James H. Dailey
Old Greenwich, CT. 06870
Email: ac41rv@r.postjobfree.com
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.
Competencies
Drug Development Metrics
Project Management
Microsoft Office Suite
SAP Experience
Cost Containment
Gantt Analysis
Clinical Contracting
Benchmarking
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
Education:
Baruch College CUNY; BSBA, Cum Laude
CPA NY State