Summary
Overview
Work History
Education
Skills
Personal Information
Affiliations
SELECT CLINICAL PRESENTATIONS
Timeline
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RAJIV RAJA

Summary

Translational and precision medicine leader focused on oncology clinical development, biomarker strategy, and diagnostic assay implementation. Directs companion diagnostic and ctDNA programs across late-stage NSCLC, SCLC, and HNSCC. Drives immunotherapy and ADC development through cross-functional execution and KOL-led scientific collaboration.

Overview

30
30
years of professional experience

Work History

Executive Director, Translational Medicine Lead | Clinical Biomarkers & Correlative Sciences, Oncology Translational Medicine

GLAXOSMITHKLINE
01.2022 - Current
  • June 2023–June 2024: Led biomarker strategy and implementation for early/1L metastatic NSCLC and locally advanced/metastatic HNSCC programs in immunotherapy.
  • July 2024—present: Led biomarker strategy and implementation for advanced/metastatic NSCLC, SCLC, and HNSCC trials, enhancing precision in antibody-drug conjugate (ADC) programs.
  • May 2022—present: Developed circulating tumor DNA (ctDNA) strategy for oncology development at GSK, advancing biomarker integration in clinical research.
  • May 2022—present: Directed strategy for 3D organoid model development in solid tumors, supporting innovative approaches in oncology research at GSK.

Senior Director, Precision Medicine Lead (sabbatical) | Precision Medicine Oncology

ASTRAZENECA
01.2021 - 01.2022
  • Developed and implemented CDx strategy for DESTINY Lung-04, a Phase III randomized registrational study for evaluating the efficacy of trastuzumab deruxtecan (Enhertu) in 1st line HER2 mutant NSCLC.
  • Implemented NGS-based CDx-ready ctDNA assay for prospective selection of HER2 mutant NSCLC patients globally, including China.
  • Developed CDx plan for HER2 mutation detection in NSCLC targeting global markets and specifically addressing needs in China.

Senior Director/Director, Translational Medicine Lead | Head of Translational Genomics Labs | Translational Medicine Oncology

MEDIMMUNE/ASTRAZENECA
01.2015 - 01.2021
  • Translational medicine lead for late-stage lung cancer immunotherapy programs (over 25 clinical trials). Led the development and implementation of translational medicine strategies for neoadjuvant, adjuvant and 1L metastatic NSCLC registration trials. Supervised 3 translational medicine lead.
  • Collaborated with Guardant Health to develop blood-based tumor mutational burden (bTMB) assay for multiple indications, contributing to its validation as predictive of response to durvalumab and durvalumab + tremelimumab therapies in MYSTIC and NEPTUNE Phase III trials.
  • Developed ctDNA-based molecular response (MR), tumor mutational burden (bTMB), and minimal residual disease (MRD) assays for early-stage lung, HNSCC, and bladder cancers in collaboration with industry leaders Natera, ArcherDx, Guardant Health, Foundation Medicine, Resolution Biosciences, and GRAIL, enhancing diagnostic capabilities.
  • Led discussions with the scientific advisory board, clinicians, and key opinion leaders on evolving biomarker landscape in lung cancer, influencing treatment paradigms and addressing challenges in biomarker testing implementation.
  • Head of the genomics group that developed and implemented cutting-edge technologies such as high-sensitivity RNAseq, single-cell RNAseq and CITE-Seq to perform biomarker assessments across various therapeutic areas at AstraZeneca (Wang et al. 2019). Managed 10 translational genomics scientists and associates.

