Cheryl Farello Email & Phone Number

Cambridge, Ma

Facilitates program team meetings comprised of core functional representatives including but not limited to: Clinical Operations, Regulatory affairs, Regulatory, Medical Affairs, Nonclinical, Clinical Pharmacology, CMC and Finance. Works alongside Program Lead on IND-enabling program regarding status of study-related deliverables, timelines, and issues. Drives the development, maintenance and execution of the Integrated Development Plans (IDP) and Monthly Dashboards. Ensures alignment on the messaging of such reports with respect to the Clinical Development Plan and Target Product Profile. Assists with ad-hoc process improvement projects.

Lynnfield, Ma

Cambridge, Ma

Manages three gene therapy programs across all functional teams to ensure that deliverables and timelines are met. Scope includes nonclinical development through regulatory submissions (BLA, IND), commercialization and post-marketing. Advanced Gantt preparation skills and proficiency working with project management tools (MS Project, One Pager Pro) for tracking purposes.

Lexington, Ma

Plan, monitor and integrate robust integration team strategy for combining Global Drug Safety organizations for both Shire and Baxalta. Oversee execution of ten work-streams ensuring that project is on time and within budget. Work-streams include the following: Alliance Management, Case Processing, Clinical Trials, Compliance, International Local Operating Countries (LOCs), Process & Training, EU QPPV, Risk Management, Safety Database and Safety Surveillance. Work closely with Work-stream Leads and individual contributors accountable for project milestones and timelines. Provide support for weekly meetings by preparing meeting agendas, slides, tracking action items and meeting minutes. Develop qualitative risk assessment and in doing so track mitigation for such risks. Accountable for tracking interdependencies within GDS and external cross functional teams. Represent GDS at weekly R&D Integration team, Integrated Management Office (IMO) meetings. Ensure major milestones are entered and updated in proprietary WAVE tracking tool.

Cambridge, Ma

Cambridge,Ma

Responsible for identification, planning and execution of inter/intra departmental project management initiatives globally for Safety & Benefit Risk (SABR). Initiatives may include product launches, filing activities, regulatory commitments. Responsible for the oversight of department's $90M annual operating plan (AOP), and resource planning and represent SABR as part of the Development operational team acting in partnership with and advocating for SABR department needs as they pertain to budget and resource planning. Responsible for ensuring the effective negotiation & timely preparation of short-term department contracts & agreements in accordance with procedures and legal requirements.

Developed, maintained and oversaw all research support functions, processes and tools. Research support functions included project management, and research associates; these functions provided support across epidemiology, pharmacovigilance, risk management, and i3 Aperio projects

Participated on core cross functional teams leading business process improvements and change initiatives across the full lifecycle of drug development from lead optimisation through full lifecycle management.

Participated on core cross-functional teams leading business process improvement and change initiatives across the full lifecycle of drug development, from lead optimisation through full lifecycle management.

Developed and implemented a statewide West Nile Virus surveillance tracking system. Provided scientific and operational supervision of data collection to produce scientifically sound reports at state and local levels.

Masters, Veterinary Epidemiology Magna Cum Laude

Bachelor Of Science, Pre-Vet Medicine, Magna Cum Laude

Associates In Health Sciences, Veterinary Technology, Summa Cum Laude

Activities and Societies: Animal Rescue

Mathematics