Clinical Research Assistant

Profile:

A highly motivated, goal-oriented scientific leader with 15 years’ experience in engaging, leading, and managing Pre-clinical, Translational, Phase I, Phase II and Phase III Clinical Trials (Solid Tumor and Hematology- NCT04284228, NCT04505813, NCT00075764) as a Clinical Biomarker Expert/Clinical Research Scientist.

Expertise Includes:

oManaging and leading clinical research especially in areas like CAR-T cell therapy (CD19-CAR and CD33-CAR-preclinical and translational cancer biomarkers development), T-cell therapy (AML, MM, and HPV) for preclinical, translational, and clinical cancer biomarkers development.

oIND submissions, IRB submissions, ICFs, IBs and SUSAR submissions, Patient data monitoring and analysis, Clinical protocol development, Lab manual and Pharmacy manual review.

oDesign and implementation of preclinical, translational, and clinical biomarker studies, and advancing laboratory discoveries into early and late oncology clinical trials.

oDemonstrated ability to integrate the Immuno-oncology, translational biomarker discovery, T cell therapy knowledge, and regulatory expectations into the program strategy.

oExperience in preparing deliverables, progress reports and presenting preclinical translational and clinical data in periodic investigator meetings and scientific board/stakeholder meetings.

oLeading preclinical R&D level protein process development, scale up and technical support for manufacturing of proteins.

oHighly organized team player with a strong commitment to integrity and ability to consistently generate reliable data, while inspiring enthusiasm among colleagues and direct reports.

oProven ability to adapt and function collaboratively with cross-functional teams in a fast-paced matrix environment.

oExcellent oral and written communication skills and ability to facilitate idea exchange, prospectively identify project risks, and orchestrate plans to mitigate risks.

Associate Director/ Clinical Research - NexImmune (2017-present)

Key Responsibilities:

oLeading Preclinical, Traslational, Phase I and Phase II clinical trials - T-cell therapy, Cancer biomarkers development, IND submissions, IRB submissions, ICFs, IBs and SUSAR submissions, Patient data monitoring and analysis, Clinical protocol development, Lab manual and Pharmacy manual review.

oDevelop a data analysis platform and improvement vision for the use of Clinical, Phenotypic, Genetics and Bioinformatics methods in identifying signature biomarkers which can predict T cell therapy benefits/ adverse side effects.

oDesign internal workflows. Manage the biostatistician, bioinformatician and scientists to perform quick and thorough PK&PD analyses using Clinical, Phenotypic, Genetics, Proteomic, Transcriptomic and TCR immune seq. data to understand confounders. Make descriptive figures and address key scientific questions.

oCollaborate with clinical site/ CROs data scientists and computational biologists to align effective areas of focus.

oManage workstreams with external collaborations and alliances (Developing Legal contract, SOW, PO, shipping, billing data tracking).

oDevelop and maintain integrated project plans (internal program trackers, project timeline tracker and databases) to identify/communicate interdependencies as well as critical path activities across multiple programs.

oEffectively communicate with team members, senior leaders and key stakeholders on the status, objectives, risks, and mitigation plans associated with the various R&D projects, as well as ensure teams are aware of current integrated program timelines.

oFacilitate project team meetings using meeting management best practices to drive cross-functional communication, timely and effective decision making, and successful execution of objectives.

oCollaborate with the QC team to develop Standard Operating Procedures, quality, and regulatory requirements such as FDA/IND compliance.

oLead the R&D level protein process development, scale up and technical support for manufacturing of proteins, including management of 3 direct report.

oManage workflows with external collaborators until completion of the study.

oLead the study and demonstrate proficiency in various analytical methods to determine protein physico-chemical properties (PK&PD), activity, identity, stability, purity, Method/assay validation (Accuracy, Precision, Repeatability, Specificity, Linearity, Range, Detection Limit and Quantitation Limit) in support of R&D process development.

oLead the Optimization processes to ensure consistent, high-yielding, and scalable method to generate materials for pre-clinical studies.

oGenerate, manage, review, and maintain critical data, providing reports for assessments by senior management.

oCommunicate with various departments; Pre-clinical, Clinical, Process Development, Analytical, Manufacturing and QA/QC.

oKnowledge on Standard Operating Procedures, quality, and regulatory requirements such as FDA compliance.

Scientist/CAR T – Clinical biomarker specialist - Intrexon Corp. (December 2014- 2017) Immuno-Oncology Division, Intrexon.

Selected Accomplishments:

oDeveloping biomarkers data analysis platform for novel site directed drug delivery system using nanoparticles, which will have advantages over current drug delivery system.

oIdentify the signature biomarkers associated to CAR T- cell modification for advanced cancer therapy.

Research Assistant Professor-Central-lab- AstraZeneca and Southwest west oncology phase III breast cancer clinical trial (NCT00075764)- small molecule signature biomarker – data analysis pipeline development and data interpretation in collaboration with Department of Medical Genetics, University of Arkansas for Medical Science, Little Rock, Arkansas. (January 2007 to June 2014)

Selected Accomplishments:

oSignature biomarkers associated with AstraZeneca clinical trial partnered with Southwest Oncology Group to analyze and resolve an obstacle to clinical trials Fulvestrant up regulates UGT1A4 and MRP s through ERα and c-Myb pathways: a possible primary drug disposition mechanism for Anastrazole (UGT1A4 substrate) in anastrozole and fulvestrant co-treatment.

oDiscovery subsequently implemented in all fulvestrant clinical trials and prompted the development of more than 10 peer-reviewed publications.

EDUCATION

PhD in Human Genetics Human Genome Project Graduated 2003 IIT Roorkee, INDIA

Masters in Microbiology 94-96 Central University India

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