Clinical Study Director

Juan Reyes, DVM, MS

Piscataway, NJ *****

Tel.: 732-***-****

Email: ************@*****.***

Summary:

Accomplished clinical and non-clinical researcher with over 20 years of experience leading complex projects from concept through post-approval in the pharmaceutical and medical device industries. Expertise in scientific research methodologies, with a proven track record of delivering verifiable results. Dedicated to advancing clinical research through precision, quality, and effective coordination, while maintaining full compliance with regulatory standards. Seeking a Director-level or higher position to oversee the development and implementation of innovative medical products and technologies that drive meaningful improvements in global health outcomes. Education:

Institution Name, Country Education / Degree

University of Missouri, Columbia, MO Master of Science (MS) Universidad Autonoma de Santo

Domingo, DR

Doctor of Veterinary Medicine (DVM)

Therapeutic Area and Products:

Led successfully clinical and non-clinical from concept to post-approval with different medical products PK, PD, prevention, interventional (safety, tolerability, and efficacy), observational, quality of life, diagnostic with healthy volunteers and patients (male and female adults, and pediatrics), as applicable.

Cardiovascular: Managed REVIVE 1 and REVIVE clinical trials – “Effect of Levosimendan on the Short- term Clinical Course of Patients with Acutely Decompensated Heart Failure.”

CNS: Alzheimer’s Disease, Parkinson’s Disease, Schizophrenia, headache, dental pain. prescription and OTC products in Phase 1, 2, 3, 4.

Dermatology: a) Pre-clinical research of absorbable micro suture anchors for rhytidectomy (aesthetic surgery), b) Phase 3 testing of Acticoat on burn wounds to secure marketing approval in the U.S.

Gastroenterology: Monitoring of gastrointestinal SAEs and AEs.

Hematology: a) Constant testing in clinical and pre-clinical study protocols for over 20 years, b) Managed rare disease (Hemophilia) clinical study protocols.

Infectious diseases: Manufactured anti-rabies vaccines in bioreactors based on virus growth in brain of lactating mice and cell culture for clinical administration to human. Managed hepatitis clinical projects Phase 3.

Inflammation (RA): Celecoxib - nonsteroidal anti-inflammatory drugs (NSAIDs).

Cardiovascular, Hematology: a) Levosimendan (REVIVE I and II), b) Maraviroc (chemokine receptor-5 antagonist), c) CE-224,535 (selective antagonist of the human P2X7 receptor disease modifying anti- rheumatic drugs [DMARD]), d) PD-0360324 (humanized immunoglobulin (Ig) G2 monoclonal antibody

(mAb) directed against the cytokine colony stimulating factor 1 [CSF1]).

Inflammation: Rheumatoid arthritis (RA) – Managed numerous clinical study protocols.

Immuno-oncology (cancer):

Prostatic adenocarcinoma diagnosis and treatment.

Grew colon cancer and lymphoma tumors based on cell culture and pre-clinical laboratory procedures.

Tested and developed of radio-labeled monoclonal antibodies (PK / PD, MTD, dose escalation, observational) to trace and target small cancer tumors - colon cancer and lymphoma.

Musculoskeletal: Burn wounds, musculoskeletal wounds repair.

Ophtalmology: Worked retinal dystrophy clinical study protocols Phase 3.

Rare disease: Hemophilia, Down Syndrome.

Respiratory: Managed Asthma, respiratory infections clinical studies; clinical knowledge of sinusitis, sleep apnea.

Juan Reyes Page 1 of 4 2025

Juan Reyes, DVM, MS

Piscataway, NJ 08854

Tel.: 732-***-****

Email: ************@*****.***

Medical devices and electro-surgical equipment: Managed non-clinical protocols for Acticoat, absorbable and metallic suture anchors (PANALOK, Mitek), H-device for meniscus repair, scissors and forceps for arthroscopy, arthroscopy shaver systems, bipolar scissors for open surgery, electrosurgical equipment for bone remodeling, feminine menstrual pads.

OTC and Consumer Products: Guaifenesin, NSAIDs, aspirin iterations, and nicotine (abuse liability research aimed to reduce combustion harm on human health), among other products.

