Fiona Kearney

MSc, Senior Director, Peri- and Post-Approval Research Operations

Fiona has 22 years experience in the pharmaceutical industry, 14 of which have been in leadership roles within the peri/post approval space. She currently has departmental financial responsibilities, providing executive support to the General Managers of PPA Interventional (INT) and Non-Interventional Studies (NIS) to meet departmental AOP and PPD-defined annual financial targets. Fiona is also responsible for supporting the team of project managers and oversight directors in financial stewardship. She ensures that proactive identification of finance project risks and potential contingencies impacting time, quality, and cost of deliverables are effectively managed and escalated through appropriate escalation pathways. Fiona also acts as Peri and Post Approval Operational lead for client portfolios as business need requires. In this role, she preserves the client relationship and chairs portfolio and KPI review meetings, with emphasis on proactive risk mitigation.

Prior to this, Fiona led the Cardiovascular and Metabolic IIIb/IV franchise of work where she provided direction and management to oversight directors assigned to franchise projects and directs and supports global cross-functional Medical Affairs project teams in meeting and exceeding client expectations.

Fiona joined PPD in late 2009 from another large CRO, where she worked as a Business Manager/Project Director focusing on peri/post approval proposal development and oversight of large peri/post approval studies. Prior to this, Fiona had responsibility for the UK and Italian peri/post approval project and clinical management teams at a medium-sized CRO, with her own financial P&L. Under her leadership, the department grew from approximately 10 to 40 individuals with significant increase in revenues. Fiona started her career as a clinical trials coordinator in diagnostics with a J&J company in 1997, moving to project management in 2000 with a medium size CRO.

Throughout her career, Fiona and her teams have been responsible for the delivery of pan-European and global clinical research programs in accordance with ICH-GCP and other applicable guidelines across a variety of different therapeutic areas, including Cardiovascular, Dental, Dermatology, Device, Endocrinology/Metabolic, Genitourinary, GI, Infectious Disease, Nervous System, Oncology, Renal, and Respiratory as well as experience in Medical Device, Pediatric, and OTC compound studies.  Fiona has a masters degree in medical biochemistry.