Integrated Resources Inc.
Outsourcing Lead
Integrated Resources Inc., La Jolla Ranch, California, United States,
IRI believes in commitment, integrity and strategic workforce solutions.Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.We’ve stayed true to our focus of finding qualified and experienced professionals in our specialty areas. Our partner-employers know that they can rely on us to find the right match between their needs and the abilities of our top-tier candidates. By continually exceeding their expectations, we have built successful ongoing partnerships that help us stay true to our commitments of performance and integrity.Our team works hard to deliver a tailored approach for each and every client, critical in matching the right employers with the right candidates. We forge partnerships that are meant for the long term and align skills and cultures. At IRI, we know that our success is directly tied to our clients’ success.Job Description
Ensure the protection of clinical outsourcing business interestsAccountable to minimize business risk, and maximize research dollars in each contractProvide expert contracts and outsourcing guidance to internal and external stakeholdersAct as a central point of contact for business related issues and facilitate conflict resolutionLeads and manages cost estimate processes for high level scenario planningLeads study, program, and asset level outsourcing cost analysis effortsSituational outsourcing consultation and guidanceDirectly negotiates business terms, clinical operations fees, and scope of services with Alliance Partners (AP's), CRO's and other service providersProvides leadership and oversight in one or more key areas within outsourcing (i.e. PSC Development, FCPA Process, etc.)Embrace and drive forward the current outsourcing model with AP’s & selected service providers.Responsibilities:To meet client business needs, assess and apply innovative outsourcing solutions harmonized with Pfizer’s unique and specialized partner facing modelUnderstands and utilizes novel project planning and costing tools/software to evaluate options, negotiate costs and recommend optimal value-added solutions for APs / Preferred SuppliersLiaises frequently with customers and stakeholders to ensure they have realistic expectations of the contracting process, external providers and the contracting environmentProvides expertise to study teams by identifying and evaluating available outsourcing and resourcing options to facilitate optimal decision-making at a global and local levelManages the outsourcing process as an agent of Business Operations:In collaboration with study teams, gains an in-depth understanding of study requirements in order to secure appropriate level and type of resources and services from Contract Research Organizations (CROs) and other service providers -identifies and brokers appropriate study execution options -requests proposals from AP's & other service providers -analyzes and negotiates complex proposals and provides recommendations and analysis to study teams for decision making -selects vendors in collaboration with study teams -negotiates contracts related to services totalling in the millions of dollars within the agreed legal and budgetary process frameworkResponsible for the preparation of Request for ProposalsResponsible for the preparation, negotiation and finalization/execution of full-service Alliance Partner Work Orders, 3rd party Vendor Services Agreements, Investigator Initiated Research Agreements, Outcomes Research Agreements, Publications Agreements, Change Orders, Consultant Agreements, Master Services Agreements, Clinical Research Agreements and other types of ad-hoc agreementsDirectly negotiates proposed changes to standard contract language within guidelines provided by the Legal Division; raises significant requested changes to standard contract language to the Legal Division and significant budget exceptions to the appropriate stakeholders for resolutionDesigns creative and risk-averse payment schedules in order to drive vendor performance, protect financial interests and comply with Sarbane-Oxley, Generally Accepted Accounting Principles and other regulationsOversees Per Subject Cost estimation and Clinical Study Agreements executionCommunicates impact of significant contractual changes and associated budgets to BUs/RUs and other stakeholders proactively to ensure funding availabilityWorks with BUs/RUs to analyze service provider forecasted budgets to ensure appropriate and acceptable costs for services are presented by providersProvides oversight and leadership as a subject matter expert in one or more key areas of outsourcing expertise, and participates in special projects as needed in support of the OWN IT cultureIdentifies process gaps. Works with Business Operations Outsourcing Group Lead to drive the creation and implementation of contracting and outsourcing tools to best fill such gaps and support the businessResponsible for obtaining ‘real time’ external knowledge, expertise, feasibility data (supplier surveillance) and assessment of external commercial market place.Participates on critical, highly visible, global initiatives, within and outside of Dev-Ops, contributing value-added sourcing, contracting and budgetary related expertiseQualifications
BA or BS degree and/or recognized amount of work experience (preferably in a related discipline)An advanced degree (MBA, JD, etc.), prior management responsibilities, and/or substantial work experience is preferential for the Director Level (P05)Clinical trials Sponsor experience, CRO operational and/or BD experience, or other trial related experience, including significant experience negotiating and drafting clinical trial-related agreements is requiredExcellent oral/written communication skills and proficiency with MS Office applications (Word/PPT/Excel) required: experience with ACW, ClearTrial, Grants Manager and / or other industry cost and planning tools preferredFairly high level position.Finance/Clinical Budgeting experienceDemonstrates clear understanding of activity based costs along study path; additionally, Director Level (P05) demonstrates expertise in strategic cost relationships and links (program, asset, portfolio, etc.) for planning and forecasting, negotiation, and higher level presentationUnderstands components of clinical & per subject costing & use of industry benchmarkingOperational expertise in study scheduling and placement Knowledge of clinical study outsourcing; Director Level (P05) requires expert knowledge in clinical trial development outsourcingUnderstanding of operational impact to timelines, budget, and quality desired, and required for Director Level (P05)Knowledge and experience of contracting with external service providersApplication of contracting strategies at enterprise levelsInternal and external influencing abilities for expectation and timeline management; for Director Level (P05), proven experience requiredIdentifies and leads efforts to examine multiple solutions or innovative options in solving highly complex problems directly impacting a Global Business Unit/Global Operating Unit or Sub Business Unit/Sub Operating Unit
