Technical Group/Project Manager, Financial/Contracts Analyst

RESUME of Lee Anna Loehr, M.S., M.A.

P.O.B. *****1 • The Woodlands, TX 77393-0701 • 713-***-**** • *******@*****.***

SUMMARY HIGHLIGHTS

• Effective & Efficient Manager of Virtual & On-site Development Teams

• 20+ Years in Full-Service Research & Product Development Programs

• Demonstrated Quantitative, Qualitative Analytical Skills

• Collaborative Contributor, Excellent Communicator, Intuitive Leader

• Proven Excellent Executive Support for all Business Unit Applications

PROFESSIONAL EXPERIENCE

INDEPENDENT CONSULTANT (Jan 2007 – Present)

PRIVATE LAW PRACTICES (Jan 2007 – Apr 2007; Jan 2011 – Feb 2014)

GENERAL FIRM MANAGEMENT (Jan 2007 – Apr 2007; Jan 2011–Feb 2014)

• Managed all ongoing firm financial and accounting deliverables

• Generated annual operational budgets, monthly customized variance tracking reports

• Audited Chart of Accounts, Vendor/Client AP/AR filing systems, bank & IOLTA accounts

• Designed & successfully implemented customized financial metrics reporting systems

• Critiqued and prepared support for multiple external regulatory agency financial audits

• Created executive synopses for complex tax and credit liability scenarios

• Successfully restructured ~$1M in liabilities, achieved ~80% debt reduction

• Negotiated modification, reinstatement of defaulted US Treasury and SBA loans

• Oversaw legal practice management software contracts (LexisNexis, Thomson Reuters)

• Advised Sole Proprietor, Sr. Partner on management initiatives

• Coordinated in-house team building, practice development activities.

BUSINESS LAW - BUSINESS AND CIVIL LITIGATION (Jan 2011–Aug 2013)

• Analyzed client holdings, generated sophisticated quantitative financial scenarios

• Reviewed business contracts for new clients and ongoing lawsuits

• Researched best practice/business development & marketing strategies.

FAMILY LAW (Jul 2012-Feb 2014)

• Monitored CPS case management at on-site family visits & court appearances

• Managed Family Law Opposing Counsel Requests for Production and Discovery

• Utilized practice management software (Clio) for billing and matter management

• Tested cross-platform financial accounting integration (Clio/QuickBooks/Quicken)

• Secured urgent-need Family Law client support resources (financial, legal, health)

• Provided start-up strategy, operational detail for sole-proprietor Family Law practice.

TRUST MANAGEMENT (Jul 2012-Dec 2013)

• Managed high volume, high value client-based trust financial transactions

• Analyzed trust cash flow

• Implemented asset management & fraud strategies

• Monitored client medical liability scenarios, analyzed insurance reimbursement.

BIOTECHNOLOGY/DEVICE COMPANIES (Sep 2009 – Feb 2010)

• Developed multiple analysis plans for ongoing Ph II-B U.S. cell therapy clinical trials.

• Provided CRO management plan for clinical development program

• Interpreted statistical analyses, harmonized reporting practices for medical writers

• Wrote analysis plan; analyzed multidimensional data for international manufacturer.

SR. PROJECT MANAGER/SR. RESEARCH ASSOCIATE (Jun 2008 – May 2009)

inVentiv Clinical Solutions, The Woodlands, TX (a large global publicly–held BioPharma CRO, specializing in early stage clinical development for devices, drugs and biologics).

Hired as permanent Regulatory/Alliance Manager to co-develop, manage and execute all sponsor-driven regulatory strategies for multiple small-molecule sponsor INDs; reported to V.P. of Regulatory and Emerging Biotechnology. Company was a small, privately held CRO undergoing corporate reorganization after recent acquisition by large public global CRO. Also served as interim Sr. Project Manager, reporting to Sr. Operations Director, for same sponsor’s new/expanding in-house full-service phase III programs (~$5M, ~60 sites) in start-up phase; all related work terminated due to regulatory hold for safety issues.

PROJECT MANAGEMENT DIRECTOR/QUALITY SPECIALIST (Aug 2003 – Dec 2006)

DelSite Biotechnologies Inc., Irving, TX (a drug-delivery research subsidiary to a publicly-held raw materials supplier, specializing in vaccine development).