Translational Medicine Lead, Oncology Biomarker Development | Group Leader, Clinical Assays and Technologies

GENENTECH/ROCHE
01.2007 - 01.2015
  • Translational medicine lead for antibody-drug conjugates (ADC) in Phase I development. Developed and implemented biomarker strategy for ADC programs; performed biomarker studies to inform indication selection, evaluate mechanisms of action and target engagement; worked closely with CDx experts, Ventana and Roche Molecular Diagnostics to develop CDx assays.
  • Developed molecular CDx assays and evaluated next-generation CDx technologies with partners Roche Molecular Diagnostics, Foundation Medicine, and Ventana. Collaborated with external partners to create CDx assays for biomarker analysis of clinical trial samples; implemented novel high-throughput technologies including Fluidigm, Nanostring, WES, targeted mutation panels, and RNAseq for molecular analysis of challenging clinical samples.
  • Implemented diagnostic assays to assess minimal residual disease (MRD) in hematological malignancies using ASO-PCR and NGS. Led the assessment of MRD as a primary end-point for the Venetoclax Phase III study in CLL; worked closely with investigator labs and CROs to implement an ASO-PCR test for the clinic; performed orthogonal validation using a prototype version of ClonoSEQ (Adaptive Biotechnologies); conducted validation studies required for the submission of an analytical validation report (AVR) for CDRH.
  • Evaluated and implemented technology platforms for circulating tumor DNA (ctDNA) and circulating tumor cell (CTC) analysis in clinical trial samples. Implemented Biomark microfluidic system for ctDNA analysis; evaluated CellSearch, EPIC, MagSweeper, and UltraView systems for CTC analysis; performed enumeration and analysis of cell surface markers in CTCs across 8000 samples from over 20 oncology clinical trials.
  • Led a team of 20 professionals conducting biomarker analysis for clinical trial samples.

Director/Senior Scientist, Molecular Biology R&D

MOLECULAR DEVICES / ARCTURUS BIOSCIENCE
01.2000 - 01.2007
  • Directed a molecular biology R&D team of 12 scientists to develop molecular biology kits and reagents. Developed and launched six molecular biology products. Generated comprehensive developmental plans and timelines. Managed cross-functional teams from product feasibility to launch. These products currently marketed by Thermo Fisher Scientific helped establish a market leader position for Arcturus in high-throughput gene expression analysis tools.
  • Developed and implemented molecular diagnostic tests for breast cancer recurrence and cancer of unknown primary (CUP, Ma et al. 2006) based on QRT-PCR and microarrays. Current versions of these tests are offered as LDTs under brand names MammaPrint and Cancer TYPE ID respectively. Instructed laboratory technicians at reference laboratories on validating and implementing these diagnostic tests.
  • Implemented GMP-compliant procedures enabling the development of high-quality diagnostic products. Wrote SOPs under QSR, including management control, document control, process control, and CAPA. Trained manufacturing and QC personnel during product transfers.
  • Led collaborative study with California Institute of Regenerative Medicine (CIRM) at Stanford University. Developed assays for gene expression profiling of single embryonic cells using microfluidic-chip-based technology. Co-authored landmark publication on global gene expression profiling of single oocytes and embryos during early human development (Dobson et al. 2004). Completed proof-of-concept studies using real-time imaging to predict maturation of human embryos to the blastocyst stage, improving the success rate of in-vitro fertilization (IVF).
  • Established external collaborations with key opinion leaders and companies for product development projects, resulting in publications. Validated microgenomics technology for oncology and developmental biology.

Biomedical Scientist

LAWRENCE LIVERMORE NATIONAL LAB / UCSF
01.1998 - 01.2000
  • Investigated gene expression changes in oocytes and embryos at early developmental stages, identifying differentially expressed genes during human embryo development.
  • Processed biospecimens and prepared samples for cellular and molecular analysis.
  • Conducted biomedical research using LLNL and UCSF laboratory protocols.
  • Maintained sterile cell culture conditions and monitored laboratory equipment.

Post-doctoral Fellow

UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN
01.1997 - 01.1998
  • Analyzed Quantitative Trait Loci (QTL) and conducted linkage analysis using RAPD, AFLP, and SSR markers to identify genetic variations.
  • Designed experiments and analyzed data using statistical and visualization tools.
  • Conducted interdisciplinary research in Illinois campus laboratories and collaborative centers.
  • Reviewed scholarly literature to refine hypotheses and research methods.