Inflammation: Celecoxib, Maraviroc (chemokine receptor-5 antagonist) for RA indication, CE-224,535 (selective antagonist of the human P2X7 receptor disease-modifying antirheumatic drugs [DMARD]), PD-0360324 (humanized immunoglobulin (Ig) G2 monoclonal antibody (mAb) directed against the cytokine colony stimulating factor 1 [CSF1]), Phase 1 - Phase 4.

Managed project operations of global and regional research with biologics, pharmaceutical, prescription, OTC, medical device, electrosurgical equipment, IVD, and consumer products.

Expertise in overseeing and leading global clinical teams and respective interventional (registry) and non-interventional projects following FDA and EMA regulations and guidelines, ICH-GCP standards. Work Experience:

Associate Director / Director, Clinical Project Management ClinChoice – Piscataway, New Jersey 2022 – 2022

Responsible for the successful scientific design, planning, initiation, execution, and closeout of clinical research projects. Assure the accurate transfer of clinical research data and study results from proposal through project completion. Directly and functionally responsible for direct reports in the clinical studies division and assigned project team members. Oversee and manage the vetting and contract award of CROs and service providers for clinical research protocols based on effective communication, process documentation, and compliance with ICH/GCP and company procedures. Associate Director, Project Management

Endo Pharmaceuticals, KPS Life, LLC, Piscataway, NJ 2020 – 2020

Provided clinical and non-clinical science and project management services within musculoskeletal therapeutic.

Associate Clinical Lead Director

Vaco Healthcare, Quintiles, Inc. / IQVIA, Piscataway, NJ 2016 – 2018 Provided global project team, program/project management. Therapeutic experience: immunology, inflammation (RA), respiratory (A1PI deficiency and chronic obstructive pulmonary disease (COPD), ophthalmology, rare disease (hemophilia), women reproductive health (menopause, menstrual cycle).

Supervised clinical project set-up activities, execution, and close-out through tracking systems.

Re-aligned the responsibilities & roles of the RA and QA departments to better support corporate goals & objectives.

Recommended regulatory approach to expand product market.

Provided GCP and GMP guidelines for pharmaceutical, medical device, and institutions engaged in product testing, development, production, and marketing in different regions.

Reviewed and authored product development – regulatory sections for IND, NDA, 510(k) for a wide range of therapeutic areas and indications.

Supervised the operational aspects of projects to meet contractual requirements and in accordance with SOPs, policies and practices.

Accountable for eligible subject enrollment and generation of accurate clinical data to meet contract.

Ensured overall projects and studies conducted under Risk Based Monitoring met delivery requirements.

Juan Reyes Page 2 of 4 2025

Juan Reyes, DVM, MS

Piscataway, NJ 08854

Tel.: 732-***-****

Email: ************@*****.***

Ultimate accountable for patient safety, wellness, privacy and for delivery of accurate, reliable, valid, and verifiable project results.

Industry Training

Project Management (PM), Rutgers University, New Brunswick, NJ 2014 – 2014 Master Scientist, Research Division

R.J. Reynolds, Winston-Salem, NC 2013 – 2014

Project Management for Research Division: Managed Abuse Liability project under the FDA jurisdiction, company SOP, and best practices to protect human subjects and public health.

Participated in the biannual updates of SOP to prepare the essential documents.

Led in-house colleagues for sound research design and initiation of project. Industry Training

Certified Clinical Research Associate (CCRA®), ACRP. 2012 – 2012

Project Management (PM), Eastern Connecticut State University, Willimantic, CT. 2011 – 2011 Senior Clinical Research Manager

Yoh Services / Bayer HealthCare, Morristown, NJ 2010 – 2011 Clinical Study Management: Led clinical study team comprised of, but not limited to Medical Affairs, Project Management Department, Regulatory Affairs, Quality Assurance, Statistics Department, Data Management, Clinical Supplies and Clinical Study Monitoring departments, CRO project teams and study vendors or providers – EDC, IVRS, laboratories, imaging.

