Justin Bader Email & Phone Number

Cambridge, England, GB

Cambridge, MA, US

• Served as Clinical Pharmacology Lead for a novel antimicrobial compound
• Oversaw Phase I renal insufficiency and bronchoalveolar lavage studies frominitiation through CSR development
• Led a cross functional team through development and execution of a PK/PDpackage (in vitro/in vivo studies, population PK modeling, and simulation) togenerate translational data and inform dose selection for Phase.
• Contributed to planning of pharmacometrics aspects of a Phase III pediatric studyto optimize study enrollment and dosing
• Managed external vendors for the execution of preclinical studies andmodeling/simulation analyses
• Provided Clinical Pharmacology and DMPK background, planning, andquestions for pIND briefing book

Newton, MA, US

• Served as Clinical Pharmacology Lead for numerous Phase I, II, and III Clinical and Clinical Pharmacology studies in oncology
• Contributed to the development of a novel biomarker immunoassay and managed use of this assay within clinical trials (ie, special considerations and logistics for sample collection, processing, and analysis)
• Collaborated with pharmacometrics vendors and clinical pharmacology team to evaluate population PK and exposure-response analyses and reporting

Newton, MA, US

• Contributed to three oncology Supplemental New Drug Applications (sNDAs) through various deliverables such as leading the development of Module 2.7.2 and review of Modules 2.7.3, 2.7.4, and 2.5
• Frequently addressed FDA and EMA inquiries and requests in coordination with multiple functional areas
• Led pharmacokinetic analyses using non-compartmental and regression-based techniques
• Managed bioanalytical and central lab vendors to coordinate the transport and assay of study samples, accounting for special logistical and scientific considerations needed to ensure sample integrity
• Collaborated cross-functionally to develop data transfer agreements, electronic case report forms, SDTM and ADaM datasets, laboratory manuals, requisition forms, work orders, study budgets, etc

Schenectady, NY, US

• Regularly led, executed, and advised on a diverse array of pre-clinical and clinical PK and PK-PD projects in a scientific capacity
• Contributed greatly to the design and conduct of simulation based analyses to support clinical dose selection
• Managed and coordinated the execution of pre-clinical in vivo studies
• Obtained and evaluated data and study reports from industry Sponsors in order to ensure all analysis inputs were available to perform robust PK and PK-PD analyses
• Interpreted PK and PK-PD analysis output in order to lead the development of regulatory quality reports
• Designed, managed, and led a two-day MSL training program about pre-clinical and clinical pharmacometrics analyses and studies

Schenectady, NY, US

• Gained a knowledge of clinical trial design, exposure-response relationships, infectious diseases, microbiology, pharmacometrics, and translational medicine
• Regularly contributed to the design and development of scientific abstracts, manuscripts, posters, presentations, proposals, and reports
• Participated as a key contributor in the strategic development and filing of US and international patents
• Collaborated with numerous cross-disciplinary professionals in the creation of NIH grants
• Supported the development, management, and marketing of the PK-PD Compass, a mobile device application designed to assist clinicians in the selection of optimal IV antibiotic therapy
• Participated in strategic marketing activities including the construction and planning for advertisements, brochures, messaging documents, a trade show booth, and websites

Deerfield, IL, US

Dublin, Ireland, IE

Buffalo, New York, US

Waltham, MA, US