Education

Doctor of Philosophy (Ph.D.) - Molecular Genetics / Genomics

Oklahoma State University
Stillwater, Oklahoma

Master of Science (M.S.) - Natural Resources Management

University of Idaho
Moscow, Idaho

Bachelor of Science (B.S.) -

Kerala Agricultural University
Kerala, India

Skills

  • Biomarker strategy and companion diagnostics
  • Clinical assay development
  • ctDNA analysis
  • Translational genomics
  • Oncology trial design
  • Cross-functional leadership
  • Clinical research operations
  • Scientific communication
  • Team leadership and staff management
  • Strategic planning
  • Strategic planning
  • Staff management

Personal Information

Title: Executive Scientific Leader | Translational Medicine | Oncology & Precision Medicine

Affiliations

  • Professional affiliations reflecting continued engagement with translational science, oncology research and biomedical innovation.
  • California Institute of Regenerative Medicine (CIRM) — Grants Working Group (GWG)
  • Scientific service affiliation within CIRM's Grants Working Group, complementing Rajiv's background in translational research, molecular diagnostics and biomedical assay development.
  • American Society of Clinical Oncology (ASCO)
  • Professional membership aligned with Rajiv's extensive oncology translational medicine, biomarker-development and clinical research experience.

SELECT CLINICAL PRESENTATIONS

  • Peters S, Rizvi NA, Kuziora M, Lai Z, Shrestha Y, Dey A, Barrett JC, Scheuring U, Poole L, Abbosh C, Raja R, Hellmann M. 2021. Early circulating tumour DNA (ctDNA) dynamics for predicting and monitoring response to immunotherapy(LO) vs chemotherapy (CT) in patients with 1L metastatic (m) NSCLC: analyses from the Phase 3 MYSTIC trial. Presentation at ESMO, September 2021. (Web link)
  • Wildsmith S,Walker J, L'Hernault A, Li W, Bye H, He P, Xiao M, Zhang Q, Stewart R, de los Reyes M, Raja R, Levin W, Gupta A, Powles T, Bellmunt J, Galsky MD, Drakaki A, and van der Heijden M. 2020. Tumor mutation burden (TMB) and efficacy outcomes in the phase III DANUBE study of advanced urothelial carcinoma. Presentation at SITC, November 2020 (Web link).
  • Li W, Wildsmith S, Ye J, Si H, Morsli N, He P, Shetty J, Yovine A, Holoweczkyj N, Raja R, Real K, Scorer P, Hembrough T, Walker J, Zhang Q, Xie M, Mesia R, Haddad R, Licitra L, and Ferris RL. 2020. Plasma-based Tumor Mutational Burden as Predictor for Survival in Phase III EAGLE Study: Durvalumab ± Tremelimumab Versus Chemotherapy in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma After Platinum Failure. Presentation at ASCO, May 2020 (Web link).
  • Rizvi NA, Cho BC, Reinhuth N, Lee KH, Luft A, Ahn MJ, Heuvel M, Dols MC, Vicente D, Smolin A, Moiseyenko V, Antonia SJ, Nakagawa K, Goldberg SB, Kim ES, Walker J, Raja R, Liu F, Scheuring UJ and Peters S. 2019. Blood tumor mutational burden (bTMB) and tumor PD-L1 as predictive biomarkers of survival in MYSTIC: First-line durvalumab (D) ± tremelimumab (T) versus chemotherapy (CT) in metastatic (m) NSCLC. Journal of Clinical Oncology 37:15_suppl, 9016 (Web Link)
  • Peters S, Cho BC, Reinhuth N, Lee KH, Luft A, Ahn MJ, Baas P, Dols MC, Smolin A, Vicente D, Moiseyenko V, Antonia SJ, Nakagawa K, Goldberg SB, Kim ES, Raja R, Brohawn P, Clemett D, Thiyyarajah P, Scheuring U, Liu F and Rizvi N. 2019. Tumor mutational burden (TMB) as a biomarker of survival in metastatic non-small cell lung cancer (mNSCLC): Blood and tissue TMB analysis from MYSTIC, a Phase III study of first-line durvalumab ± tremelimumab vs chemotherapy. Cancer Res 79:13 suppl, CT074. (Web Link)
  • Si H, Kuziora M, Helman E, Quinn K, Brohawn PZ, Scheuring U, Peters S, Rizvi N, Raja R, Ranade K and Higgs BW. 2019. A blood-based assay for assessment of tumor mutational burden in patients with metastatic NSCLC in the first-line treatment setting: results from the MYSTIC study. Eur J Cancer Volume 110, S2. (Web Link)
  • (Full list available on request)
  • McCoon P, Wang Y, Lai Z, Zhang Q, Li W, Wildsmith S, Morsli N, Raja R, Holoweczkyj N, Walker J, de los Reyes M, Mesia R, Licitra L, Ferris R, Fayette J, Zandberg D, Siu L and Haddad R. M. 2025. Mutational landscape of recurrent/metastatic head and neck squamous cell carcinoma and association with immune checkpoint inhibitor outcome. Clin. Cancer Res. 31(10): 1931-42 (Web Link)
