Michael Trujillo
Neuroscientist with experience in product development, clinical trials, and clinical affairs specialist
Benicia,CA
Summary
Experienced Clinical Affairs Specialist with a proven track record of clinical validation, FDA regulatory processes, product development, product launch, product marketing, and sales. Skilled in Electrophysiology, Live Cell Imaging, Stem Cell Biology, Cell Culture, Scientific Writing, and Pharmacology & Toxicology of Clinical and Preclinical drug compounds.
Overview
21
21
years of professional experience
Work History
Senior Product Manager
Jackson Laboratory
Sacramento, CA
10.2021 - 02.2026
- Guide strategic leadership and enhancement of neurobiology preclinical services featuring efficacy proof-of-concept, biodistribution, biomarker pharmacology, and translational neuroscience offerings.
- Serve as internal subject matter expert on nonclinical study quality systems and adherence to 21 CFR Part 58 – Good Laboratory Practice (GLP) for nonclinical laboratory studies, consulting scientific operational and commercial teams on regulatory frameworks and study execution methodologies.
- Guide design and conduct of studies aimed at supporting regulatory submissions, ensuring adherence to 21 CFR Part 58 regulations, applicable FDA guidance, and industry best practices for IND-enabling programs.
- Developed product roadmaps and commercialization strategies for neurodegenerative and neurodevelopmental diseases. Focused on service portfolios including ALS, Alzheimer's, Parkinson's, Huntington's, Rett syndrome, Angelman syndrome, Dravet syndrome, CDKL5 deficiency disorder, Friedreich's ataxia, spinal muscular atrophy, muscular dystrophies, and Charcot-Marie-Tooth disease.
- Serve as key scientific and commercial advisor aiding customers in advancing gene therapies, antisense oligonucleotides (ASOs), small molecules, protein replacement therapies, RNA-based therapeutics, and genome editing technologies.
- Collaborate with clients, study directors, quality assurance personnel, and research teams to advise on suitable study strategies, encompassing evaluation of when studies should adhere to GLP-compliant conditions as outlined by 21 CFR Part 58, be executed as non-GLP exploratory studies, or utilize a hybrid approach to achieve targeted program objectives.
- Collaborated with research scientists and operations teams to integrate quality systems into service offerings. Ensured protocol and amendment management met established standards. Managed standard operating procedures (SOPs) for operational efficiency. Oversaw raw data collection and retention processes to maintain accuracy. Maintained equipment calibration and maintenance records for reliable operations. Documented personnel training to uphold compliance and operational integrity. Controlled test article accountability for rigorous quality assurance. Supervised facility and environmental controls to ensure regulatory adherence.
- Guide customers in developing robust, reproducible, and regulatory-defensible datasets appropriate for IND applications, investigator brochures, pre-IND meetings, and various FDA interactions.
- Developed scientific marketing collateral, including white papers and webinars on neuroscience drug development. Created conference presentations and thought leadership content focused on translational biomarkers. Implemented GLP principles under 21 CFR Part 58 within preclinical neuroscience programs. Produced engaging materials to effectively communicate complex scientific concepts.
- Evaluate emerging technologies, biomarkers, animal models, and neuroscience research trends to identify opportunities for portfolio expansion while maintaining awareness of evolving regulatory expectations impacting nonclinical safety and efficacy assessments.
- Led cross-functional teams to define product roadmaps, improving alignment with customer needs.
- Implemented Agile methodologies to streamline product development, enhancing team collaboration and efficiency.
- Developed go-to-market strategies that increased product adoption and drove market share growth.
- Facilitated user research to gather insights, resulting in data-driven product enhancements and improved user experience.
- Analyzed competitive landscape to inform product positioning, ensuring strategic alignment with market trends.
- Increased product adoption by identifying customer needs and developing innovative product features.
Vice President of Clinical Affairs and Data Science
Karuna Labs, Inc.
