James Toler Email & Phone Number

United States

Cambridge, Massachusetts, United States

West Point, Pa

● Manage / lead communications with external vendors for pre-clinical safety organization● Identify best CRO for outsourced studies and award studies while securing best pricing and scheduling● Lead issue resolution discussions when occasions arise ● Liase with internal finance group to determine best pricing and payment scheduling strategy for CRO’s, then communicate strategy to CRO for implementation● Process SOW’s for newly awarded studies and amendments and authorize… Show more ● Manage / lead communications with external vendors for pre-clinical safety organization● Identify best CRO for outsourced studies and award studies while securing best pricing and scheduling● Lead issue resolution discussions when occasions arise ● Liase with internal finance group to determine best pricing and payment scheduling strategy for CRO’s, then communicate strategy to CRO for implementation● Process SOW’s for newly awarded studies and amendments and authorize payments as invoices are received●Maintain spreadsheet of ongoing studies and date deliverables●Set strategy for future outsourcing growth and roll out changes to organization in a timely manner●Travel to CRO’s to monitor ongoing studies and to meet with Site Leadership to maintain open communications Show less

Cambridge Ma

Wave Life Sciences, Cambridge MA Jan 2017 to PresentAssociate Director Non Clinical Outsourcing for Drug Safety (Nov. 2017 to Present)• Create and manage outsourcing strategy for Non-Clinical toxicology studies. Identify and qualify new CRO Labs and negotiate cost savings partner strategies with select vendors.● Provide oversight management of Preclinical Outsourced Projects including study scheduling, CRO lab selection/qualification, study monitoring, reporting… Show more Wave Life Sciences, Cambridge MA Jan 2017 to PresentAssociate Director Non Clinical Outsourcing for Drug Safety (Nov. 2017 to Present)• Create and manage outsourcing strategy for Non-Clinical toxicology studies. Identify and qualify new CRO Labs and negotiate cost savings partner strategies with select vendors.● Provide oversight management of Preclinical Outsourced Projects including study scheduling, CRO lab selection/qualification, study monitoring, reporting, initiating project work-orders/contracts, negotiating costs, deliverable timing and budget forecasting● Manage outsource study/project budgets with CRO as agreed and prior to study/project initiation, partnering with WRD Scientists/Scientific Technical Representatives (STR) to monitor project related invoices and accurate timely payment through maintenance and communication of accurate information on study conduct milestones and activities● Lead CRO site qualification teams to inspect and qualify CROs for support of preclinical studies● Manage the development and tracking of CRO performance metrics to identifybest practices and gaps ● Manage the relationship with CRO project scientists to ensure studies conducted at CROs address the scientific requirements specified and assure that Clinical Document Architecture (CDA) is properly supported with Continuity of Care Record (CRRC) and Continuity of Care Document (CCD) data table reports that are suitable for regulatory submission● Build strong partnerships with CROs, WAVE Scientists, RQA, and other partner lines to ensure projects are conducted within required regulatory/quality guidelines ● Ensure appropriate level of communication between WAVE Scientists/STR and CRO Scientists● Review/update and enforce CRO compliance of WAVE Master Service Agreements (MSA) Show less

Cambridge, Ma

PROFESSIONAL EXPERIENCEWave Life Sciences, Cambridge MA Associate Director Outsourcing (Nov 2016 to Present)• Create and manage innovative outsourcing strategy for Pre-Clinical toxicology and Clinical Bioanalytical studies. Identify and qualify new CRO Labs and negotiate cost savings partner strategies with select vendors.• Manage a group of 4 FTE’s that support outsourcing programs for Safety Toxicology, Bioanalytical testing and Exploratory studies.• Provide… Show more PROFESSIONAL EXPERIENCEWave Life Sciences, Cambridge MA Associate Director Outsourcing (Nov 2016 to Present)• Create and manage innovative outsourcing strategy for Pre-Clinical toxicology and Clinical Bioanalytical studies. Identify and qualify new CRO Labs and negotiate cost savings partner strategies with select vendors.• Manage a group of 4 FTE’s that support outsourcing programs for Safety Toxicology, Bioanalytical testing and Exploratory studies.• Provide oversight management of Preclinical/ Clinical Outsourced Projects including study scheduling, CRO lab selection/qualification, study monitoring, reporting, initiating project work and issue resolution. orders/contracts (Statement of Work - SOW), negotiating costs, preferred pricing, deliverable timing, budget forecasting and issue resolution and managing Wave Life Science dedicated FTE pool of employees at CRO’s.• Manage outsource study/project budgets with CRO as agreed and prior to study/project initiation, partnering with WRD Scientists/Scientific Technical Representatives (STR) to monitor project related invoices and accurate timely payment through maintenance and communication of accurate information on study conduct milestones and activitiesLead CRO site qualification teams to inspect and qualify CROs for support of preclinical studies• Manage the development and tracking of CRO performance metrics to identify best practices and gaps. Manage the relationship with CRO project scientists to ensure studies conducted at CROs address the scientific requirements specified and assure that Clinical Document Architecture (CDA) is properly supported with Continuity of Care Record (CRRC) and Continuity of Care Document (CCD) data table reports that are suitable for regulatory submission Show less

