Nandagopal “Venkat” Prasad Ph.D., MBA

Houston, TX 281-***-**** addwg6@r.postjobfree.com

linkedin.com/in/venkat-prasad-phd-mba-640b4312

Clinical Research Scientist

Dynamic, forward-thinking leader with 25+ years of experience in clinical trials and clinical & pre-clinical drug discovery research

To develop a strong organizational team and to establish programs and policies in a patient centric, sponsor supportive environment. To lead people during periods of unplanned demands by strategic thinking, creating and executing strategies with effective communication. Passion for building strong teams with demonstrated ability to motivate and guide teams of 40+ onshore and offshore reports.

Highlights of Expertise

Strategic Planning & Execution

15+ years of CRO experience in Phase I-VI

15+ yrs Strategic Alliance & FSP experience

Cross-functional Team Leadership

Domestic & international (EU/APAC) work experience

Project Management exp: 10 years

505(b)(2), ANDA, & NDA Applications

ICH & GCP Guidelines FDA, MHRA, EMA, PMDA

Onsite & Remote work experience

TA: oncology, neuroscience, cardiovascular, pain, immunology, auto-immunity, vaccinology, and infectious diseases

Resource, Timeline & Budget Management

Creative Problem Solving & Disrupting Status Quo

Statistical Programming & Biostatistics

Medical Device & Diagnostic Research (MDDR)

Protocol, ICF, IRB, Submission, Data lock and CSR experience

Adv Analytics, Data Science, Statistical Thinking & Problem Solving

Clinical Data Standards (CDISC) & CDASH implementation

Eli Lilly-neuroscience & Pfizer-oncology: 4 years

Experienced Principal Investigator (Ovarian cancer – 4 years)

Career Experience

People Leader, 10 years of experience in Clinical Trials domain:

Mar 2010 – present Assoc Director, Scientific Affairs (Biostatistics & Programming)

Novum PRS, Pittsburgh, PA (Feb 2018- Mar 2020)

Manager, Statistical Programming Lead Stats Analyst

ICON plc, PA PPD InVentiv Health, Austin, TX (Mar 2010-Dec 2017)

Significantly contribute to execution of organizational strategies by skillfully leading day-to-day operations, ensuring alignment with regulatory guidelines, and driving process standardization, automation, and improvement while leading multidisciplinary team. Consistently delivered high-quality statistical products within demanding timelines and budgets while balancing multiple priorities across portfolio of 50+ clients with 100’s of deliverables.

Provided hands-on leadership for ED50, multi-dose, pilot, pilot-fasted & fed, pivotal, and pivotal fasted and fed pharmacokinetics studies

Implemented Global Team Resourcing Model to optimize limited resources and ensure timely execution of high-quality clinical trials

Examined demand vs. allocation for deliverables, produced global pricing tool, and enabled reporting of key performance indicators (KPI)

Orchestrated 505(b)(2), ANDA, and NDA submissions, ensuring accuracy and completeness.

Hired, promoted, mentored, and trained top performers onshore team and oversight of EU/APAC teams to align workflow with budget and timeline requirements

Evaluated current processes and update knowledge of compliance requirements, continuously introducing updated policies and procedures for data handling, quality assurance of deliverables

Served as liaison and expert resource during sponsor meetings and audits (including FDA, MHRA, PMDA, and EMA)

Collaborated with Quality Assurance (QA) team to ensure alignment with audit requirements and address deficiencies issued by FDA

Significantly contributed to achievement of revenue (~ $4 Mil) with 51% profit margin, increased collective utilization of team up to 96% within a short period from taking in-charge

Individual Contributor, 10 years of experience in Clinical Trials domain:

(Apr 2001 – Jan 2010) SAS Programmer Consultant

Comsys IT Partners (client-Pfizer), PRA International (multiple clients), AGI Staffing (Client-Bristol-Myers Squibb) 10/2006 – 01/2010

Clinical Principal Investigator Supra Biotech, Cofounder-Director Asst. Professor

The University of Texas Southwestern Medical Center at Dallas & Health Science Center at Houston, Supra biotech at Dallas, TX 4/2001 – 02/2006

Consistently delivered high-quality statistical products within demanding timelines and budgets while balancing multiple priorities across portfolio of 20+ clients with nearly 100 deliverables, optimizing limited resources

