RESUME: Dzandu, James K.

6925 Flint Cove Drive, Dallas, Texas 75248.

Cell Phone Number: 214-566-4603. E-mail: jd64569c@westpost.net
CITIZENSHIP: U.S.A
OBJECTIVE: A Ph.D. Life Scientist seeking a position with top level pharmaceutic
al industry, prestigious medical research center, CRO or FDA to leverage academi
c, clinical research professional training, discovery research and experience to
drive achievement of program goals.
SUMMARY:
* Possess sound scientific knowledge, training in new drug discovery process, c
linical research project planning, implementation, monitoring and report writing
.
* Possess thorough knowledge of GCP, ICH/E-6, and FDA regulations
* Serve as IRB Chairman, review clinical trials for scientific merit and protect
ion of human subjects (21 CFR 50; 21 CFR 56; 45 CFR 46); FDA/GCP and ICH/GCP.
* Possess CLIA-certified, AABB-certified, CAP-approved clinical & Molecular Diag
nostics/DNA Identity Laboratory Director experience; secured competitive grant f
unding in excess of $1,310,000.00; 35 scientific publications and abstracts.
* Strong organizational skills, self-motivated, assertive, able to work independ
ently or as part of a team.
EDUCATION/TRAINING
Wayne State University, Detroit Michigan, USA Ph.D. 1974-1980 Biochemistry Wayne
State University. Management Training CRA certificate 2007-2008 Clinical Resear
ch Professional Training
APPOINTMENTS
2007-2010 Compliance Auditor (Consultant) Dallas Methodist Health System
2007- 2008 Interim Chairman & Consultant, Dallas Methodist Health System (6 mont
hs)
2006-2007 Senior Scientist, Department of Molecular and Cellular Biology Univers
ity of Texas at Dallas
2002-2005 Director, Genetic Services, Sickle Cell Disease Association of America
, Dallas.
1994-2002 Clinical Laboratory Director, Sickle Cell Laboratory, Fort Worth, Texa
s, CLIA ID # 45D0486179
1992-1997 Associate Director, DNA/Identity Laboratories, Department of Pathology
, University of North Texas Health Science Center, Fort Worth, Texas.
1992-1997 Assistant Professor of Pathology, University of North Texas Health Sci
ence Center, Fort Worth,
AWARDS AND OTHER PROFESSIONAL ACTIVITIES
2005-2010 American Society for Advancement of Science-Member
1997 National Institutes of Health (NIH) Invited Grant reviewer: Gene therapy fo
r sickle cell disease
1992-1997 American Association of Blood Banks DNA Laboratory Accreditation Inspe
ctor;
1974-1980 African-American Graduate Fellow/African-American Institute
1974-1980 US Agency for International Development Fellow (AID)
Selected Publications (Peer-reviewed Scientific Journals: 14 publications 20 abs
tracts)
1. X. Yao, S. Kodeboyina, L. Liu, J. Dzandu, J. Sangerman, S. Ofori-Acquah, B. P
ace Role of STAT3 and GATA-1 interactions in *-globin gene expression Experiment
al Hematology, Volume 37, Issue 8, Pages 889-900, 2009
2. Dzandu, J.K., Role of Sialic Acid in Selective Silver Staining of Red Cell Gl
ycophorins: Journal of Applied and Theoretical Electrophoresis. 1, 137-144, 1989
3. Dzandu, J.K., *Deh, ME., Baratt, D. and Wise, G.E. Detection of Erythrocyte
Membrane Proteins, Sialoglycoproteins and Lipids in a Single Polyacrylamide gel
Using a Novel Double Staining Technique. Proceedings of the National Academy of
Sciences, U.S.A. 81, 1733-1737, 1984
Personal Statement
Possess through training, experience and expertise to perform the role of Princi
pal Investigator, Research team leader or Clinical Trial Manager in life science
or clinical project management. Responsible for hypothesis-driven project desig
ns, implementation and evaluation using GCP standards and SOPs to ensure subject
safety, protocol adherence and production of valid study results for FDA IND an
d NDA submissions. Validate or re-formulate relevant standard operating procedur
es based on cross-cutting platforms; conduct discovery research; collect, analyz
e and report project data and present conclusions in meaningful fashion to stake