Saint Louis, Missouri

Outsourcing Professional In-vivo Toxicology Project Manager (Aug 2007 to Present)● Provide management of DSRD Outsourced Projects including study scheduling,monitoring, reporting, initiating project work-orders/contracts, negotiating costs and timing ● Manage outsource study/project budgets with CRO as agreed prior to study/project initiation, partnering with DSRD Scientists/Scientific Technical Representatives (STR) to monitor project related invoices and accurate, timely payment… Show more Outsourcing Professional In-vivo Toxicology Project Manager (Aug 2007 to Present)● Provide management of DSRD Outsourced Projects including study scheduling,monitoring, reporting, initiating project work-orders/contracts, negotiating costs and timing ● Manage outsource study/project budgets with CRO as agreed prior to study/project initiation, partnering with DSRD Scientists/Scientific Technical Representatives (STR) to monitor project related invoices and accurate, timely payment through maintenance and communication of accurate information on study conduct milestones and activities ● Participate on CRO qualification teams to inspect and validate CROs for use in the conduct of DSRD studies ● Participate in the development and tracking of CRO performance metrics to identify best practices and gaps ● Provides input/feedback to DSRD Scientists, other Outsourcing Professionals and CRO staff on best practices and opportunities for improving activities and relationships ● Partner with DSRD and CRO project scientists to ensure studies conducted at CROs address the scientific requirements specified, and that the resulting reports are suitable for regulatory submission, delivered on time and within budget ● Build strong partnerships with CROs, DSRD Scientists, RQA, and other Pfizer partner lines to ensure projects are conducted within required regulatory/quality guidelines ● Ensure appropriate level of communication between DSRD Scientists/STR and CRO Scientists Show less

Responsible for the daily operations and compliance of the Toxicology Operations division. Other duties include pursuing innovative advances in operations as part of a project management team. •Acting as liaison between Study Coordinators, Study Directors and the Pfizer Leadership Team.•Provide leadership and mentoring, husbandry duties, direct team projects, manage training programs, and maintain budgetary matters for the Toxicology group.•Responsible for managing the daily… Show more Responsible for the daily operations and compliance of the Toxicology Operations division. Other duties include pursuing innovative advances in operations as part of a project management team. •Acting as liaison between Study Coordinators, Study Directors and the Pfizer Leadership Team.•Provide leadership and mentoring, husbandry duties, direct team projects, manage training programs, and maintain budgetary matters for the Toxicology group.•Responsible for managing the daily activities of nine employees performing pharmacokinetic/metabolic studies, and husbandry duties in various animal models under cGMP/GLP conditions.•Training coordinator for all computer based activities utilized in the toxicology area.•Represent the Pfizer Toxicology division in inspections conducted by the FDA, USDA and DEA.•Responsible for monthly review and updating of operational SOP’s.. Show less

Responsible for staffing and management within the Small Animal Toxicology organization. Other duties included interviewing of potential employees at all levels in addition to representing the company in human resource issues as needed. •Provided leadership and mentoring, managed training program, directed projects, and maintained budgetary matters for the Small Animal Toxicology group.•Ensured customer protocols were followed in all testing and husbandry procedures and completed within… Show more Responsible for staffing and management within the Small Animal Toxicology organization. Other duties included interviewing of potential employees at all levels in addition to representing the company in human resource issues as needed. •Provided leadership and mentoring, managed training program, directed projects, and maintained budgetary matters for the Small Animal Toxicology group.•Ensured customer protocols were followed in all testing and husbandry procedures and completed within required time.•Reviewed all data for completeness and accuracy before submission to Study Director.•Ensured all safety, cGMP, and SOP procedures were enforced and adhered to.•Led a team comprised of 3 Project Supervisors and 37 technicians of various levels.•Developed novel feeder system to eliminate food spillage during consumption studies. (submitted for publication in Lab Animal June 2001) Show less

Scientist, Pharmaceutical Manufacturing Group (1995-2000)Led a team of personnel responsible for final product packaging of novel radioactive diagnostic/therapeutic agents.•Packaged and assembled ion-exchange columns to be used in the manufacture of TC99m generators.•Produced, at large scale, solutions for the manufacture of various radiopharmaceuticals.•Manufactured final products in sterile facility, under cGMP requirements.•Performed inventory control using Just In Time… Show more Scientist, Pharmaceutical Manufacturing Group (1995-2000)Led a team of personnel responsible for final product packaging of novel radioactive diagnostic/therapeutic agents.•Packaged and assembled ion-exchange columns to be used in the manufacture of TC99m generators.•Produced, at large scale, solutions for the manufacture of various radiopharmaceuticals.•Manufactured final products in sterile facility, under cGMP requirements.•Performed inventory control using Just In Time and various DuPont systems.•Adhered to USDA, FDA, NRC and OSHA regulations.•Validated new assembly units for solution storage vessels.•Operated sterilizers, depyronizing ovens (Hot Pack), drying ovens, Metromatic and Capsolute washers. Operated and performed troubleshooting of Neuman labeling machine.. Show less