Reported to the President as Quality Specialist (10 mos.) on start-up management team charged to transform non-GxP research laboratory operations into FDA-regulated vaccine manufacturer; achieved milestone for planned role change to Director of Project Management upon completion of grant awards in May 2004. Oversaw executive and corporate planning including most business functions as well as R&D operations including regulatory submissions, grant management and manufacturing processes and vendors (~ 2 yrs). Unanticipated changes in parent company’s business objectives led to leadership change and ultimate dissolution of both companies; resignation submitted 6 mos. after initial changes due to relocation of facilities.

PROJECT DIRECTOR, Pharmaceutical Biology/Functional Genomics (Sep 2000 – Mar 2003)

Lexicon Genetics, Inc., The Woodlands, TX (a medium-growth publicly-held genomics technology company specializing in early identification of clinical development targets).

Managed major PhRMA contracts for emerging pharmaceutical research programs, acting as external sponsor liaison and project manager for all contractual deliverables and internal customer software development programs supporting pharmaceutical biology groups (sponsor & CROs). Managed full life-cycle development of licensed informatics product. Reported to Sr. V.P., later reorganized into company-wide Alliance Management group. Contract options not renewed due to sponsor’s involvement in unrelated lawsuit resulting in significant fines and reduction in force for associated managers.

STATISTICS AND DATA MANAGEMENT DIRECTOR (Sep 1998 – Jul 2000)

Zonagen, Inc., The Woodlands, TX (a small publicly-held biotechnology company specializing in the development of male and female reproductive system therapies).

Hired to manage and oversee regulatory submission compilation and application review process under joint marketing partnership with major PhRMA company; served as statistician/operations consultant on multi-disciplinary internal and external teams for two related marketing applications; co-developed internal centralized regulatory filing system (paper and electronic); reported to V.P. of Clinical and Regulatory Affairs. All divisions ceased work due to FDA hold for safety issue.

SENIOR/MID-/ASSOCIATE STATISTICIAN (Jun 1993 – Sep 1998)

PPD, Inc. (aka Pharmaco, Inc; Pharmaco LSR), Austin, TX (a large global publicly–held BioPharma CRO, specializing in full-service programs for all stages of clinical development for devices, drugs and biologics manufacturers).

As Biostatistics’ intern with advanced SAS programming skills, apprenticed under Sr. Director of Biostatistics then hired into department full-time upon graduation with M.S.; rapidly promoted under V.P. of Biostatistics to senior positions/responsibilities; managed multiple large study teams (up to 25-30 FTE) for clinical data management, analysis, reporting and submission compilation of final deliverables (databases, ad hoc executive requests, statistical reports, fully integrated regulatory submission quality reports; included numerous therapeutic indications for mostly mid-late phase large studies; served as quantitative lead for multi-disciplinary teams including QA, QC, Medical Writing, early CANDA electronic submission, EDC, programming and data standardization initiatives; resigned to work with sponsor company on select NDA submissions. Also served as ASA officer and volunteer analyst at Shiver’s Cancer Center Tumor Registry.

STATISTICAL CONSULTANT (Aug 1990 – Dec 1991)

JLA, London, UK (a privately-held management consulting company).

Provided comprehensive statistical consulting services including design, analyses, executive reporting for $10M+ public transportation project.

STATISTICAL PROGRAMMER.ANALYST (Mar 1988 – Jun 1992)

New Mexico State University, Las Cruces, NM (a land-grant state university).

Hired after M.A. graduation with 50%/50% appointment to graduate school academic department (Experimental Statistics) and University Statistics Service Center (Tenured Faculty Research Support). Consulted on experimental design and methodology at all stages of novel research across broad range of applications (served all research/academic/co-operative extension faculty and graduate department programs including Industrial Engineering, Agriculture and Natural Sciences, Finance, Psychology); utilized diverse statistical methodology for exploratory, designed and observational studies including all general linear models (single/repeated measures/time series) as well as factorial and discriminate analyses; employed expert SAS programming skills, extensive data interface knowledge and novel SAS/Fortran/COBOL programming solutions.

EDUCATION

• M.S., Statistics, University of Texas, Austin, Texas

• M.A., B.S., Mathematics, Eastern New Mexico University, Portales, New Mexico.

PROFICIENCIES

• All general electronic database, management systems and enterprise system platforms

• Microsoft products (Office, Outlook, Word, Power Point, Excel, Access, Project)

• Statistical software: SAS (Base, Stat, Graph, Macro), BMDP, SPSS

• Adobe desktop products (Photoshop, Illustrator)

• All social media platforms (Linked-In, Google, Twitter, Facebook)

• Client Management/CRM software.

Updated July 2014, expanded detail/CV available upon request.

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