Senior Clinical Research Scientist in NYC Resume Mark Rudinski by MarkRudinski


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									                                          Mark S. Rudinski, Ph. D.
                                             Morristown, NJ 07960
                              | 201-787-4150

                            CNS | Oncology | Blood Coagulation | Cardiovascular
Knowledgeable and experienced Scientific Liaison who has a demonstrated history in practical scientific research
and clinical operations protocol design & development in various therapeutic areas. Skilled at analyzing data and
providing recommendations on clinical trial activities and related regulatory compliance with GCP practices and
corporate protocols. Highly adept at creating and reporting metrics on project management and performance.
        Hold a patent for ‘Chimeric Mammalian NPY Y5 Receptors’ obtained with a team of scientists in 1999.

FOREST RESEARCH INSTITUTE, Jersey City, NJ on assignment for Precept Life Sciences 3/2012 to
September/Contract assignment concluded.
Senior Clinical Scientist- Neuroscience Clinical Development
    Executed study start up activities for Phase 2 Pediatric Autism Program. Identified program sites, customized
    Informed consent for the EU and local IRB’s, managed ECG vendor program wide. Presented at Investigators
    Meeting, review of protocols, and site qualification documents.
MERCK RESEARCH LABORATORIES (acquired Schering-Plough in 2010), Rahway, NJ 1990 – 12/2011
Senior Clinical Scientist - Neuroscience and Ophthalmology Clinical Research (1/2010 – 12/2011)
    Planned and executed Phase II and Phase III clinical trials. Authored protocol concept sheets, synopses and
    clinical protocols for Parkinson’s Disease, Multiple Sclerosis, Neuropathic Pain and Major Depressive Disorder.
    Generated and implemented Data Safety and Monitoring Board Charter for Phase II/III Parkinson’s Disease
    Clinical Trials. Participated in DSMB meetings resulting in the acceleration of clinical studies.
Senior Clinical Scientist - Schering-Plough Central Nervous System Clinical Research (5/2006 – 1/2010)
    Liaise and communicate with clinical operations, data management, statistics, drug safety, and regulatory areas
    Maintained contacts with key opinion leaders and organized formal and informal advisory board meetings.
    Contributed to responses for US and foreign Health Authority queries for study initiations and yearly reports
    to authorities as required (i.e. Investigator Brochure Updates, IND Annual Reports and Safety Reports).
    Participated and contributed extensively to Strategic Development and Clinical Development Plans.
Project Manager - Global Project Management (8/2004- 5/2006)
    Acted as Oncology Project Manager for successful line extension of Temozolomide in the US.
    Tracked operational and clinical budgets for assigned projects and created reports to communicate status
    Collaborated with source area representatives for product development and approval.
    Established agendas, published meeting minutes and tracked project timelines
    Acted as a SPRI liaison to USAN and served as a Discovery and CNS Licensing Lead Generation Team member
    Served as Project Manager for CNS Licensing Systems, provided scientific expertise and coordinated with
    business management to review candidates and make recommendations on viable candidates for licensing.
Associate Manager - Strategic Planning & Research Project Management (5/2001-8/2004)
    Designed and executed activities supporting Phase I to Phase III studies culminating in product registration
     Participated as a member of specific Project Teams and coordinated preclinical and clinical areas activities.
Principal Scientist - CNS Department Biological Research (1995 – 5/2001)
    Planned and coordinated development projects in the Central Nervous System Therapy Area.
    Led CNS/CV molecular biology department in the area of obesity, energy homeostasis and neurodegeneration
    Performed cloning, characterization, expression of human BACE 2, human and rat melanocortin receptors
    with development of melanocortin research program, neuropeptide Y receptors and the human leptin gene.
    Devised and constructed promoter screening assay system, eukaryotic gene expression and vector analysis.
Associate Principal Scientist - Department of Pharmacology (1992–1995)
    Managed and trained staff and reported research results in staff meetings.
    Laboratory head for the Cardiovascular Department molecular biology laboratory
Senior Scientist - Department of Pharmacology (1990- 1992)
   Designed and implemented RT/PCR quantitation assays, cloned cDNA and genomic molecules via PCR, in vivo
   gene transfer, ELISA design, analyzed transcriptional, regulation, transactivating factors and mechanisms,
   expression cloning, cDNA library construction, screening, automated DNA sequencing, screening compounds.
    Provided bioinformatics support for the CNS/CV department performing research in public and private
    databases. Collaborated with scientists in projects emphasizing CNS/CV therapeutic targets.

U.S.Patent #5985616 for “Chimeric Mammalian NPY Y5 Receptors” Parker, E.M., Strader, C.D., and Rudinski, M.S.
(November 1999).

University of Washington, Seattle, WA - Postdoctoral training, Department of Biochemistry           1986 -1990
Purdue University, West Lafayette, IN - Ph.D. in Biology, Department of Biology                           1986
The Ohio State University, Columbus, OH - M.S. in Microbiology                                            1978
Seton Hall University, South Orange, NJ - B.S. in Biology, Department of Biology                          1976

University of Washington, Seattle, WA, Senior Fellow                                               1986- 1990
Laboratory of Professor E. Davie, Department of Biochemistry
   Structured function studies of recombinant blood coagulation factors Protein C and Factor X. Eukaryotic gene
   expression and vector design. Site-specific mutagenesis to generate novel cDNA mutants and protein
   Analyzed recombinant proteins and immunological detection techniques. PCR amplification of DNA and probe
   design. Mammalian tissue culture expression of designed proteins. Molecular cloning, cDNA library
   construction and screening, DNA sequencing.
Purdue University, West Lafayette, IN, Graduate Research Assistant                                    1980- 1986
Laboratory of Prof. H.E. Umbarger, Department of Biology
   Performed Studies of the IlvBN operon in E. coli K-12. Strain construction and analysis, prokaryotic vector
   design, cloning, mutagenesis and nucleotide sequencing. Expression and analysis of mutant proteins.

