Open To Work
Hi, I’m
Marc Roy
Non-Clinical Toxicologist
Arlington,MA
Summary
Results-oriented pre-clinical drug safety scientist with extensive experience in evaluating toxicity and efficacy across diverse modalities, including small molecules and gene therapy. Led scientific and regulatory strategy at the organizational level and authored key regulatory documents. Seeking Executive Director of Toxicology role to leverage investigative expertise and regulatory knowledge in advancing clinical drug development.
Overview
17
years of professional experience
Work History
Sarepta TherapeuticsCambridge, MA
Toxicologist - Nonclinical Safety
10.2024 - 07.2025
Job overview
- Nonclinical Safety Lead for SRP-9010 (AAV), and SRP-1001, and SRP-1003
- Authored preclinical safety sections of regulatory documents for SRP-9010, facilitating successful regulatory filing
- Reviewed pharmacology and toxicology reports from CROs, ensuring accurate interpretation of study results and timely finalization of main and sub-reports
- Defined preclinical development plans for each program, established timelines, and ensured adherence to execution deadlines
Strand TherapeuticsBoston, MA
Senior Director - Nonclinical Safety
06.2023 - 04.2024
Job overview
- Defined preclinical development plans for each program, established timelines, and ensured execution according to those timelines
- Designed and executed preclinical GLP and non-GLP studies using internal and external (CRO) resources to meet project objectives
- Authored preclinical safety sections of all regulatory documents for programs STX-001 regulatory filing support
- Reviewed pharmacology and toxicology reports from CROs for accuracy and authored sections of main and sub-reports.
- Authoring and reviewing all pharmacokinetic and toxicology related modules of STX-001 IND, and other regulatory documents (e.g. Investigators brochure)
- Successfully filed with FDA (USA) and TGA (Australia) for investigative drug applications and initiation of clinical trials (with no preclinical inquiries)
- Expanded internal research capabilities in pathology and DMPK groups to enhance overall research functionality
- Built internal histology, immunochemistry and in-situ hybridization resources
- Collaborated with Translational Biology to develop specific correlative endpoints for upcoming clinical trials.
- Nonclinical lead for STX-001, STX-003, STX-004, and STX-005 pre-clinical programs.
Design TherapeuticsCarlsbad, CA
Senior Director - Nonclinical Safety
05.2022 - 05.2023
Job overview
- Safety and pharmacology lead for DT-216, DT-168 and all pre-clinical programs.
- Successfully filed with FDA (USA) for investigative new drug application of DT-168 and initiation of clinical trials (with no preclinical inquiries)
- Authored and reviewed all pharmacokinetic and toxicology related modules of DT-216 and DT-168 IND, and other regulatory documents (e.g. Investigators brochure)
- Designed and executed preclinical GLP and non-GLP studies using internal and external (CRO) resources to meet program objectives
- Defined preclinical development plans for each program, established and monitored timelines to ensure on-time execution
- Reviewed and revised study reports for accuracy and regulatory compliance, ensuring alignment with industry standards.
Dyne TherapeuticsWaltham, MA
Senior Director - Preclinical Development
08.2021 - 05.2022
Job overview
- Successful clearance of IND for DYNE-251, with mitigation of clinical hold through efficient and timely completion of nonclinical studies supporting safety and pharmacology
- Defined preclinical development plans for each program, established timelines, and ensured execution according to those timelines
- Designed and executed preclinical GLP and non-GLP studies using internal and external (CRO) resources
- Authored preclinical safety sections of all regulatory documents for programs
- Developed investigative studies to enhance biological understanding of Dyne's delivery platform through design of in vitro and in vivo studies
- Represented preclinical efforts for DYNE-251 and DYNE-301, streamlining communication between teams.
- Preclinical representative for Force Platform expansion
- Supported development of next-generation delivery agents and new target validation
Novartis Institute of Biomedical ResearchCambridge, MA
Director - Preclinical Safety Project Team Lead
12.2020 - 08.2021
Job overview
- Authored preclinical safety sections of all regulatory documents for programs
- Defined preclinical development plans for programs, established and managed timelines to ensure on-time execution
- Designed and executed preclinical GLP and non-GLP studies by coordinating internal teams and external CRO resources
- Acted as the preclinical representative for all Sangamo Therapeutics collaborations and multiple CNS AAV programs across early and late-stage development.
Sarepta TherapeuticsCambridge, MA
Senior Director - Head of Nonclinical Safety
03.2020 - 11.2020
Job overview
- Accountable for nonclinical safety strategy, execution across portfolio, and managing budget of ~$25M/annually.
- Contributed to team addressing Vyondys53 CRL from FDA, leading successful appeal and subsequent approval.
- Authored and reviewed written responses to global regulatory inquiries on safety in nonclinical studies, ensuring compliance and clarity.