  • Castro Jr G,Rizvi NA, Schmid P, Syrigos K, Martin C, Yamamoto N, Cheng Y, Moiseyenko V, Summers Y, Vynnychenko I, Lee YS, Maciej B, Zer A, Erman M, Timcheva C, Raja R, Naicker K, Scheuring U, Walker J, Mann H, Chand V, and Mok T. 2023. NEPTUNE: Phase 3 study of first-line durvalumab plus tremelimumab in patients with metastatic non-small cell lung cancer. J Thorac. Oncol. 18(11): 106-119 (Web Link)
  • Luo J, Wu S, Rizvi H, Zhang Q, Egger JV, Osorio J, Schoenfeld AJ, Piodkowski AJ, Ginsberg MS, Callahan MK, Maher C, Shoushtari AN, Postow MA, Voss MH, Kotecha RR, Gupta A, Raja R, Kris MG and Hellmann MD. 2022. Deciphering radiological stable disease to immune checkpoint inhibitors. Ann. Oncol. (Web Link)
  • Pore N, Wu S, Kunkel MJ, Morehouse C, Shrestha Y, de los Reyes M, Halpin R, RothsteinR , Mulgrew K, Blackmore S, Martin P, Meekin J, Proia T, Herbst R, Raja R, Ascierto ML and OberstM. 2021. Resistance to durvalumab and durvalumab plus tremelimumab is associated with functional STK11 mutations in non-small-cell lung cancer patients and is reversed by STAT3 knockdown. Cancer Discov. 11:1-18 (Web Link)
  • Si H, Kuziora M, Quinn K, Helman E, Ye J, Scheuring U, Peters S, Rizvi N, Brohawn P, Ranade K, Higgs BW, Bans KC, and Raja, R. 2021. A blood-based assay for assessment of tumour mutational burden in patients with metastatic NSCLC in the first-line treatment setting: results from the MYSTIC study. Clin. Cancer Res. 27: 1631-40. (Web Link)
  • Rizvi NA, Cho BC, Reinhuth N, Lee KH, Luft A, Ahn MJ, Heuvel MM, Cobo M, Vicente D, Smolin A, Moiseyenko V, Antonia SJ, Moullec SL, Robinet G, Natale R, Schneider J, Shepherd FA, Geater SL, Garon EB, Kim ES, Goldberg SB, Nakagawa K, Raja R, Higgs BW, Boothman A, Zhao L, Scheuring U, Stockman PK, Chand VK and Peters S. 2020. Durvalumab With or Without Tremelimumab vs Standard Chemotherapy in First-line Treatment of Metastatic Non-Small-Cell Lung Cancer: The MYSTIC Phase 3 Randomized Clinical Trial. JAMA Oncology. 6(5):661-674 (Web Link)
  • Dagher R, Copenhagen AM, Besnard V, Berlin A, Hamidi F, Marett M, Wang J, Qu X, Shrestha Y, Wu J, Gautier G, Raja R, Aubier M, Kolbeck R, Humbles AA and Pretolani M. 2020. IL-33-ST2 axis regulates myeloid cell differentiation and activation enabling effective club cell regeneration. Nat. Commun. 11, 4786. (Web Link)
  • Wang J, Rieder SA, Wu J, Hayes S, Halpin RA, de Los Reyes M, Shrestha Y, Kolbeck R, Raja R. 2019. Evaluation of ultra-low input RNA sequencing for the study of human T cell transcriptome Sci. Rep. 9(1): 8445. (Web Link)
  • Raja R, Kuziora M, Brohawn PZ, Higgs BW, Antal J, Gupta A, Dennis P and Ranade K. 2018. Early Reduction in Circulating Tumor DNA Predicts Survival in Non-Small Cell Lung Cancer and Urothelial Bladder Cancer Patients Treated with Durvalumab. Clin. Cancer Res. 24 (24): 6212-6222 (Web Link)
  • Schleifman EB, Tam R, Patel R, Tsan A, Sumiyoshi T, Fu L, Desai R, Schoenbrunner N, Myers T, Bauer K, Smith E and Raja R. 2014. Next Generation MUT-MAP, a High-Sensitivity High-Throughput Microfluidics Chip-Based Mutation Analysis Panel. PLoS One 9(3): e90761 (Web Link)
  • Shames DS, Carbon J, Walter K, Jubb AM, Kozlowski C, Januario T, Do A, Fu L, Xiao Y, Raja R, Jiang B, Malekafzali A, Stern H, Settleman J, Wilson TR, Hampton GM, Yauch RL, Pirzkal A and Amier LC. 2013. High Hergulinn Expression Is Associated with Activated HER3 and May Define an Actionable Biomarker in Patients with Squamous Cell Carcinomas of the Head and Neck. PLoS One 8(2): e56765 (Web Link)
  • Punnoose EA, Atwal S, Liu W, Raja R, Fine BM, Hughes BG, Hicks RJ, Hampton GM, Amier LC, Pirzkal A and Lackner MR. 2012. Evaluation of Circulating Tumor Cells and Circulating Tumor DNA in Non-Small Cell Lung Cancer: Association with Clinical Endpoints in a Phase II Clinical Trial of Pertuzumab and Erlotinib. Clin Cancer Res. 18(8): OF1-11 (Web Link)
  • Ma X, Patel R, Salunga R, Wang X, Chu S, Raja R and Erlander M. 2006. Molecular Classification of Human Cancers using a 92-Gene Real-time Quantitative PCR Assay. Archives of Pathology & Laboratory Medicine. 130(4):465-473. (Web Link)
  • Dobson AT, Raja R, Abyeta MJ, Taylor TB, Shen S, Haqq C and Reijo RP. 2004. The unique transcriptome through day 3 of human preimplantation development. Human Molecular Genetics. 13(14):1461-1470. (Web Link)