Managed the design and writing protocol, initiation, planning, execution and close-out process for 6-7 global interventional (registry: https://clinicaltrials.gov/), but mono-center fast paced clinical PK and dental studies at different stages to test iterations of oral OTC products for pain management – headache, dental.

Co-monitored and monitored respective interventional clinical protocols in Mexico and the US. Senior Clinical Affairs Consultant

Ximedica, LLC, Providence, RI 2009 – 2009

Clinical Project Management: Provided clinical project / study management and clinical study monitoring, for global and domestic clinical studies for the biotechnology, pharmaceutical, medical device, medical equipment, and CRO industries.

Associate Director, Clinical Protocol Manager

Pfizer, Inc., New London, CT 2008 – 2009

Global Clinical Study Management for the Inflammation Department: Led simultaneously three (3) separate global clinical project teams.

Developed overall project strategies, with respective Risk Mitigation, leading cross-functional project departments to design, plan, initiate, perform, and close-out multiple inflammation global clinical studies within programs alignment and approved resources while maintaining high degree of quality assurance.

Developed and performed Audit Preparedness Plan for 20+ global clinical studies for the Clinical Studies Division.

Oversaw successful planning and hosting of face-to-face investigator meetings for Latin America

(LATAM): one (1) in Buenos Aires, Argentina, Asia and Europe: two (2) in the Czech Republic, and US: one (1) in Florida, US, and numerous virtual investigator meetings. Juan Reyes Page 3 of 4 2025

Juan Reyes, DVM, MS

Piscataway, NJ 08854

Tel.: 732-***-****

Email: ************@*****.***

Senior Clinical Study Manager

Adams Respiratory Therapeutics, Chester, NJ 2007 – 2007 Clinical Study Management for oral Mucinex Seasonal Clinical Study: Managed CRO (TKL Research) clinical project team (one project manager and 16 senior clinical research associates) for study design and protocol writing, planning, initiation, execution, and close-out process a seasonal clinical study to test Mucinex an OTC product – respiratory system.

Performed development and writing of seasonal clinical study protocol and investigator brochure

(IB) for OTC products.

Oversaw clinical study activities: start-up, recruitment, conduct, and close-out.

Provided significant input (improvement) for established bi-annual SOP review. Senior Clinical Research Consultant

Pharmaceutical Development Services, LLC, Lewes, DE 2007 – 2012 Clinical Research Services: Provided clinical project / study management and clinical study monitoring, for global and domestic clinical studies for the biotechnology, pharmaceutical, medical device, medical equipment, and CRO industries.

Clinical Project Manager

Aerotek / Schering-Plough, Kenilworth, NJ 2006 – 2006 Retrieved and transferred regulatory packages corresponding to global clinical study to global central trial master file (TMF).

Clinical Project Manager

UnitedHealth Group / Sanofi-Aventis, Bridgewater, NJ 2004 – 2006 Clinical Study Management: oral Telithromycin (Ketek®) among other Respiratory Rx Products: Oversaw contracted CRO and vendors (e.g.: Covance, IntraLinks, ePharma Solutions) on clinical project team activities that led to successful planning, conduct, and close-out of outsourced multi- center and multiple (10+) Key Opinion Leaders Investigator Initiated Trials (IITs) or Investigator Sponsored Trials

(IST) to test anti-infective and prescription products for Respiratory System in adult and pediatric population.

Certifications & Training:

Clinical Development and Regulatory Affairs, Mercer County Community College, West Windsor, NJ.

Project Management (PM), Rutgers University, New Brunswick, NJ.

CDISC Standards in the Clinical Research Process (CDASH and SDTM), Clinical Data Interchange Standards Consortium.

Project Management (PM), Eastern Connecticut State University, Willimantic, CT.

Foundations of Clinical Research and Drug Development, Mercer County Community College, West Windsor, NJ.

Network Engineer (NE), PCAge, Certified Career IT Institute, Edison, NJ.

Fundamentals of Clinical Research and Drug Development, Kendle University, Cranford, NJ. Skills:

Bilingual: English/Spanish.

Microsoft Office Software.

CR / DM / RA / PV / NE Software.

Juan Reyes Page 4 of 4 2025

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