Experience

Halloran Consulting Group, Inc.

• United States
• Business Consulting and Services
• 100 - 200 Employee

• Vice President, Strategy and Program Leadership

  • Aug 2021 - Present

  Head of Strategy & Program Leadership practice area for Halloran, focusing on program and development team leadership, project-based deliverables such as asset, indication or target due diligence, integrated development plans, and new company formation initiatives. Team leader of development programs for biotech and pharma sponsor companies across therapeutic areas and development lifecycles (pre-IND through registration). Team and strategic leadership for viral and non-viral gene therapies, edited and unedited cell therapies, polyclonal and monoclonal antibodies, and small molecules for rare disease, oncology, autoimmune and infectious disease indications.

• Principal Consultant, Strategy & Program Leadership

  • Aug 2019 - Present

  - Program and Development Team Leadership- External Innovation, Asset and Target Due Diligence - Competitive Intelligence- Integrated Development Plans- Portfolio Prioritization - Pre-clinical and Translational Research Support- Clinical Development and Regulatory Interaction Strategy



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinician, Director

  • Oct 2014 - Aug 2019

  Clinical scientist with Pfizer Rare Diseases, supporting translational drug development, first-in-man and Phase 1 / Phase 2 clinical trials, including proof-of-concept studies, predominantly in non-malignant hematology (hemophilia, acute hemorrhage, sickle cell).Clinical lead and clinical scientist responsibilities include clinical development plans, regulatory submissions, study designs, protocol authoring, clinical trial oversight and conduct (including management of CROs), data review and analysis, clinical study reporting, and study abstract/manuscript development.



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Research Scientist / Clinical Trial Leader

  • Jan 2013 - Oct 2014

  Clinical Research Scientist and Clinical Trial Leader (CTL), working with Novartis physicians, responsible for Phase II-IV global, multicenter vaccine clinical trials in meningitis and sepsis. Primary CTL responsibilities include oversight and leadership of Novartis global clinical trial teams, which consist of CTMs/COMs, CRAs, Biostatisticians, Medical Writers, Data Coordinators and data management CROs. Leader of clinical trial kickoff meetings and regular trial update meetings. Primary central contact for clinical trial team.Lead author of Clinical Study Protocols and amendments; lead author of or key contributor to Informed Consent Forms, Subject Diary Cards, Clinical Development Plans, Case Report Forms and EDC, Investigator Brochures, Statistical Analysis Plans, Clinical Study Reports, DMC charters, Clinicaltrials.gov and EUDRACT registrations, FDA/EMA regulatory briefing books, DSURs/PSURs and IMPDs.Primary lead on systematic scientific literature reviews, white papers, and briefing documents for Novartis strategic decision meetings. Clinical development representative on cross-functional teams with Project Management, Technical Development, Research, Regulatory, Marketing, and Medical Affairs.Accountable for project milestones including synopsis/protocol development, study budget, site selection, IRB/ethics submissions, trial registration, study initiation, patient enrollment, data management, study closure, database lock, study reporting, and clinical quality objectives.Trial management and execution responsibilities include overview of data management and development of Data Listing Review plans, SAE/AE narrative and safety data review, protocol deviation review, operational updates to senior management on study timelines, budget, and quality. Operational responsibilities include GCP audit corrective actions, data listing reviews and AE/SAE reconciliation.



Advanced BioHealing, Inc.

• Medical Device
• 1 - 100 Employee

• Senior Clinical Research Scientist

  • Feb 2007 - Feb 2013

  Clinical Scientist responsible for Phase II/III clinical trials of a bioengineered dermis in wound healing indications, including diabetic foot ulcers, venous leg ulcers, pressure ulcers, and epidermolysis bullosa. As a Clinical Scientist, member of global clinical trial team executing multicenter pivotal medical device/biologics registration studies. Primary trial execution responsibilities included site selection, initiation, and monitoring, EDC setup, budget accountability, data listing and query review. Primary trial management responsibilities included management and oversight of CROs for data management, quality, and biostatistics. Lead author or key contributor to Clinical Study Protocols, Informed Consent, Clinical Development Plans, Case Report Forms, Investigator Brochures, Statistical Analysis Plans, Clinical Study Reports, Integrated Summary of Safety/Efficacy reports, regulatory briefing books, DSURs/PSURs and IMPDs.Supported clinical development strategy, marketing, and health economics through data mining and statistical analysis of clinical trial datasets using SAS, Minitab, and Matlab. Member of Scientific Affairs publication groups focusing on abstract and medical journal literature development; served as lead or co-author on multiple publications.Attended global scientific conferences, Scientific Advisory Board meetings, and key opinion leader presentations.



Mitek Sports Medicine

• Medical Equipment Manufacturing
• 100 - 200 Employee

• Engineer II

  • 2006 - 2007

  Quality and manufacturing process support for spinal implant and arthroscopic design devices. Primary responsibilities included the selection and qualification of external manufacturing vendors for instruments and implant components.Lead author or key contributor of technical validation reports including IQ/OQ/PQ and Process Verification focusing on capability analysis and statistical process control.Engineering support for inspection specifications and non-conforming material reports.Internal engineering projects included software validation and process development, risk management modeling for CAPAs, Design of Experiments, FMEA and data management initiatives for inspection processes. Six Sigma and Process Excellence training/support.



DePuy Synthes

• United States
• Medical Device
• 700 & Above Employee

• Engineer II

  • 2003 - 2006

  Quality and manufacturing process support for spinal implant and arthroscopic design devices. Primary responsibilities included the selection and qualification of external manufacturing vendors for instruments and implant components.Lead author or key contributor of technical validation reports including IQ/OQ/PQ and Process Verification focusing on capability analysis and statistical process control.Engineering support for inspection specifications and non-conforming material reports.Internal engineering projects included software validation and process development, risk management modeling for CAPAs, Design of Experiments, FMEA and data management initiatives for inspection processes. Six Sigma and Process Excellence training/support.