Experience

Halloran Consulting Group, Inc.

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

• Consultant

  • Feb 2015 - Present

  • Provide regulatory strategic development planning and support with focus on emerging life sciences companies pursuing early stage to late stage development • Interact with Regulatory Agencies on behalf of clients • Develop and manage strategic content of FDA Meeting materials, and special designation pathways for projects across multiple FDA Divisions • Effectively manage assigned projects and regulatory submissions including regulatory operations oversight • Create and manage… Show more • Provide regulatory strategic development planning and support with focus on emerging life sciences companies pursuing early stage to late stage development • Interact with Regulatory Agencies on behalf of clients • Develop and manage strategic content of FDA Meeting materials, and special designation pathways for projects across multiple FDA Divisions • Effectively manage assigned projects and regulatory submissions including regulatory operations oversight • Create and manage regulatory tracking documents, regulatory plans, correspondence logs and timelines Show less • Provide regulatory strategic development planning and support with focus on emerging life sciences companies pursuing early stage to late stage development • Interact with Regulatory Agencies on behalf of clients • Develop and manage strategic content of FDA Meeting materials, and special designation pathways for projects across multiple FDA Divisions • Effectively manage assigned projects and regulatory submissions including regulatory operations oversight • Create and manage… Show more • Provide regulatory strategic development planning and support with focus on emerging life sciences companies pursuing early stage to late stage development • Interact with Regulatory Agencies on behalf of clients • Develop and manage strategic content of FDA Meeting materials, and special designation pathways for projects across multiple FDA Divisions • Effectively manage assigned projects and regulatory submissions including regulatory operations oversight • Create and manage regulatory tracking documents, regulatory plans, correspondence logs and timelines Show less



Agenus

• United States
• Biotechnology Research
• 200 - 300 Employee

• Senior Regulatory Affairs Associate

  • Feb 2010 - Mar 2015

  • Prepared regulatory submissions to FDA for all active INDs including annual reports, protocol amendments, new investigator information, CMC changes and all general correspondence • Prepared and submitted annual reports within specified timeframe by obtaining and reviewing all necessary information from various departments including clinical, manufacturing, data management, quality and safety • Prepared and submitted annual reports to FDA and EMA for several orphan drug… Show more • Prepared regulatory submissions to FDA for all active INDs including annual reports, protocol amendments, new investigator information, CMC changes and all general correspondence • Prepared and submitted annual reports within specified timeframe by obtaining and reviewing all necessary information from various departments including clinical, manufacturing, data management, quality and safety • Prepared and submitted annual reports to FDA and EMA for several orphan drug designations • Reviewed all internal documents for regulatory compliance including standard operating procedures, item specifications, batch records, standard test methods and labeling • Reviewed clinical documents including protocols, amendments and informed consent forms • Assisted Quality Assurance Department in completing internal audits • Prepared Periodic Benefit-Risk Evaluation Report (PBRER) and Company Core Data Sheet for submission to Russian Authorities Show less • Prepared regulatory submissions to FDA for all active INDs including annual reports, protocol amendments, new investigator information, CMC changes and all general correspondence • Prepared and submitted annual reports within specified timeframe by obtaining and reviewing all necessary information from various departments including clinical, manufacturing, data management, quality and safety • Prepared and submitted annual reports to FDA and EMA for several orphan drug… Show more • Prepared regulatory submissions to FDA for all active INDs including annual reports, protocol amendments, new investigator information, CMC changes and all general correspondence • Prepared and submitted annual reports within specified timeframe by obtaining and reviewing all necessary information from various departments including clinical, manufacturing, data management, quality and safety • Prepared and submitted annual reports to FDA and EMA for several orphan drug designations • Reviewed all internal documents for regulatory compliance including standard operating procedures, item specifications, batch records, standard test methods and labeling • Reviewed clinical documents including protocols, amendments and informed consent forms • Assisted Quality Assurance Department in completing internal audits • Prepared Periodic Benefit-Risk Evaluation Report (PBRER) and Company Core Data Sheet for submission to Russian Authorities Show less



