop clinical operations and strategic thinking skillset• Ensure compliance of clinical trials with federal and applicable regulatory agency requirements• Develop and implement Clinical Operations Standard Operating Procedures for key department processes• Establish clear performance metrics for CRO and vendor partners to ensure accountability and achievement of company deliverables

Waltham, Ma, Us

• Outsourced and managed conduct of ph2 and ph3 multivirus specific cell therapy trials simultaneously within a fully outsourced model including (CRO, Central and Academic Laboratories, ePRO, IRT, Patient Reimbursement, centralized statistical monitoring services)Collaborated with Clinical Research and Technical Operations teams to author AlloVir’s first Cell Therapy Manual (pharmacy manual)• Recruited key Clinical Operations team members to join AlloVir as the company rapidly expanded to support the clinical development pipeline• Developed cross-functional Study Execution Team (SET) model within AlloVir to establish and execute on risk-based approach to study conduct• Maintained accurate clinical trial budgets and participated in recurring financial forecasting exercises

Cambridge, Massachusetts, Us

• Managed conduct of three ongoing ph1 Parkinson’s Disease AAV gene therapy trials (CROs, central labs, imaging central readers, diagnostic equipment suppliers)• Developed study closeout strategy and timeline while simultaneously aligning key internal and external stakeholders• Provided input on Voyager eTMF Veeva Vault launch, and drafted eTMF transition plans• Led Study Management Team (SMT) meetings to align on upcoming study milestones and deliverables• Maintained study budgets, reviewed and approved invoices, and collaborated closely with Clinical Outsourcing, Legal and Finance to drive strategic sourcing of trials• Educated team members and other functions on clinical operations and supplier management best practices

Cambridge, Ma, Us

• Oversaw CROs, central labs, IXRS as well as CRAs to ensure adherence to GCP, study timeline, and budget• Drove completion of key Clinical Operations deliverables in support of Cyclerion’s ph1 First in Human (FIH) CNS trial conducted in the Netherlands• Participated and facilitated preparation for dose escalation meetings for ph1 FIH trial• Managed clinical trial budget• Partnered with clinical outsourcing to drive supplier selection and qualification• Collaborated cross-functionally to develop and draf study plans, study protocols, ICFs, patient facing advertisements• Led initiative, in collaboration with key sr. stakeholders to identify CRO preferred partner• Fostered close relationships with external collaborators including trial investigators, study coordinators, and CROs• Participated in regular data review meetings with a focus on KPIs, safety, PDs, data quality• Mentored junior team members on institutional processes, GCP, and clinical trial management best practices

Cambridge, Ma, Us

Cambridge, Ma, Us

Andover, Massachusetts, Us

• Organized critical research information for clinical trials and ensured compliance with GCP and GDP• Assisted the PI in performing the administrative aspects of numerous ophthalmic clinical trials (source generation, documentation maintenance)• Consented potential clinical trial participants through explanation and review of clinical trial

Cambridge, Massachusetts, Us

• Collaborated with a project manager, a curator, and two project assistants on an NSF-funded nationwide digitization project. Generated thousands of database entries, ensuring accuracy through regular quality checks, and assisted in recruiting additional project assistants to meet project deadlines.

Cambridge, Massachusetts, Us

• Accurately prepared reagents & DNA samples for PCR analysis. Performed agarose gel electrophoresis to evaluate the replicated sections of DNA.