Nitya Maddodi

**** #* ***** ***** **. Highlands Ranch, CO 80130

Email: ac1nb5@r.postjobfree.com

Phone: 608-***-****

Project manager/ Scientist with the ability to design and develop a strategic vision to execute product development and clinical research project management in drug and device development. Experience of 10 years, working on clinical and preclinical research projects in the R&D, creating new technology and strategy development across medical clinical research, regulations and medical affairs. Strong ability to align cross-functional teams of Scientists, IT, and Clinicians for implementation of clinical research projects. Strong knowledge in operations and supply chain management. Responsibilities involve communicating business benefits of product development and implementations to senior decision makers. Manage day to day activity with extensive project management skills, writing protocols for IRB approval, and strong training and mentoring experience.

Core Competencies

Project Management

Clinical research

Mentoring and Training

Communication Skills

Business Operation

Policy and Regulation

Business Strategy

Product Development

R&D Medical Research

Product development skills:

Strategized and implemented early stage clinical products (miRNA as biomarkers for patients with melanoma skin cancer). Responsibility included managing cross functional teams for early discovery, preclinical R&D, clinical data collection and biostatical data analysis

Coordinated with development teams for new products integration which are in pipeline for clinical implementation in children with ectodermal dysplasia

Validated clinical cell therapy products, provided resources for new product development and regulatory submission to federal agencies

Implemented preclinical studies for validation of new medical device to detect circulating tumor cells

Project management skills:

Developed and managed research projects to evaluate clinical application of new electrochemical immunosensing medical device for detecting circulating tumor cells in cancer patients

Completed seven clinical research projects in dermatology and oncology:

Chemotherapy drug development project for cancer therapy

Biomarker development project in melanoma patients

Stem cell therapy clinical research project

Medical device product development clinical research project

Handled project planning and implementation of investigational drug trials and ISR projects

Communication and Collaborators skills:

Published 19 scientific research articles in international journals and developed several SOPs

Presented research findings and products at more than 30 international meetings and seminars

Successful completed Investigator Sponsored Research project as a Principal Investigator

Managed seven Investigator Sponsored Research projects and federal grant applications

Collaborated with clinicians, scientists, techs in various projects, grants and research reports

Recruited and managed patients for federal sponsored clinical trials

Trained and mentored team members, technicians, scientists and graduate students

Business skills and computer knowledge:

As a MBA candidate at Leeds school of Business, developed the ability to generate business report, financial and developed the ability to build strong strategy and marketing plans

Strong knowledge to develop business operations and strategy in R&D product development

Experience in operations and supply chain management

Strong working knowledge in Microsoft, web-based application and presentation, and data analysis tools, data mining, bioinformatics and target profiling

Work Experience:

University of Colorado - Gates Center for Regenerative Medicine and Dermatology Dec 2014 – Aug 2016

Project Manager/ Scientist – Anschutz Medical Campus, Aurora, CO

Responsible for development of preclinical and clinical cell-based therapy products for skin disorders using Stem Cell technology. Managed research project operations and developed business strategy for developing new innovative products.

Executed research and financial plans to develop patient-derived pre-clinical cell-based therapy

Trained and mentored team members, technicians, undergraduate and graduate students

Managed day-to-day project requirements, including regulator, financial and logistical needs

University of Wisconsin – Department of Dermatology June 2010 – July 2014

Project manager (R&D)/ Scientist – School of Medicine and Public Health, Madison, WI

Responsibility expanded from previous role into Scientist to include project management and driving the development of new product for prognostic and diagnostic application in cancer patients

Executed operational activities for new product development and clinical application including clinical data collection and analysis. Discovered new melanoma prognostic biomarker for skin cancer melanoma progression

Initiated and executed clinical studies to validate biomarkers in melanoma patients and recruited 250 patients to validate clinical outcomes

Designed clinical studies and developed new medical device, electrochemical immunosensing device for detecting circulating tumor cells in cancer patients

Discovered tumor suppressor drugs for skin cancer. These information lead to development of potential drugs for cancer therapy

Established multiple cross-disciplinary collaborations across campus and abroad

Published first author (4) and co-author (5) papers and I was successful in obtaining ISR projects from Dermatology Foundation for 3 consecutive years to pursue my projects

University of Wisconsin – Department of Dermatology May 2005 – May 2009

Post-doctoral fellow – School of Medicine and Public Health, Madison, WI

Designed, conducted and analyzed projects to develop new BRAF kinase therapeutic agents to treat melanoma (which are in early phase of clinical trials)

Discovered Lupeol and Fisetin as chemo-preventive and anti-cancer drugs for prostrate and skin cancer. Established pre-clinical and clinical projects to evaluate the chemo-preventive and therapeutic efficacies of agents

Fostered collaborations on and off campus to learn new techniques and gain necessary resources and knowledge outside my field of study to further clinical research

Trained and mentored undergraduate students and PhD candidates in scientific experiments, written and oral communication skills, time management, and good general laboratory practices

Published first author (2) and co-author (4) research articles, presented scientific research articles in international meetings, scientific posters to academic, medical, and non-academic audiences

Manipal University – Department of Biotechnology Jan 2004 – April 2005

Assistant Professor – Kasturba Medical College, India

Designed clinical projects and analyzed effect of snake venom (Bothrops) on wound healing for development of clinical phase product. Project sponsored by Jaggat pharma, India.

Designed, conducted, and analyzed pharmacogentics projects for the identification of single nucleotide polymorphisms (SNPs) in folate metabolizing enzyme in South Indian population

Developed strategy for research projects, teaching and lecturing in Life Sciences for the undergraduate students, and assist in course development

Education:

Master in Business Administration (Operations & Project Management) May 2017

Leeds School of Business, University of Colorado-Boulder

Post-doctoral fellow June 2010

Dermatology, University of Wisconsin-Madison

Doctor of Philosophy May 2005

Biosciences (Life sciences), Mangalore University, India

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