Antigenics

• Biotechnology Research
• 1 - 100 Employee

• Associate Director of Laboratory Animal Science; Animal Facility Manager, Research Associate

  • Mar 1998 - Feb 2010

  • Designed, scheduled and monitored all in-house pre-clinical animal studies • Managed Laboratory Animal Science department personnel • Created and managed annual budget for Laboratory Animal Science Department • Wrote animal protocols for various projects and served as study director on most protocols • Responsible for start-up, validation, and maintenance of new animal facility within USDA and GLP guidelines • Wrote Standard Operating Procedures for animal facility maintenance,… Show more • Designed, scheduled and monitored all in-house pre-clinical animal studies • Managed Laboratory Animal Science department personnel • Created and managed annual budget for Laboratory Animal Science Department • Wrote animal protocols for various projects and served as study director on most protocols • Responsible for start-up, validation, and maintenance of new animal facility within USDA and GLP guidelines • Wrote Standard Operating Procedures for animal facility maintenance, equipment use, and technical procedures • Managed and coordinated IACUC activities as IACUC Chairperson • Monitored pre-clinical work performed at contract laboratories • Wrote technical reports summarizing results of various animal studies • Developed departmental goals and project timelines • Developed animal models in areas of oncology, infectious disease and autoimmunity • Performed oncology studies utilizing numerous mouse tumor models and xenograft models • Performed HSV-2 infectious disease animal studies in mice and guinea pigs • Performed autoimmune studies utilizing models of rheumatoid arthritis, diabetes and EAE • Performed technical procedures including injections (ID, SC, IP, IV), tumor measurements, clinical scoring, blood collections, surgical procedures, necropsy procedures, tissue culture • AALAS Laboratory Animal Technologist (LATG) certified and Certified Manager of Animal Resources (CMAR) Show less • Designed, scheduled and monitored all in-house pre-clinical animal studies • Managed Laboratory Animal Science department personnel • Created and managed annual budget for Laboratory Animal Science Department • Wrote animal protocols for various projects and served as study director on most protocols • Responsible for start-up, validation, and maintenance of new animal facility within USDA and GLP guidelines • Wrote Standard Operating Procedures for animal facility maintenance,… Show more • Designed, scheduled and monitored all in-house pre-clinical animal studies • Managed Laboratory Animal Science department personnel • Created and managed annual budget for Laboratory Animal Science Department • Wrote animal protocols for various projects and served as study director on most protocols • Responsible for start-up, validation, and maintenance of new animal facility within USDA and GLP guidelines • Wrote Standard Operating Procedures for animal facility maintenance, equipment use, and technical procedures • Managed and coordinated IACUC activities as IACUC Chairperson • Monitored pre-clinical work performed at contract laboratories • Wrote technical reports summarizing results of various animal studies • Developed departmental goals and project timelines • Developed animal models in areas of oncology, infectious disease and autoimmunity • Performed oncology studies utilizing numerous mouse tumor models and xenograft models • Performed HSV-2 infectious disease animal studies in mice and guinea pigs • Performed autoimmune studies utilizing models of rheumatoid arthritis, diabetes and EAE • Performed technical procedures including injections (ID, SC, IP, IV), tumor measurements, clinical scoring, blood collections, surgical procedures, necropsy procedures, tissue culture • AALAS Laboratory Animal Technologist (LATG) certified and Certified Manager of Animal Resources (CMAR) Show less