Timeline

Executive Director, Translational Medicine Lead | Clinical Biomarkers & Correlative Sciences, Oncology Translational Medicine

GLAXOSMITHKLINE
01.2022 - Current

Senior Director, Precision Medicine Lead (sabbatical) | Precision Medicine Oncology

ASTRAZENECA
01.2021 - 01.2022

Senior Director/Director, Translational Medicine Lead | Head of Translational Genomics Labs | Translational Medicine Oncology

MEDIMMUNE/ASTRAZENECA
01.2015 - 01.2021

Translational Medicine Lead, Oncology Biomarker Development | Group Leader, Clinical Assays and Technologies

GENENTECH/ROCHE
01.2007 - 01.2015

Director/Senior Scientist, Molecular Biology R&D

MOLECULAR DEVICES / ARCTURUS BIOSCIENCE
01.2000 - 01.2007

Biomedical Scientist

LAWRENCE LIVERMORE NATIONAL LAB / UCSF
01.1998 - 01.2000

Post-doctoral Fellow

UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN
01.1997 - 01.1998

Doctor of Philosophy (Ph.D.) - Molecular Genetics / Genomics

Oklahoma State University

Master of Science (M.S.) - Natural Resources Management

University of Idaho

Bachelor of Science (B.S.) -

Kerala Agricultural University
RAJIV RAJA