Manager Supply Chain

Fifteen years of Global clinical trial management in Oncology, Neurology, Anti-Invectives, Ophthalmology results oriented motivational leader, with communication, negotiation, creative and analytical skills able to foster teamwork, energize others to higher levels of performance.

Combines cross-functional expertise in:

Protocol writing/feasibility Patient Recruitment Plan Contract and Vendor Negotiation

Clinical Supply Chain Clinical Monitoring Large-Scale Budgets/Finance Plans

CTA Application Consensus-Building Compound Migrations/Transitions

Statistical Analysis Plan Clinical Study Reports Risk Analysis and Assessment

Strategic Vision & Planning Global team management Project Management

Data Management, OC-RDC Team Leadership Process Streamlining

Professional History

Eisai, Consultant Study Manager - Oncology Sept 2010 - present

Cross functionally support adhoc requests in the department, provide support to early development clinical trials, (phase I–III) INDs, sNDAs, NDAs, MAAs providing specific project/study support.

Contract and budget negotiations, patient profile review, data and safety review responding to FDA data requests; develop Informed Consents, vendor oversight: monitors and labs

Provide suggestions for process improvement

Pfizer Inc, Global Clinical Study Manager – Oncology, HIV, Ophthalmology Feb ’08 – Mar ‘10

Managed several global phase trials, including FIH/FIP in HIV, Oncology and Non Interventional Ophthalmology therapeutic areas.

Conducted protocol feasibility, country and site selection, budget clinical supply forecasting, developing site contracts, the development of study documents, etc.

Handled challenging recruitments schema base on geographical region.

Performed risk analysis and developed contingency plan.

Organized Scientific Steering Committee and Investigator Meetings.

Accomplished implementation of alternative process for budget approval while system was down.

Successfully negotiated study start up budget with upper management.

Accomplished EC approval goal as requested by the ECEMA by February 2010

Pfizer Inc, Associate Director /Study Manager –Global Oncology Jan ‘06 –Sept ‘07

Strategically managed 9 global clinical trials across multiple products and various protocol designs at different stages of conduct; evaluated metrics, developed risk analysis and implemented contigency plans to support deliverables.

Determined early phase compound budget requirement and dosing regimens and timelines

Contributed to early coumpound development concepts

Ensured submission of quality IIR proposals supporting scientific, statistical, financial review

Mentored and provided oversight of 8 Study Managers ensuring timely and quality deliverables to colleagues from associate to Associate Director level; success was measured by the quality of their work; capabilities to host IM meetings, meeting timelines and in their promotion and future career development.

Built & enhanced business partnerships internally and externally (EORTC & KOLs)

Aligned Pfizer and EORTC strategic goals, contracts, safety and endorsement processes

Focused organization and leadership team to drive consistency through representing the NY office at the Global Training Committee and chairing Local Training Committee, participated in data collection, processing, analysis and publication standardization.

Challenges included: managing a committee of study managers with a wide range of experience from associate to Director(soon to be retiree), creating a team environment, a forum for open debate, exchange of ideas and practise across all therapeutic areas to develop tools that could be used in a generic fashion across operations department.

Accomplishments can be measured by the development of supplementary training tools; SM Checklist, Lunch & Learns, Learning Days , Curriculum Development, Training compliance calculation & Mentorship Program, all informal documents but boost moral during change.

Pfizer Inc, Global Clinical Study Manager, Oncology Pain&Inflammation Aug’04- Jan‘06

Managed Global Campto program transition (12 sponsored, 300 supported trials) from Sanofi-Aventis- Pfizer developing an external title of ‘Campto girl’

Collaborated extensively with partners’ key stakeholders,(safety, clinical, marketing, legal, finance etc)

Integrated all key processes, identified constraints and resolutions(safety, supply chain etc)

Updated Contracts with CRO, Independent Research Grants, and, Cooperative groups

Transitioned and reconciled global and local country multi-million budgets and contracts

Accomplished successful transition with no disruption to business, manufacturing, payments, enrolment rates with clear communication to all external customers.

Managed Petacc3 adjuvant CRC;30 countries, 3,278 patients

Developed Translational Research protocol aligning KOL and medical strategies

Completed Clinical Study Report and QC of final document with Medical Writer

Facilitated Investigator Meetings, DSMB, attended Advisory Board Meetings

Represented Medical Team at annual Pattack conference, defending Celebrex

Managed External partnership grants; EORTC, UKCCSG

Pfizer Inc, Global Clinical Program Operation Manger, Pain & Neurology Feb‘02-Aug‘04

Lead the Lyrical global program, including development of pain screening tool

Transitioned the program from multiple international R&D sites to Post Marketing

Lead collaboration of clinical, statistics, operations, outcomes research, programmers, in the development of standard collection, clean, programming and reporting

Taskforce member of - EDC, electronic SAE reconciliation tool, standard electronic data validation, SDLC (Software Development Lifecycle) rollout & Data Management training

Mentorship and oversight of junior staff

Pfizer Inc, Global Clinical Database Associate, Anti-infective Apr ‘00-Feb ‘02

Data Manager for 5 Azithromycin protocols

Standardized study documents, OC database setup and edit checks

Validated Lab Checks in SAS AF application and provided training documentation

Closed out approximately 70 legacy studies, resolving QA observations

Mentorship and oversight of junior staff

Summary of Previous Professional Experience

Hoffman La Roche UK&NJ Clinical Pharmacology Data Manager April ’98-April ‘00

SmithKline Beecham, UK, Clinical Data Co-ordinator, IBS & Diabetes April ‘97- April ‘98

Kings College London, CRC Data Manager Mar ’96 - Sept ‘96

London Analytical Testing Laboratory Lab Technician Sept ’95 – Mar ‘96

University College Galway Microbiology Research Assistant Oct ’93 – Aug ‘94

Educational Details

National 3 year Diploma in Science, Sligo Regional College Sligo Ireland 1995

PERI Advanced Concepts in Oncologic Drug Development 2004

Current Concepts in the Management of Colorectal Cancer 2005

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