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Project Management Manager

Greenwich, Connecticut, 06870, United States
April 05, 2018

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James H. Dailey

** *** ***** ****

Old Greenwich, CT. 06870


Cell: 203-***-****

An experienced accountant with over 20 years of experience in pharmaceutical development project management and project cost control. Financial expert on teams that developed two NCE blockbuster compounds and five 505(b)2 sNDA products. General accounting knowledge includes full responsibility for GAAP financial statements.


Drug Development Metrics

Project Management

Microsoft Office Suite

SAP Experience

Cost Containment

Gantt Analysis

Clinical Contracting


Foreign Exchange Risk

Professional Experience

Roivant/Axovant Sciences Inc., New York, NY

Pharmaceutical company acquiring and developing late-stage treatments for dementia disorders

Senior Director Project Management January 2015 – May 2017

Responsible for establishing and tracking project timelines and resources across portfolio of CNS new chemical entity NDA programs. Administered weekly project team meetings to assure cross-functional and senior management updates were communicated timely and consistently. Assist the Chief Development Officer and Project Team Leaders in strategic decisions to control project duration, cost and risk. Review and approve all significant project resource issues for efficiency and effectiveness and establish and track against performance metrics. Work with newly formed development departments to assure that resource needs were appropriately considered and included in organizational budgets.

Managed investments in all programs totaling $270 mm across Clinical, Nonclinical, Chemistry Manufacturing and Control and Regulatory efforts. Utilized multiple project management tools (MS Project, Primavera and Excel) to update program timelines and budgets with latest information.

Managed outsourcing and procurement activities for major CRO, CMO, and consulting services vendors. This includes: establishing and distributing contracting templates; obtaining bids; holding bid review meetings; finalizing initial contract and change order terms and monitoring and confirming key performance indicators and milestones.

Integral to providing support for largest biotech initial public offering in 2015

Team initiated international phase 3 program (First Patient Screened) 10 months after acquiring compound. Efforts included generating clinical drug supply.

Initiated 3 additional phase 2/3 programs in Lewy body dementia in six months after Alzheimer’s program.

Established document control process to convert approximately 200 legacy studies from previous sponsor for Axovant NDA submission for Alzheimer’s Disease.

Purdue Pharmaceuticals, Stamford, CT

Pharmaceutical company developing novel and reformulated pain treatments.

Senior Manager Clinical Finance September 2010 – June 2014

Responsible for budgeting and tracking expense of clinical trials as well as internal resources devoted to trial management. Responsible for validating clinical study estimates, reconciling actual study costs to forecast study costs, and financial review of change orders. Provide input to operational and outsourcing groups regarding contract negotiations for services.

Managed investments in all programs clinical studies totaling $230 mm across 73 active studies

Managed estimated internal effort required to manage studies totaling 78 full time employees

Modified existing financial analyses to include consideration of key study metrics

Finance member on teams that successfully filed reformulated Oxycontin, extended release Hydrocodone

Regeneron Pharmaceuticals, Tarrytown, NY

Biotech company developing monoclonal antibodies for wide range of indications.

Senior Manager Clinical Finance August 07 – November 2009

Responsible for all budgeting of clinical trials, including obtaining initial approval of budgets from Senior Management. Responsible for forecasting clinical study costs, reconciling actual study costs to forecast study costs, and analyzing what-if scenarios regarding proposed study changes.

Pharmaceutical Special Projects Group

Small group of dedicated, successful pharmaceutical development experts who provide high-level consulting expertise. Each member provides expertise in specific drug development area including Non Clinical, CMC, Clinical and Regulatory Interaction. Core members of team have worked together since 1992.

Financial Expert November 03 – August 07

Provide general financial and project management consulting services to development stage pharmaceutical companies. Provide analysis of program timelines, costs, and interdependent activities for Board of Directors.

Establish SOPs for contract and payment review and approval.

Provided rationale for $20mm secondary stock offering for client (Axonyx)

Contained costs via outsourcing expertise in development effort allowing client to retain $38mm in capital

Negotiated all outsourced CRO and other development service provider contracts for favorable terms

Assure key document processing on a timely basis

Andrx Labs Inc., Hackensack, NJ

Subsidiary of generic drug company established to develop brand products.

Director, R&D Finance September 01-November 03

Responsible for general financial duties (including Sarbanes-Oxley attestations to senior management) for clinical development subsidiary of Andrx. Also assumed general project planning and management responsibilities.

Development team financial expert – negotiated/outsourced terms for all CRO, site, lab and packaging contracts. Monitored and approved payments to vendors

Managed three compounds through successful 505(b)2 applications, and one compound through MAA application.

oAltoprev (hypercholesterolemia treatment) – managed investment of approximately $25mm

oFortamet (diabetes treatment) – managed investment of approximately $20mm

oValdrx (Depakote treatment for epilepsy, migraine headaches) – managed investment of approximately $1 million

All compounds filed on time, on budget.

Eisai Inc. Teaneck, NJ

International pharmaceutical company providing treatments for a variety of indications. Major products include treatments for Alzheimer’s Disease and Gastroesophageal Reflux disease.

Senior Project Planner April 2000-July 2001

Provide Project Management in matrixed environment across company drug development portfolio. Establish performance metrics to determine areas of internal and external (vendor) excellence.

Senior Manager, R&D Finance May 1993–March 2000 Responsible for development costs for new molecular entities in the United States and Europe. Responsible for general accounting, including financial statements, audit reports, payroll, internal management reports, the consolidated US financial statements. Responsible for negotiating financial agreements with Contract Research Organizations (CROs)

Aricept (Alzheimer’s Disease treatment) - managed investment of approximately $60 million through approval, Phase IV

Aciphex (stomach acid secretion treatment) – managed investment of approximately $50million through approval, phase IV

Developed cost methodology for clinical trials that subsequently became worldwide standard

Implemented Primavera P3e software – project management software designed to track resource allocation and project progress across company portfolio


Baruch College CUNY; BSBA, Cum Laude

CPA NY State

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