-Serve as the leader on the transition change and integration of Hospira’s legacy projects into Pfizer’s system and processes. -Provide Study Team Leadership.-Support Practical Clinical Study Design and development of protocols-Provide Operational Oversight for Global Medical Affair studies.-Lead Quality/Risk Management Activities – Proactively identify risks to delivery or quality and ensure that appropriate risk mitigation plans are in place.-Provide Cross Pfizer Coordination – Provides guidance on availability of expertise on Pfizer processes and systems with access to Pfizer subject matter experts to support AP/CRO tasks and issue resolution.-Provide Financial Oversight – Forecast and manage high level clinical trial budgets and support invoicing approvals as needed and dependent on current process.-Act as a SME (Subject Matter Expert) on the Legacy Hospira Biosimilar products.-Support Senior Management in Biosimilar submission to the FDA. -Mentor junior team members.

-Provided R&D support for the overall company strategy of Biosimilar development. -Provided overall oversight of Observational Studies, including vendor management.-Managed overall study budgets to maintain budget variance no greater than +/- 5%.-Managed overall study timelines. -Worked with Medical Affairs to develop study concept documents, synopses, and protocols.

- Worked in the development of department and company SOPs and work instructions.- Successfully executed Phase I-IV and other approved US and global clinical studies, including complex protocols, according to ICH-GCP and required regional regulations.- Successfully closed Phase I-IV studies.- Successfully managed the day to day operation of study including maintaining study timeline. - Overall management of assigned study conduct, including oversight of the CRO and all other clinical vendors. - Trained and mentored of junior personnel and new hires.- Managed full scope of study conduct ensuring studies were conducted according to the Code of Federal Regulations, Good Clinical Practices, ICH Guidelines, local regulatory requirements, and company SOPs.- Coordinated with all relevant groups to develop and manage clinical project timelines and overall global clinical study budget greater than 80 million dollars.- Wrote study protocols and amendments in collaboration with cross functional groups.- Wrote Informed Consent Form and PGx Forms in collaboration with cross functional groups.- Participated in the selection of CRO and all clinical vendors for assigned studies and budget/contract negotiations.- Participated in country feasibility assessment for a study. Led feasibility assessment from the Sponsor side.- Managed study budgets from contract negotiations, change orders, and invoice payments, to final budget reconciliation.- Reviewed and input data to Clinical Study Report.- Participated in Clinical Operations initiatives to enhance processes and revise/develop SOPs.- Led cross-functional study working groups and meetings.- Global Lead for the clinical operation team in preparation of a potential FDA program inspection. - Participated in a mock FDA inspection ending with favorable results.- Successfully closed out multiple studies/programs including termination of a program.- Worked on an initiative to develop Risk Based Monitoring for the company.

- Assisted the CRA with monitoring visits.- Facilitated the review of recruitment materials between the Sponsor, site and IRB.- Critically reviewed regulatory documents for quality and completeness in accordance with appropriate regulations and the study protocol. Ensured all required documents are archived appropriately. - Monitored status of CDA/site contract negotiations and finalization as it occurs- Served as the first point of contact for clinical sites and study team members in the collection and management of regulatory documents. - Worked closely with the study team in organizing and executing pre-study activities.