Developed timelines and coordinated statistical project management activities for several studies, ensuring proper prioritization of analyses by liaising with Computational Statisticians

Managed data locks for multiple high-priority Eli Lilly neuroscience studies

Spearheaded Phase I immunotherapy trial in gynecologic oncology/ovarian cancer using autologous dendritic cells

Prepared informed consent for protocols review with Institutional Review Board (IRB) and NIH grant administration

Collaborated with IRBs of several hospitals & Academic institutions in Dallas, Houston, Texas (MD Anderson, Cancer Center) for approved informed consent forms, clinical protocol

Conducted QOL interviews for the Infant Health and Development Program, Phase IV, 2001-2004

Individual Contributor Research Scientist – 8+ years of experience in Drug Discovery Research

(Jul 1990 - Dec 1998) Post – doctoral Research Scientist

The University of Texas Health Science Center at San Antonio, TX (11/1997 – 12/1998)

Medical Council Research, TB Unit Peptech Inc, London, UK (10/1993 – 11/1997)

Case Western Reserve University Cleveland Clinic, Cleveland, OH, (07/1990 - 08/1993)

Expertise in anti-inflammatory and anti-microbial drug discovery and development Expertise in molecular microbiology, biochemistry, immunology of infectious diseases

Designed, developed and executed pre-clinical human and animal model research projects Generated and analyzed pre-clinical data from human and animal model studies Interpreted data, written manuscripts and published data in the leading scientific journals

Investigated the biological characteristics of trehalose dimycolate (TDM - surface lipid) as a virulence factor from several clinical isolates of Myocbacterium tuberculosis (M. tb) using molecular, microbiological, and biochemical (TLS, GC-HPLC) methods

Several modes of delivery of Mycobacterial antigens on micorparticles or naked DNA / recombinant Vaccinia virus were developed and tested as potential vaccine delivery agents in a mouse model TB infection

Similarly prostaglandins induction modulates several cytokines expression in human blood monocytes infection M. avium complex clinical isolates from AIDS patients

Extra-mural Operational Leader & Entrepreneurial experience:

-7 years – Biweekly, monthly, quarterly operational meetings & discussions with Senior Management

-5 years – Board of Directors (Supra Biotech startup) (~3900 voluntary hours Jan 2000- Dec 2005)

-2 years – Board of Directors - Math tutoring company (weekend tutoring program – for a profit organization cofounded with a group of friends) (~200 voluntary hours)

-3 years - a community leader for a non-profit organization Sunday School (~350 voluntary hours)

Education & Credentials

Master of Business Administration (MBA), Information Technology (& Project) management

Western Governors University – Texas, Austin, TX

Patient-Oriented Clinical Research (Principal Investigator) Two-Year Program

-Biostatistics, Epidemiology & Survey Methods, Adv Methods

The University of Texas Southwestern Medical Center, Dallas, TX

Ph.D., Immunology & Biochemistry Master of Science, Biochemistry Bachelor of Science, Botany

The University of Madres, Chennai, Tamil Nadu, India

Leadership Development

Directors Leadership Workshop (Corporate & Departmental Initiatives), Novum PRS, Pittsburgh, PA

B&P Culture Workshop (Culture Assessments), ICON, North Wales, PA

LEAD Certification (Leadership Essentials), PPD, Wilmington, NC

People management & Emotional Quotient (EQ), InVentiv Health Intnl Pharma Services, Hyderabad, India

Professional Development Certifications

FDA – BIMO COVID-19 Update, Clinical Trial Requirements, Regulations, Compliance & GCP Conference

Developing Vaccines for COVID-19 – DIA

COVID-19 Pandemic and Clinical Data Management - Live Webinar by SCDM: Data Driven

CDISC 360 – Enterprise Architecture, Study Design & configuration, Automation of STD - CDISC

Advanced Analytics, JMP, SAS Academy of Data Science: Webinar by SAS Institute

Clinical Project Management - Certificate, Drug Information Association, Horsham, PA

Affiliations

Wcg Center Watch – Clinical Trials Professional Resources, 2020

Pharmaceutical User Software Exchange (PhUse), 2014

Clinical Data Interchange Standards Consortium (CDISC), 2013

Drug Information Association (DIA), 2008

Societies: Clinical Research Associates (SoCRA) Clinical Data Management (SCDM), 2006

Contact this candidate