Service Activities:
Co-organizer of the Biochemical Pharmacology Discussion Group of the New York Academy of Sciences Symposia
entitled Molecular Mechanisms in the Pathology of Obesity October 27, 1995.
Co-organizer of the Biochemical Pharmacology Discussion Group of the New York Academy Sciences Symposia
entitled: Diseases of the Vascular Wall: Novel Approaches in Treatment March 24, 1992.
Member Peer Review Committee-American Heart Association/New Jersey Affiliate. 1994-1996.

Professional Activities
   Managing for Achievement, Introduction to Managing People, Managing for Effective Performance,
   Comprehensive Project Management, Effective Supervisory Skills, PERI Course –Decision Points in Drug
   Development: Discovery to Launch, PERI Course-Project Management in the Research-Based Pharmaceutical
   Industry (earned Pharmacy Continuing Education Certificate), Linkage Inc. course-Leading High Performance
   Teams, CRF 21 Part 11 Training-Electronic Signatures.
Professional Activities, Continued
   Participated in technology assessment including evaluation of various technologies offered by Acadia
   Pharmaceuticals, Aurora Biosciences, Heartland Biotechnology, Bunsen Rush Laboratories and the University
   of Michigan. Communicated with company scientists and representatives, evaluated the technology and made
   recommendations to management regarding the suitability of the technology for a given drug development or
   research application.
    Task Force on Bioinformatics Committee member. Responsibilities included identifying and interviewing
    senior staff candidates for bioinformatics positions, and serving as the bioinformatics operating committee
    member for the CNS/CV department, design and implementation of a web page detailing the known
    positionally cloned human genes.
    Developed and implemented a department wide DNA sequencing facility. This entailed purchase of
    equipment, design of laboratory space, training of personnel and maintenance of the facility 1994-1996.

Parker, E.M., Babij,C.K., Ambikaipakan Balasubramaniam, Burrier.R.E., Guzzi, M. Hamud,F., Mukhpadhyay,G..
Rudinski,M.S., Tao,Z., Tice,M., Xia,L., Mullins.D.E., and Salisbury, B.G.“GR23118 (1229U91) and other analogues of
the C-terminus of neuropeptide Y are potent neuropeptide Y Y1 receptor antagonists and neuropeptide Y Y4
receptor agonists.” European Journal of Pharmacology, 349 (1998) 97-105
Hwa, J.L., A. Fawzi, M.P. Graziano, L. Ghibaudi,P. Willams., M. Van Heek, H. Davis, M.Rudinski, E. Sybertz, and C.
Strader. “Leptin Increases Thermogenesis and Selectively Promotes Fat Metabolism in ob/ob Mice”American
Journal of Physiology 1997.April;272 (4Pt2):R1204-R1209.
Foster,D.C.,M.S.Rudinski,B.G.Schach,K.L.Berkner, A.A. Kumar, F.S. Hagen, C.A. Sprecher, M.Y. Insley, and E.W. Davie.
(1987 "Propeptide Of human protein C is necessary for gamma-carboxylation" Biochemistry 26:7003-7011.
Rudinski,M.S.(1986)"Genetic and physical analysis of the IlvBN Operon of Escherichia coli K-12", Doctoral
Dissertation Department of Biology, Purdue University, West Lafayette, IN.
Kroyer,J.M.,J.B.Perkins,M.S.Rudinski,and D.H.Dean. (1980) "Physical mapping of Bacillus subtilis
cloning vehicles: Heteroduplex and restriction enzyme analysis" Molecular and General Genetics 177: 411-471.
Rudinski,M.S. and D.H.Dean.(1979)"Evolutionary considerations of related Bacillus subtilis temperate phages
                      rho6 as revealed by heteroduplex analysis" Virology 99: 57-69.
Dean,D.H.,J.B.Perkins,J.M.Kroyer,M.S.Rudinski, I.B Lazdins, P.A.Martin,W.F.Martin and F.R.Perro.(1979) "Phi do
phages: Helper independent temperate phage molecular cloning vehicles for Bacillus subtilis" Recombinant DNA
Technical Bulletin 2: 9-14.
Rudinski, M.S.(1978)"Heteroduplex analysis and genome structure of Bacillus subtilis temperate phages" Master's
thesis Department of Microbiology, The Ohio State University, Columbus, OH.

Modulation of Endothelin-1(ET-1), Endothelin Receptor Subtypes (ETA and ETB) and C-FOS Protooncogene
mRNA's in Early Ischemic Acute Renal Failure(IARF) in Rats. Madhu Chintala and Mark S. Rudinski. The American
Society of Nephrology, 26th Annual Meeting November 14-17 1993.
Hwa,J.J., Ghibaudi,L., Davis,H., Rudinski,M.S., & Strader,C. Effects of Melanocortin Receptor Agonist (MT-ll) on Food
Intake and body Weight Regulation in Obese and Lean Rats. Pennington Symposia on Obesity, March 29-31, 1998.
Abstract at Neuroscience National Meeting co-author-Glucose Responsive Neurons Are Potential Energy
Homeostasis Regulators. Ambrose Dunn-Meynell Neuroscience Abstracts 1998

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