- Prepared and approved nonclinical sections of IND, NDA, investigator brochures, and briefing booklets, facilitating regulatory submissions.
- Represented Sarepta as nonclinical SME at all face-to-face interactions with regulatory agencies (FDA, EMA, PMDA)
PfizerGroton, Connecticut
Director – Investigative Toxicology
10.2017 - 01.2019
Job overview
- Defined scientific strategy for investigating platform-related toxicities, including gene therapy and nanoparticle delivery systems.
- Contributed to Global Investigative Toxicology Leadership Team, shaping scientific strategy and technology investments.
- Designed non-clinical investigative studies for assets in clinical development.
- Established next generation sequencing laboratory, automating NGS processes to improve data generation speed and operational efficiency.
- Developed NGS data storage and management strategy, leveraging global high-performance computing center for enhanced data accessibility.
- Established in-house single cell RNA sequencing capabilities with V(D)J profiling assays for gene therapy immune response analysis.
- Reviewed and endorsed all GLP and carcinogenicity study designs.
- Validated high-throughput whole transcriptome assays, increasing data throughput speed and optimizing profiling costs.
PfizerGroton, Connecticut
Global Molecular Pathology Lead
02.2017 - 10.2017
Job overview
- Oversaw Investigative Molecular Pathology Laboratory within DSRD, ensuring compliance with regulatory standards and enhancing operational efficiency.
- Defined optimal RNA sequencing methods for materials extracted from FFPE tissues, enabling mechanistic studies using archived samples.
- Utilized FFPE tissues for transcriptomic profiling, facilitating rapid data delivery and minimizing animal use.
- Represented Pfizer in HESI Genomics FFPE NGS working group, providing scientific guidance and support.
- Managed portfolio support across four research units: Neuroscience, Pain, Cardiovascular & Metabolic Diseases, and Oncology, aligning project goals with strategic research initiatives.
PfizerGroton, Connecticut
Principal/Senior Principal Scientist
05.2008 - 12.2011
Job overview
- Led molecular pathology for global Investigative Antibody Drug Conjugate team.
- Led development and validation of patient selection assays for ADC programs, authoring four LDT reports for FDA submission to support regulatory compliance.
- Developed in vitro models to predict organ damage and toxicity, minimizing exploratory ADC studies.
- Pioneered RNAscope assay application for automated slide staining, reducing time to assay validation.
- Designed characterization processes using western blot, qRT-PCR, ISH, and IHC for primary tumors.
- Characterized two oncology therapeutic targets in primary tumors, providing critical insights that informed program terminations.
- Managed Investigative Molecular Pathology Laboratory within Drug Safety Research and Development.
- Facilitated collaboration within practice network to improve operational efficiency. to enhance internal capabilities.
Education
Assumption CollegeWorcester, MA
B.A. from Chemistry
05-2001
Boston College Graduate School of Arts and ScienceBoston
Ph.D. from Chemical Biology
Skills
- RNA sequencing library preparation
- Quality assessment
- Purification
- Sequencing by synthesis
- Phage display technology
- Selection screening
- Fluorescence in situ hybridization
- Protein expression
- Protein isolation
- Protein purification
- Gene cloning
- Nucleic acid isolation
- Nucleic acid quality assessment
- RNA transcription
- SiRNA knockdown
- Antisense oligonucleotide design
- Target knock-down
- Mammalian cell culture
- PCR
- QRT-PCR
- Nanostring targeted sequencing
- Gel electrophoresis
- Western blot
- Northern blot
- Southern blot
- Sanger sequencing
- Quantum dot synthesis
- Solid phase peptide synthesis
- Solid phase oligonucleotide synthesis
- Thin-film radio frequency magnetron sputtering
- Quartz crystal microbalance - dissipation