holders, including internal and external customers, regulatory agencies and prof
essionals. Understand the development process for Drugs, Biologics, and Medical
Devices. Maintain regulatory compliance with FDA submissions/approvals, ICH guid
elines, GMP, GCP, CLIA, CAP and Quality Control and Quality Assurance Programs a
s they relate to primary areas of company enterprise. Effective verbal and writt
en communication skills aimed at optimizing performance at varying levels of com
pany organization, operation and analysis. Able to simultaneously handle multipl
e projects, prioritize work, supervise others and meet deadlines and pre-determi
ned benchmarks. Anticipate project related expected and unexpected adverse event
s. Develop, implement and evaluate contingency plans to mitigate expected advers
e events. Highly skilled in development, implementation and follow-up of correct
ive action plans Maintain cognitive and operational flexibility in functional ar
eas to develop effective time-lined solutions to unexpected difficulties before
they become obstacles to project progress. Possess computer skills including, Mi
crosoft word suite, and statistical software such as SPSS.
Research Support
2005-2008 Health Resources and Services Administration, Child and Maternal Healt
h (HRSA)
* Grant award: $555,000.00-Dr. Dzandu, Principal Investigator
2003-2005 Health Resources and Services Administration, Child and Maternal Healt
h (HRSA)
* Grant award: $375,000.00-Dr. Dzandu, Principal Investigator
2002-2003 Health Resources and Services Administration, Child and Maternal Healt
h (HRSA)
* Grant award: $185,000.00-Dr. Dzandu, Principal Investigator
2001-2002 Texas Department of Health Innovative Grant
* Grant award: $200,000.00-Dr. Dzandu, Principal Investigator
Grants Submitted: SAMSAH: $1,500,500.00 (unfunded)
Skills: Theoretical understanding and hands-on expertise with basic life and cli
nical science research techniques to create new knowledge or find solutions to b
iological problems of interest. These skills include proteomics, genomics, cell
& molecular biology, biochemistry and immunology with special emphasis on discov
ery research. Additional pertinent analytical techniques aimed at finding biomar
kers include, electrophoresis (1 & 2 dimensions), IEF, western & southern blotti
ng; RFLP, multiplex-PCR, nucleic acid-based diagnostics, HPLC, spectroscopy, cel
l culture, transduction, electrophoretic mobility shift assays coupled with tand
em protein mass spectroscopy (EMSA-MS/MS) and clinical laboratory testing. Resea
rch grants proposal development for funding by governments, private and commerci
al agencies with focus on biological research and health service programs.
CLINICAL RESEARCH PROFESSIONAL TRAINING (140 HOURS)
* The drug research and development process, Identifying and reporting of non-se
rious and serious adverse events, principles of data management and query resolu
tion, protocol development, case report form design, and informed consent writin
g.
* Good clinical practices 21 CFR 312 IND, 21 CFR 50 Protection of Human Subjects
, 21 CFR 56 IRB, 45 CFR 46, 21 CFR 54 Financial Disclosure by Clinical Investiga
tors. International Conference on Harmonization (E6) GCP Consolidated Guideline
and (E2A) Clinical Safety Data Management.
* Monitoring method and responsibilities: Systematic approach to monitoring, man
aging essential documents and clinical trial materials. Selecting investigators
and conducting pre-evaluation, study initiation, interim, and close out visits.
Writing pre-visit letters, follow up letters, and site visit reports. Performed
five mock site visits utilizing case studies and wrote example monitoring report
s.
Criteria for Course Completion: Comprehensive course examination, ICH/GCP regula
tory examination, and performing a site monitoring visit identifying 80% of the
deficiencies.
References are available on request.