Fiona Patterson Email and Phone Number

Our Mission:To save, extend and improve the lives of cancer patients and their families through the development and commercialization of innovative and personalized cancer immunotherapies.

Project Manager for three adult leukemia studies, including a global phase III study, led from first patient-in through to enrollment close and interim analysis read out. Leading cross-functional internal team, oversight of CRO, direct management of several ancillary vendors. Personnel management responsibilities and project supervision of other project managers and trial associates.

Developed and implemented a Phase I/II study in a new therapeutic area for the company. Authored departmental processes/SOPs and study start-up documents including: Investigator Brochure, Protocol and source document worksheets. Led the selection process for a new EDC vendor for Avedro and developed eCRFs for database implementation. Performed study data review; working cross-functionally with internal groups and external consultants in a high visibility role reporting into the VP of Clinical Affairs. Managed and supervised personnel.

Program responsibilities for global regulatory agency inspection readiness across 22 studies, resulting in a successful sponsor inspection and new drug FDA approval in Sept 2012. Prepared teams for potential EMA sponsor inspection. Operational oversight of a leukemia phase III study in maintenance and closed out 3 early phase studies in pediatric or adult subjects with solid tumors or lymphoma, provided data for sNDA. Responsible for operational activities related to NDA and MAA submission activities which included authoring supportive documents, reviewing various submission documents, obtaining resources and managing personnel responsible for submission activities. Resulted in on-time successful receipt by regulatory agencies and a new Pfizer Oncology standard submission template. Hired and managed in-house contractors across two different programs.

Project Manager for a pivotal, global leukemia phase III study from last subject enrolled to interim study readout and clinical study report completion. Prepared risk mitigation plans and executed those plans. Led the study team and continued to meet study deliverables and key milestones throughout the Wyeth to Pfizer transition in roles, personnel, systems and processes. Trained and supervised the new study personnel. Nominated by team members and awarded with Individual Performance Awards for outstanding achievements.

Project Manager for a pivotal, global leukemia phase III study through active enrollment to last subject enrolled. Managed critical path activities, including senior management expectations. Managed global vendors. Led the global cross-functional study team, meeting study deliverables.

Project Manager for a pivotal, global leukemia phase III study from first site initiated through active enrollment. Organized and presented at Investigators meetings in EU, Asia and the Americas. Led study team throughout the internal Wyeth monitoring and trial management changes. Retained key study talent by pioneering a unique remote based working agreement for a team member who was moving to the west coast. Due to the success of this pilot remote working for contractors and employees became standard within the department. Hired, trained and supervised internal contractors.

Trial Manager for a pivotal, global leukemia phase III study in start-up, from protocol concept approval, country/site selection to first site initiated. Managed critical path activities, coordinated global cross-functional internal and external resources across 30+ countries including Asia, EU, Africa, North and South America. Selected and managed vendors (IWRS, ECG, analysis labs for clinical endpoints and advertising/recruitment). Led study team meetings, executed trial operational activities globally and authored study documents. Supervised internal contractors and new Clinical Trial Managers working on the study.

Trial Manager for an ongoing phase II, Cardiovascular pediatric nuclear imaging trial, with sites in Asia, South and North America. Assisted another Project Manager with an EU phase IV study in start up. Managed project timelines, CRO, imaging and ECG vendors as well as non-CRO contract CRAs. Reviewed and commented on CRA monitoring reports, performed co-monitoring quality visits to assess sites or CRA contractors. Alerted the Project Manager to a CRF design flaw, thereby preventing delays in endpoint data collection

Trial manager for a phase II multiple myeloma study in close out. Managed lab vendors and contract CRAs, reviewed monitoring reports. CRA monitor for this study and two other Oncology studies in Canada and the US.

Trial manager for a phase II multiple myeloma study in close out and a phase II leukemia study from protocol concept to study site initiation. Assisted the Project Manager with a phase II registration lymphoma study from protocol concept through NDA submission and FDA approval in 2006. Assisted with the execution of several Oncology studies. Managed project timelines. Responsible for study team management. Selected and trained CRO personnel. Managed external data management vendor. Led the team through in-house eCRF design and implementation activities. Planned a US Investigator meeting and led study termination activities. CRA monitor for Canadian and US sites for various Oncology clinical trials and one Atherosclerosis trial. Graduated top of the PPD run CRA class and mentored in-house CRAs.

Assisted a Project Manager in the execution of several NA and EU Oncology (solid tumor and hematologic malignancy) studies from phase I - IV, from study start up through to maintenance. Managed lab vendors and performed CRA training. Authored documents including monitoring tools and IRB responses. Reviewed site regulatory documents and budgets. Presented at US Investigator meetings. CRA monitor for US study sites.

Operated as interim trial manager for a phase I PK and a phase II Oncology study during staff transitions. Assisted a Project Manager in the execution of phase II breast cancer and lymphoma trials from study start up through to maintenance. Performed site budget negotiation. Assisted with vendor selection and managed selected lab vendors. Authored and trained CRO-CRAs on study documents. Led team meetings and site teleconferences. CRA in training.

Managed 4 groups encompassing 36 personnel operating 7 days a week. Managed the associated budgets, people and resources. Reviewed, restructured and streamlined the previously failing Oligo group, resulting in improved group morale, reduced turnaround time and increased customer satisfaction within budgetary and resource constraints.