- Surface plasmon resonance
- Liquid chromatography
- Spectroscopy
- Comet assay
- Radioisotope labeling
- Immunohistochemical protocols
- In situ hybridization protocols
- Confocal microscopy
- Spectral imaging
- Electron microscopy
- Image analysis
- Data visualization
- Statistics
- NGS data analysis
- Multiplex RNA expression analysis
- Qiagen Ingenuity Pathway Analysis
Publications
- NOTCH3-targeted Antibody Drug Conjugates Regress Tumors by Inducing Apoptosis in Receptor Cells and Through Transendocytosis into Ligand Cells, Geles, K.G., Gao, Y., Giannakou, A., Sridharan, L., Yamin, T., Zhang, J., Karim, R., Bard J., Piche-Nicholas, N., Charati, M., Maderna, A., Lucas, J., Goals, J., Guffroy, M., Pirie-Shepherd, S., Roy M., Qian J., Franks, T., Zhong, W., O'Donnell, C.J., Tchistiakova, L., Gerber, HP., Sapra, P., Cell Reports Medicine, 2021, 2, 5, 100279
- Expression of Hematopoietic Stem and Endothelial Cell Markers in Canine Hemangiosarcoma, Kakiuchi-Kiyota, S., Obert, L.A., Crowell, D.M., Xia, S., Roy, M.D., Coskran, T.M., Kreeger, J.M., Crabbs, T.A., Cohen, S.M., Cattley, R.C., Cook, J.C., Toxicologic Pathology, 2020, 48, 3, 481
- Myocarditis in Cynomolgus Monkeys Following Treatment with Immune Checkpoint Inhibitors, Ji, C., Roy, M.D., Golas, J. Vitsky, A. Kumpf, S.W., Martin, M., Barletta, F., Meier, W., Ram, S., Hooper, A., Sapra, P., Khan, N., Finkelstein, M., Guffroy, M., Beutow, B.S., Clinical Cancer Research, 2019, 25, 15, 4735
- Receptor-Mediated Delivery of CRISPR-Cas9 Endonuclease for Cell-Type-Specific Gene Editing, Rouet, R., Thuma, B.A., Roy, M.D., Lintner N.G., Rubitski, D.M., Finley, J.E., Wisniewska, H.M., Mendonsa, R., Hirsh, A., de Oñate, L., Compte Barrón, J., McLellan, T.J., Bellenger, J., Feng, X., Varghese, A., Chrunyk, B.A., Borzilleri, K., Hesp, K.D., Zhou, K., Ma, N., Tu, M., Dullea, R., McClure, K.F., Wilson, R.C., Liras, S., Mascitti, V., Doudna J.A., Journal of the American Chemical Society, 2018, 140, 21, 6596
- Α5 nAChR modulation of the prefrontal cortex makes attention resilient, Howe, W.M., Brooks, J.L., Tierney, P.L., Pang, J., Rossi, A., Young, D., Dlugolenski, K., Guillmette, E., Roy, M.D., Hales, K., Kozak, R., Brain Structure and Function, 2018, 223, 2, 1035
- Fenretinide, Troglitazone, and Elmiron Add to Weight of Evidence Support for Hemangiosarcoma Mode of Action from Studies in Mice, Cook, J.C., Obert, L.A., Koza-Taylor, P., Coskran, T.M., Opsahl, A.C., Ziemek, D., Roy, M., Qian, J., Lawton, M.P., Criswell, K.A., Toxicological Science, 2018, 161, 1, 58
- Efficient Liver Targeting by Polyvalent Display of a Compact Ligand for the Asialoglycoprotein Receptor, Sanhueza, C.A., Baksh, M.M., Thuma, B., Roy, M.D., Dutta, S., Préville, C., Chrunyk, B.A., Beaumont, K., Dullea, R., Ammirati, M., Liu, S., Gebhard, D., Finley, J.E., Salatto, C.T., King-Ahmad, A., Stock, I., Atkinson, K., Reidich, B., Lin, W., Kumar, R., Tu, M., Menhaji-Klotz, E., Price, D.A., Liras, S., Finn, M.G., Mascitti, V., Journal of the American Chemical Society, 2017, 139, 9, 3528
- Detecting Expression of 5T4 in CTCs and Tumor Samples from NSCLC Patients, Pirie-Shepherd, S.R., Painter, C., Whalen, P., Vizcarra, P., Roy, M.D., Qian, J., Franks, T., Coskran, T., Goals, J., Deng, S., Zhong, W., Tucker, E., Marrinucci, D., Gerber, H.P., Powell, E.L., PLoS One, 2017, 12, 7, e0179561
- Measuring T cell responses against LCV and CMV in cynomolgus macaques using ELISPOT: potential application to non-clinical testing of immunomodulatory therapeutics, Kamperschroer, C., O'Donnell, L.M., Schneider, P.A., Li, D., Roy, M.D., Coskran, T.M., Kawabata, T.T., Journal of Immunotox, 2014, 11, 1, 35
- Chemical Modification Study of Antisense Gapmers, R. Stanton, S. Sciabola, C. Salatto, Y. Weng, D. Moshinsky, J. Little, E. Walters, J. Kreeger, D. DiMattia, T. Chen, T. Clark, M. Liu, J. Qian, M.D. Roy, and R. Dullea., Nucleic Acid Therapeutics, 2012, 22, 344