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Ensure the protection of clinical outsourcing business interestsAccountable to minimize business risk, and maximize research dollars in each contractProvide expert contracts and outsourcing guidance to internal and external stakeholdersAct as a central point of contact for business related issues and facilitate conflict resolutionLeads and manages cost estimate processes for high level scenario planningLeads study, program, and asset level outsourcing cost analysis effortsSituational outsourcing consultation and guidanceDirectly negotiates business terms, clinical operations fees, and scope of services with Alliance Partners (AP's), CRO's and other service providersProvides leadership and oversight in one or more key areas within outsourcing (i.e. PSC Development, FCPA Process, etc.)Embrace and drive forward the current outsourcing model with AP’s & selected service providers.Responsibilities:To meet client business needs, assess and apply innovative outsourcing solutions harmonized with Pfizer’s unique and specialized partner facing modelUnderstands and utilizes novel project planning and costing tools/software to evaluate options, negotiate costs and recommend optimal value-added solutions for APs / Preferred SuppliersLiaises frequently with customers and stakeholders to ensure they have realistic expectations of the contracting process, external providers and the contracting environmentProvides expertise to study teams by identifying and evaluating available outsourcing and resourcing options to facilitate optimal decision-making at a global and local levelManages the outsourcing process as an agent of Business Operations:In collaboration with study teams, gains an in-depth understanding of study requirements in order to secure appropriate level and type of resources and services from Contract Research Organizations (CROs) and other service providers -identifies and brokers appropriate study execution options -requests proposals from AP's & other service providers -analyzes and negotiates complex proposals and provides recommendations and analysis to study teams for decision making -selects vendors in collaboration with study teams -negotiates contracts related to services totalling in the millions of dollars within the agreed legal and budgetary process frameworkResponsible for the preparation of Request for ProposalsResponsible for the preparation, negotiation and finalization/execution of full-service Alliance Partner Work Orders, 3rd party Vendor Services Agreements, Investigator Initiated Research Agreements, Outcomes Research Agreements, Publications Agreements, Change Orders, Consultant Agreements, Master Services Agreements, Clinical Research Agreements and other types of ad-hoc agreementsDirectly negotiates proposed changes to standard contract language within guidelines provided by the Legal Division; raises significant requested changes to standard contract language to the Legal Division and significant budget exceptions to the appropriate stakeholders for resolutionDesigns creative and risk-averse payment schedules in order to drive vendor performance, protect financial interests and comply with Sarbane-Oxley, Generally Accepted Accounting Principles and other regulationsOversees Per Subject Cost estimation and Clinical Study Agreements executionCommunicates impact of significant contractual changes and associated budgets to BUs/RUs and other stakeholders proactively to ensure funding availabilityWorks with BUs/RUs to analyze service provider forecasted budgets to ensure appropriate and acceptable costs for services are presented by providersProvides oversight and leadership as a subject matter expert in one or more key areas of outsourcing expertise, and participates in special projects as needed in support of the OWN IT cultureIdentifies process gaps. Works with Business Operations Outsourcing Group Lead to drive the creation and implementation of contracting and outsourcing tools to best fill such gaps and support the businessResponsible for obtaining ‘real time’ external knowledge, expertise, feasibility data (supplier surveillance) and assessment of external commercial market place.Participates on critical, highly visible, global initiatives, within and outside of Dev-Ops, contributing value-added sourcing, contracting and budgetary related expertiseQualifications
BA or BS degree and/or recognized amount of work experience (preferably in a related discipline)An advanced degree (MBA, JD, etc.), prior management responsibilities, and/or substantial work experience is preferential for the Director Level (P05)Clinical trials Sponsor experience, CRO operational and/or BD experience, or other trial related experience, including significant experience negotiating and drafting clinical trial-related agreements is requiredExcellent oral/written communication skills and proficiency with MS Office applications (Word/PPT/Excel) required: experience with ACW, ClearTrial, Grants Manager and / or other industry cost and planning tools preferredFairly high level position.Finance/Clinical Budgeting experienceDemonstrates clear understanding of activity based costs along study path; additionally, Director Level (P05) demonstrates expertise in strategic cost relationships and links (program, asset, portfolio, etc.) for planning and forecasting, negotiation, and higher level presentationUnderstands components of clinical & per subject costing & use of industry benchmarkingOperational expertise in study scheduling and placement Knowledge of clinical study outsourcing; Director Level (P05) requires expert knowledge in clinical trial development outsourcingUnderstanding of operational impact to timelines, budget, and quality desired, and required for Director Level (P05)Knowledge and experience of contracting with external service providersApplication of contracting strategies at enterprise levelsInternal and external influencing abilities for expectation and timeline management; for Director Level (P05), proven experience requiredIdentifies and leads efforts to examine multiple solutions or innovative options in solving highly complex problems directly impacting a Global Business Unit/Global Operating Unit or Sub Business Unit/Sub Operating Unit
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