Joseph Reitano

About Joseph Reitano

Passionate clinical research professional with 23 years of extensive experience in small biotech data management overseeing data management activities for oncology studies, including gastric cancer, cholangiocarcinoma, and unresectable hepatocellular carcinoma. Contributed to regulatory submissions, including a successful NDA, by directing end-to-end data management deliverables from protocol design to submission. Collaborating cross-functionally with Biostatistics, Clinical Operations, Regulatory Affairs, and QA, the team ensured data quality and program efficiency. Skilled in Good Clinical Practice (GCP), with expertise in oncology data management and a focus on precision and compliance. Dedicated to advancing clinical research through robust data management practices.

Experience

1. Director, Clinical Data Management (Oncology)

   Elevar Therapeutics

   May 2022 — Present · Fort Lee, NJ, US

   Oversaw data management activities across studies in gastric cancer, cholangiocarcinoma (CCA), adenoid cystic carcinoma (ACC), and unresectable hepatocellular carcinoma (uHCC), contributing to a successful NDA submission.(Portfolio included 4 Phase 1, 3 Phase 2, and 1 Phase 3 studies.)Key Achievements: • Advanced to lead data management function based on oncology expertise and team leadership. • Directed end-to-end data management deliverables from protocol design through regulatory submissions (NDA/MAA/PMDA). • Partnered cross-functionally with Biostatistics, Programming, Clinical Operations, Clinical Development, Regulatory Affairs, and QA to ensure data quality and program efficiency. • Oversaw CRO deliverables and supported departmental budgeting and cost tracking. • Authored and reviewed key regulatory documents, including the Study Data Standardization Plan (SDSP).Posters/Abstracts:AACR 2023 Poster: Effect of Rivoceranib on the Pharmacokinetics of Cytochrome P450 Enzyme Substrates: A Phase 1 Trial in Healthy VolunteersAACR 2024 Abstract: Effect of Rivoceranib Administered as 200 mg Once Daily on the Pharmacokinetics of CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4 SubstratesEffect of Rivoceranib 200 mg Once Daily on the Pharmacokinetics of Cytochrome P450 Enzyme Substrates: A Phase 1 Trial in Healthy VolunteersESMO Abstract: A Pharmacokinetic Interaction Study Between Rivoceranib and Cytochrome P450 Enzymes (CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A) Substrates

Education

• William Paterson University of New Jersey

  BS, Biology/Chemistry

• Thomas Edison State University

  Graduate Certificate in Clinical Trial Managment

  2014 — 2015

Skills

• Inform
• Edc
• Therapeutic Areas
• Pharmacology
• Ctms
• Regulatory Affairs
• Lifesciences
• Pharmacovigilance
• Gmp
• Sas
• Clinical Development
• Medidata
• Regulatory Submissions
• Neurology
• Clinical Data Management
• Oracle Clinical
• Medical Writing
• Biostatistics
• Oncology
• Protocol
• CRO
• Clinical Trials
• Medical Devices
• Clinical Research
• Diabetes
• Crf Design
• Glp
• Pharmaceutical Industry
• Sop
• Fda
• Meddra
• Validation
• Phase I
• Pharmaceutics
• Drug Discovery
• Vaccines
• Hematology
• Immunology
• Data Management
• Cdisc