- Pregabalin Induces Hepatic Hypoxia and Increases Endothelial Cell Proliferation in Mice, a Process Inhibited by Dietary Vitamin E Supplementation., Criswell, K.A., Cook, J.C., Morse D., Lawton, M., Somps, C., Obert, L., Roy, M., Sokolowski, S., Koza-Taylor, P., Colangelo, J., Navetta, K., Brady, J., Pegg, D., Wojcinski, Z., Rahbari, R., Duddy, S., Anderson, T., Toxicological Science, 2012, 128, 42
- Quantification of the binding affinity of a specific hydroxyapatite binding peptide., MC Weiger, JJ Park, MD Roy, CM Stafford, A Karim, ML Becker, Biomaterials, 2010, 11, 2955
- Facile Microwave Synthesis of Highly Luminescent Water-Soluble CdSe/ZnS Quantum Dots., M.D. Roy, A. H. Herzing, S.H. De Paoli Lacerda, M.L. Becker, Chemical Communications, 2008, 18, 2106
- Identification of a Highly-Specific Hydroxyapatite-binding Peptide Using Phage Display., M.D. Roy, S.L. Stanley, E.J. Amis, M.L. Becker, Advanced Materials, 2008, 20, 1830
- Quantum Mazes: Luminescent Labyrinthine Semiconductor Nanocrystals Having a Narrow Emission Spectrum., S. H. De Paoli Lacerda, S. D. Hudson, M. D. Roy, J. Johnson, M. L. Becker, J. F. Douglas and A. Karim, ACS Nanotechnology, 2007, 1, 337
- Nucleotide-directed Growth of Semiconductor Nanocrystals., S. Hinds, B. J. Taft, L. Levina, V. Sukhovatkin, C. Dooley, M. Roy, S. O. Kelley, E. H. Sargent, Journal of the American Chemical Society, 2006, 128, 64
- Deconvolution of the Cellular Oxidative Stress Response with Organelle-Specific Peptide Conjugates., K.P. Mahon, T.B. Potocky, D. Blair, M.D. Roy, T.C. Chiles, S.O. Kelley, Chemistry and Biology, 2007, 14, 923, (Cover article)
- Tunable DNA Cleavage by Intercalating Peptidoconjugates., K. P. Mahon Jr., M.D. Roy, J.R. Carreon, E.G. Prestwich J.L. Rouge, S. Shin, S.O. Kelly, Chembiochem, 2005, 7, 766
- Oxidative DNA Strand Scission Induced by Peptides., E.G. Prestwich, M.D. Roy, J. Rego, and S.O. Kelley, Chemistry and Biology, 2005, 12, 895
- Structural Probing of a Pathogenic tRNA Dimer., M.D. Roy, L.M. Wittenhagen, and S.O. Kelley, RNA, 2005, 11, 254
- Interdomain Communication Between Weak Structural Elements within a Disease-related Human tRNA., M.D. Roy, L.M. Wittenhagen, and S. O. Kelley, Biochemistry, 2004, 43, 384
- The Pathogenic U3271C Human Mitochondrial tRNALeu(UUR) Mutation Disrupts a Fragile Anticodon Stem., L.M. Wittenhagen, M.D. Roy, and S.O. Kelley, Nucleic Acids Research, 2003, 2, 596
- Structural Perturbations in Disease-Related tRNAs., S. O. Kelley, L.M. Wittenhagen, and M.D. Roy, Sequence-Dependent Curvature and Deformation in Nucleic Acids and Protein-Nucleic Acid Complexes (ACS Symposium Series; 884), 2004
- Approach for Measuring Total Cellular DNA Damage., M.D. Roy, BioTechniques, 2007, 42
Honors And Awards
- Pfizer Upjohn Research Excellence Awards, 2008
- The National Academies National Research Council Postdoctoral Research Fellowship, 2006
- Boston College Distinguished Graduate Student Research Award, 2005
- Assumption College Presidential Scholar, 1997 - 2001
- National Science Foundation Summer Research Fellowship, 2000
Work Preference
Job Search Status
Open to workWork Type
Full TimeLocation Preference
HybridSalary Range
$199000/yr - $200000/yrTimeline
Toxicologist - Nonclinical Safety
Sarepta Therapeutics
10.2024 - 07.2025
Senior Director - Nonclinical Safety
Strand Therapeutics
06.2023 - 04.2024
Senior Director - Nonclinical Safety
Design Therapeutics
05.2022 - 05.2023
Senior Director - Preclinical Development
Dyne Therapeutics
08.2021 - 05.2022
Director - Preclinical Safety Project Team Lead
Novartis Institute of Biomedical Research
12.2020 - 08.2021
Senior Director - Head of Nonclinical Safety
Sarepta Therapeutics
03.2020 - 11.2020
Director – Investigative Toxicology
Pfizer
10.2017 - 01.2019
Global Molecular Pathology Lead
Pfizer
02.2017 - 10.2017
Principal/Senior Principal Scientist
Pfizer
05.2008 - 12.2011
Assumption College
B.A. from Chemistry
Boston College Graduate School of Arts and Science
Ph.D. from Chemical Biology