01.2019 - 10.2021
- Supervised Regulatory Affairs and Quality Management for FDA and California FDB medical device regulations
- Developed Quality Management System
- Work with QA, RA and R&D to insure compliance with protocols & evaluations
- Managed clinical strategy to validate Virtual Reality platform engineered to treat chronic pain
- Supervised Clinical Research team to conduct mechanistic and randomized controlled trials research studies
- Developed clinical studies protocols to assess the psychological and physical benefits of digital therapeutics
- Submitted grant application through the NIH/SBIR, insurance companies, and global pharma companies
- Established clinical partners and clinical protocols for the treatment of chronic pain
- Established remote patient monitoring to evaluate patient progress in neuroplasticity-based digital therapeutics
- Led the development and implementation of data-driven strategies, improving clinical trial efficiency and outcomes.
- Oversaw cross-functional teams to enhance patient engagement, resulting in improved recruitment metrics for clinical studies.
- Directed the analysis of clinical data using advanced statistical tools, facilitating informed decision-making across departments.
- Implemented robust data governance frameworks, ensuring compliance with industry regulations and improving data integrity.
Global Product Manager
Alpha MED Scientific
Osaka, Japan
10.2016 - 01.2019
- Product Development and Marketing Manager for the MED64Presto, a high-throughput in vitro electrophysiology platform for toxicology and pharmacology
- Effectively managed and provided direction to engineers and software developers to implement key neural and cardiac technologies into the platform based on beta tester feedback and key opinion leaders
- Defined product scope, goals, and deliverables to ensure consistency with company strategy and commitments
- Created marketing collateral such as product brochures, application notes, user manuals and exhibition material
- Worked with strategic partners (stem cell manufacturers) to create joint marketing collateral
- Represented Alpha MEDon global consortium charged with identifying new technologies for predictive pharmacology and toxicology screening for major pharmaceutical companies
- Successfully managed product development cycle to ensure a successful world wide product launch
GlobalMarketing Manager
SonyBiotechnology
08.2015 - 10.2016
- Sales and Marketing Product Manager for Sony's live cell imaging in vitro microscopy platform, the SI8000
- Managed the launch of the SI8000in North America and Europe
- Created marketing and exhibition content aimed at strategic market segments for basic research, safety pharmacology, toxicology, and oncology
- Managed procurement operations within North America and European countries
- Managed sales staff, application scientists, and service engineers to ensure quality control for demos and post-sales installation procedures and training
- Served as the imaging platforms liaison between the Sony corporate office in Tokyo and the North American and European Biotechnology offices
Senior Application Scientist
Alpha MEDScientific
04.2014 - 08.2015
- Served as the liaison between Alpha Med corporate office in Osaka, Japan and North American distributor AutoMate Scientific in Berkeley, CA
- Lead marketing and branding efforts in North America for the MED64multi-electrode array (MEA)
- Created marketing materials such as conference booth materials, user manuals, application notes, sales tools, and demo scripts
- Conducted direct-to-consumer campaigns such as email and search engine marketing
- Created brand awareness by managing new product and digital content releases
- Introduced several new applications for the MED64system such as drug discovery assays and in vivo phenotypic assays
- Promised and published content for the MED64.com website
- Maintained all responsibilities of the Sales Scientist position indicated below
Sales Scientist
Alpha MEDScientific
04.2012 - 04.2014
- Technological sales leader for in-vitro electrophysiology applications in North America and Europe
- Utilized expertise in primary and stem cell-derived cell cultures as well as acute and organotypic tissue preparations to expand global marketing applications for neuroscience, pharmacology, and toxicology
- Conducted demos, closed sales, and provided training for the MED64Multi-Electrode Arrays at various universities, pharmaceutical, and biotech companies in North America, Europe, and the Middle East
- Gave marketing and sales presentations and exhibited at conferences such as the Society for Neuroscience, Biophysical Society, Safety Pharmacology Society, and International Stem Cell
- Increased annual sales volume and revenue within the first nine months as the Sales Scientist
Neuroscience Research Associate
Posit ScienceCorporation
03.2005 - 09.2007
- Associate member of Research and Development team that developed and assessed Neuroplasticity-based cognitive training tools
- Using MatLab and other statistical software, managed large-scale pre-market evaluation of Auditory and Visual psychophysics cognitive training modules.
- Managed collaborations to pilot test programs in retirement communities and with academic partners.
