Richard Della Puca
Thornwood,USA
Summary
Clinical Research Professional with over 27 years of progressive experience across clinical operations, regulatory compliance, vendor oversight, and project management. Deep therapeutic expertise across oncology, cardiology, CNS, infectious disease, respiratory, vaccines, and rare diseases. Proven leadership in study start-up, FDA audits, ICH-GCP adherence, and cross-functional coordination with sponsors, CROs, and global regulatory agencies. Currently contributing to regulatory initiatives under FDA Code of Federal Regulations, Title 21, and completing an MPH in Epidemiology looking at a unique Artificial Intelligence Platform Deep Leukemic Cloud Platform (DLCP) which is a multi-modal diagnostic and theranostics engine built around four proprietary pillars: the LENA Code, Alercell Epigenetic Clock, LENA Score and the Alercell Digital Twin Theranostics Platform. Each pillar must stand on its own technically, yet the system will only deliver real-world value when these modules are integrated into a single, cloud-hosted workflow. (Outside advisor Mike Krieger Anthropic, Inc.) Columbia University Mailman School of Public Health.
Overview
10
10
years of professional experience
1
1
Certification
Work History
- Longstanding experience as Sr. CRA/PM at CROs and sponsors: Genentech, Novartis, Bayer, Merck, BMS, Pfizer
- Supported pivotal studies for oncology, neurology, GI, rare diseases, and cardiology
- Authored ISS/ISE sections, supported regulatory strategy, and implemented EDC across global sites
Sr. CRA / Auditor FDA
ALLSource Screening Solutions (FDA)
01.2023 - Current
- Led FDA audit preparation and submission for low-sensitivity fentanyl POC test (510k approved).
- Reviewed IQ/OQ/PQ for equipment calibration, ensured protocol compliance, and source documentation accuracy.
- Contributed to CFR Title 21 guidance; performed hospital, manufacturing, and site audits.
- Directly involved in writing guidance draft for the use of AI to Support Regulatory Decision-Making for Drug and Biological Products (CBER)
- And have audited several studies for FDA and big Pharma using AI in clinical research, Oncology platform
Sr. CRA / PM
Siemens Health Diagnostics (via InfoTree & InfoSoft)
01.2021 - 01.2022
- Supported EU MDR compliance for CI-1900 immunodiagnostics platform.
- Oversaw EDC (RAVE/Inform), CRO communications, PMCF deliverables, and data integrity.
- Developed training and communication plans for study coordinators and vendors.
Clinical Trial Lead / PM
Simbec-Orion (CRO)
01.2021 - 01.2022
- Oversaw global monitoring activities, site readiness, and Veeva Vault implementation.
- Managed oncology trials including VCN Oncolytic Platform; ensured compliance with EU Transparency regulations.
Sr. CRA / PM
Covance (via Planet Pharma)
01.2021 - 06.2021
- Managed Phase II/III oncology studies, vendor training, and site contract negotiation.
- Provided FDA audit readiness and RAVE training across multiple trial sites.
Sr. CRA / PM
ICON (Pfizer COVID-19 Vaccine Trials)
09.2020 - 12.2020
- Led regional monitoring for Pfizer’s COVID-19 vaccine trial sites on the East Coast.
- Oversaw eTMF documentation, safety review, and data QC.
Sr. CRA
Sarah Cannon (via Aerotek)
11.2019 - 04.2020
- Managed renal metabolic disorder trials; led CRF reviews and EDC training.
- Provided direct oversight of protocol adherence and site performance during pandemic onset.
Sr. CRA → CTL → Project Manager
PAREXEL Inc.
01.2016 - 01.2019
- Managed CNS and oncology studies for Celgene, Incyte, BMS.
- Coordinated NDA submission efforts, AI-model data integration, and safety trend reporting.
Education
Master of Public Health - Epidemiology
Columbia University, Mailman School of Public Health
Bachelor of Arts - Biochemistry
University of Hartford
West Hartford, CTSkills
- Clinical Trial Monitoring (Phase I–III)
- Regulatory Auditing & 510(k), IND, NDA Submissions
- ICH-GCP, FDA, EMA, EU MDR Compliance
- Vendor Oversight & Site Contract Negotiation
- Study Start-Up through Close-Out
- CAPA Writing, Audit Prep & Inspection Readiness
- Cross-Functional Leadership & CRA Training
- Advanced Data Integrity & Source Verification
Certification
- Certified Clinical Research Associate
- EDC: Medidata RAVE, REDCap, Medrio, Oracle Inform, Bioclinica EDC
- Statistical Tools: SAS, R, Python
- PM Tools: Agile, Waterfall, GrantManager, Veeva Vault, Viva Vault
- Regulatory Tools: FDA Gateway, EU MDR, XIM, RIM, Changepoint
- MS Office Suite: Excel (Advanced), Teams, Word, PowerPoint, Outlook
- Familiar with AI-enhanced clinical research tools and oncology modeling platforms like Anthropic
PUBLICATIONS & RESEARCH
- Contributor to FDA CFR Title 21 for Sponsors & Investigators (2022)
- Peer-reviewed publications available upon request
- MPH research: AI-powered oncology data mining using deep learning framework
THERAPEUTIC AREA EXPERIENCE
- Oncology: CAR-T, NSCLC, RCC, Breast, Brain Tumors (GBM), Myeloma, CRC, Hepatic, MDS
- AI Platform evaluation understanding the AI’s Sequential Diagnosis Benchmark
- CNS & Mental Health: MDD, Bipolar, Schizophrenia, ADHD, Psychosis
- Cardiovascular / Metabolic: CHF, Hypertension, Hyperlipidemia, Type I Diabetes
- Respiratory: Asthma, COPD, Severe Asthma, Cystic Fibrosis
- Infectious Diseases: COVID-19, Hepatitis A, BARDA
- Gastrointestinal: GERD, Crohn’s, Peptic Ulcers, Ulcerative Colitis
- Rare / Autoimmune Disorders: Acoustic Neuroma, Alopecia, Psoriasis
- Devices & Diagnostics: Siemens Atellica CI-1900, Insulin Devices, IVD Platforms
Languages
Spanish
Professional Working
Timeline
Sr. CRA / Auditor FDA
ALLSource Screening Solutions (FDA)
01.2023 - Current
Sr. CRA / PM
Siemens Health Diagnostics (via InfoTree & InfoSoft)
01.2021 - 01.2022
Clinical Trial Lead / PM
Simbec-Orion (CRO)
01.2021 - 01.2022
Sr. CRA / PM
Covance (via Planet Pharma)
01.2021 - 06.2021
Sr. CRA / PM
ICON (Pfizer COVID-19 Vaccine Trials)
09.2020 - 12.2020
Sr. CRA
Sarah Cannon (via Aerotek)
11.2019 - 04.2020
Sr. CRA → CTL → Project Manager
PAREXEL Inc.
01.2016 - 01.2019
Bachelor of Arts - Biochemistry
University of Hartford
Master of Public Health - Epidemiology
Columbia University, Mailman School of Public Health