MTRA

• Natick, MA

• Clinical Data Analyst

  • Feb 1997 - Mar 1998

  • Conducted safety review of data from Phase II, III, and IV clinical studies. • Performed coding of data for reporting purposes using WHO, ICD-9 and project specific dictionaries • Wrote case report form completion guidelines for use by monitors, coordinators, and investigators • Presented case report form completion guidelines at international study initiation meetings • Communicated with client, program manager and operational staff on project status • Utilized Remote Data… Show more • Conducted safety review of data from Phase II, III, and IV clinical studies. • Performed coding of data for reporting purposes using WHO, ICD-9 and project specific dictionaries • Wrote case report form completion guidelines for use by monitors, coordinators, and investigators • Presented case report form completion guidelines at international study initiation meetings • Communicated with client, program manager and operational staff on project status • Utilized Remote Data Entry systems for review of data and communication with sites on project issues and questions Show less • Conducted safety review of data from Phase II, III, and IV clinical studies. • Performed coding of data for reporting purposes using WHO, ICD-9 and project specific dictionaries • Wrote case report form completion guidelines for use by monitors, coordinators, and investigators • Presented case report form completion guidelines at international study initiation meetings • Communicated with client, program manager and operational staff on project status • Utilized Remote Data… Show more • Conducted safety review of data from Phase II, III, and IV clinical studies. • Performed coding of data for reporting purposes using WHO, ICD-9 and project specific dictionaries • Wrote case report form completion guidelines for use by monitors, coordinators, and investigators • Presented case report form completion guidelines at international study initiation meetings • Communicated with client, program manager and operational staff on project status • Utilized Remote Data Entry systems for review of data and communication with sites on project issues and questions Show less



Charles River Laboratories

• United States
• Biotechnology Research
• 700 & Above Employee

• Laboratory Technician; Scientific Systems Administrator; Study Coordinator

  • Jun 1992 - Feb 1997

  Study Coordinator, Toxicology 1996-1997 • Organized, conducted and monitored specific projects • Conducted review of data to ensure compliance with GLP standards • Interpreted data and prepared interim and final reports for submission to clients • Coordinated animal orders, study timelines, and operational staff for specific projects • Communicated with operational staff, study director and client on study status • Responded to Quality Assurance… Show more Study Coordinator, Toxicology 1996-1997 • Organized, conducted and monitored specific projects • Conducted review of data to ensure compliance with GLP standards • Interpreted data and prepared interim and final reports for submission to clients • Coordinated animal orders, study timelines, and operational staff for specific projects • Communicated with operational staff, study director and client on study status • Responded to Quality Assurance audits • Designed protocols and protocol amendments Scientific Systems Administrator, Data Administration 1995 – 1996 • Performed technical evaluation, assessment, and analysis of study protocols to determine appropriate departmental requirements for statistical and data interpretation • Designed and generated data collection forms on a protocol specific basis • Generated reports for data interpretation for study directors, clients, and the study report • Instructed and assisted users with software, data entry, and hardware problems for automated data capture systems Laboratory Technician, Anatomical Pathology 1992 – 1995 • Performed necropsy on animal species including rodents, dogs, small ruminants, and non-human primates • Collaborated with veterinary pathologists to make diagnostic conclusions • Prepared specific tissue sections for histological evaluation • Trained new employees Show less Study Coordinator, Toxicology 1996-1997 • Organized, conducted and monitored specific projects • Conducted review of data to ensure compliance with GLP standards • Interpreted data and prepared interim and final reports for submission to clients • Coordinated animal orders, study timelines, and operational staff for specific projects • Communicated with operational staff, study director and client on study status • Responded to Quality Assurance… Show more Study Coordinator, Toxicology 1996-1997 • Organized, conducted and monitored specific projects • Conducted review of data to ensure compliance with GLP standards • Interpreted data and prepared interim and final reports for submission to clients • Coordinated animal orders, study timelines, and operational staff for specific projects • Communicated with operational staff, study director and client on study status • Responded to Quality Assurance audits • Designed protocols and protocol amendments Scientific Systems Administrator, Data Administration 1995 – 1996 • Performed technical evaluation, assessment, and analysis of study protocols to determine appropriate departmental requirements for statistical and data interpretation • Designed and generated data collection forms on a protocol specific basis • Generated reports for data interpretation for study directors, clients, and the study report • Instructed and assisted users with software, data entry, and hardware problems for automated data capture systems Laboratory Technician, Anatomical Pathology 1992 – 1995 • Performed necropsy on animal species including rodents, dogs, small ruminants, and non-human primates • Collaborated with veterinary pathologists to make diagnostic conclusions • Prepared specific tissue sections for histological evaluation • Trained new employees Show less