- Presented results at international scientific conferences and represented the company in press interviews, including the Wall Street Journal and Good Morning America.
- Led the preclinical development of a sensory-motor rehabilitation module, including hardware and software development, which led to an approved patent
Education
PhD - Neuroscience
University of California, Riverside
Riverside06-2012
Masters of Science - Kinesiology
San Francisco State University
San Francisco05-2005
Bachelor of Science - Kinesiology
San Francisco State University
San Francisco, CA05-2003
Publications
- Trujillo MS, Alvarez AF, Nguyen L, Petros J.Embediment in Virtual Reality for the Treatment of Chronic Low Back Pain: A CaseSeries.J Pain Res. 2020;13:3131-3137.
- Trujillo, M. S., Russell,D.M., Anderson, D.I., Mitchell, M. (2018).Grip force control using prosthetic and anatomical limbs. Journalof Prosthetics and Orthotics, 30(3), 132-139
- Trujillo, M.S.,Anderson, D.J., Mitchell, M. (2014).Grip force using an artificial limb in a congenital amputee. Open Journal of Therapy and Rehabilitation.02(03), 97-105
- Trujillo, M.S.,Razak,K.A.(2013).Altered cortical spectrotemporal processing with age-related hearing loss.Journal of Neurophysiology, Volume 110(12), 2873-2886
- Trujillo, M.S., Carrasco,M.M., & Razak,K.A.(2013).Responseproperties underlying selectivity for the rate of frequency modulated sweeps in the auditory cortex of the mouse. Hearing Research,Volume 298, April 2013,80-92.
- Trujillo, M.S.,Measar, K., Carrasco, M. M., & Razak,K.A.(2011). Selectivity for the rate of frequency-modulated sweeps in the mouse auditory cortex. Journal of Neurophysiology, Volume 106(6),2825-2837
- Carrasco,M.M., Trujillo, M.S., Razak,K.A.(2013).Development of response selectivity in the mouse auditory cortex. Hearing Research, Volume 296, Feb. 2013, 107-120.
- Rotschafer, S.E.,Trujillo, M.S.,Dansie, L.E.,Ethell, I.M., & Razak,K.A.(2012). Minocycline treatment reverses ultrasonic vocalization production deficit in a mouse model of Fragile X Syndrome. Brain Research,Volume 1439(0),7-14
- Wallace, S.A.,Anderson, D.I., Trujillo, M.S., & Weeks, D.L. (2005). Upper extremity artificial limb control as an issue related to movement and mobility in daily living. Quest, Volume 57(1),124-137
- Barbu-Roth, M., Anderson, D.I., Despres, A., Streeter, R.J..Cabrol, D., Trujillo. M.S., Campos, J.J.,Provasi,J.(2014). Air stepping in response to optic flows that move toward and away from the neonate. Developmental Psychobiology,56(5),1142-1149
Patents
- Merzenich MM, Delahunt PB, Mahncke HW, Trujillo MS, Hardy JL,inventors; Posit ScienceCorp, assignee. Joystickfor training to improve sensory-guided fine motor control of the hand. United States patent US8,206,156.2012Jun26.
- Nguyen L,GeselowitzLA, Trujillo MS,inventors. Methods and systems of embodiment training in a virtual-reality environment. United States patent application US 16/380,425. 2020 May 28.
Timeline
Senior Product Manager
Jackson Laboratory
10.2021 - 02.2026
Vice President of Clinical Affairs and Data Science
Karuna Labs, Inc.
01.2019 - 10.2021
Global Product Manager
Alpha MED Scientific
10.2016 - 01.2019
GlobalMarketing Manager
SonyBiotechnology
08.2015 - 10.2016
Senior Application Scientist
Alpha MEDScientific
04.2014 - 08.2015
Sales Scientist
Alpha MEDScientific
04.2012 - 04.2014
Neuroscience Research Associate
Posit ScienceCorporation
03.2005 - 09.2007
PhD - Neuroscience
University of California, Riverside
Masters of Science - Kinesiology
San Francisco State University
Bachelor of Science - Kinesiology
San Francisco State University