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Two Tower Place, Suite 800 | South San Francisco CA 94080 1
SeniorClinicalTrialsManagerPionyrImmunotherapeuticsInc.,agrowingSouthSanFrancisco-basedimmuno-oncologycompanyfocusedonnovelapproachestocancerimmunotherapy,isseekinganexperiencedSeniorClinicalTrialsManager.TheSeniorClinicalTrialsManagerpositionwillplayakeyroleonthePionyrClinicalOperationsteam.ReportingtotheSr.Director,ClinicalOperations,theSeniorClinicalTrialManagerwillberesponsiblefortheimplementationofclinicaltrialactivitiesacrossoneormultiplestudiesacrossourdevelopmentprograms.Workingcloselywithinvestigativesitepersonnel,CROs,andotherstudyvendorsandunderthedirectionoftheSr.Director,ClinicalOperations,theSeniorCTMwilldrivetheconductofclinicaltrialactivitiesinaccordancewithStandardOperatingProceduresandallapplicableregulationsgoverningtheconductofclinicaltrials.Asamemberofourteam,you’llworkcloselywithinternalteammembersandexternalpartnersaswellasclinicalstudysitesensuringthatclinicaltrialsareconductedinatimelyfashionandinamannercompliantwithSOPs,ICH/GCP/regulatoryguidelines,companygoalsandbudgets.Theidealcandidatehasprovenclinicaltrialsexperiencewithinthebiotechorrelatedindustriespreferablywithoncology,immunology,orrarediseaseearlydevelopmentexperience,especiallymanagementofoneormoreconcurrentstudies.Tobesuccessful,theincumbentwillbeastrongcollaboratorandcommunicator,possessingoutstandingclinicaloperationsskillsandaproactiveattitudethatfitsourculture.ThepositionwillbebasedinourSouthSanFranciscooffice.Specificresponsibilitiesincluding,butnotlimitedto:
• Ensuringclinicaltrialsareplanned,executed,andmonitoredincompliancewithInternationalConferenceonHarmonisation(ICH)/GoodClinicalPractices(GCP),includingE6R2,localandfederalregulations,andapplicableStandardOperatingProcedures(SOPs)
• Managingtheoperationalaspectsofclinicaltrials,inclusiveofthestudyprojectplan,projecttimeline,budgetandresources
• Participatinginprotocol,CRFdevelopment,ClinicalStudyReportpreparation,andregulatorysubmissions
• PreparingmetricsandupdatesforpresentationtoPionyr’sSeniorManagementTeam(SMT)• Organizingandmanaginginternalteammeetings,investigatormeetingsandothertrial-
specificmeetings;LeadingtheStudyExecutionTeam(SET)forassignedstudy(ies)• Participatinginthedevelopment,reviewandimplementationofdepartmentalSOPsand
processes• Recommendingandimplementinginnovativeprocessideastopositivelyimpactclinicaltrials
managementaswellasproactivelyidentifyingpotentialstudyissues/risksandrecommending/implementingsolutionstotheProjectTeam
Two Tower Place, Suite 800 | South San Francisco CA 94080 2
• Maintainingoperationaltrackingandreportsinsupportofprogramand/ordepartmentalactivities(e.g.,DecisionLog,MonitoringVisitReportReviewLog,ClinicalOperationsAgreementTracker,SOPTracker,etc.)
• InteractswiththestudyMedicalDirectorandmembersofthecross-functionalstudyteam,asneeded;interactsfrequentlywithcross-functionalinternalandexternalpersonnel(eg,Regulato-ryAffairs,investigators,vendors)
• Coordinatingandassistingintheplanningofregulatoryorethicscommitteeactivities,asappropriate
• Directmanagementand/ormentoringofjuniorClinicalOperationsteammembers• Performsothertasksassignedtopromotetheefficientmanagement/oversightoftheclinical
trial(s)
CRO/vendormanagementactivitiesincluding:
• ParticipatinginandfacilitatingtheCRO/vendorselectionprocessforoutsourcedactivities• ManagingCROinteractionsincludingsponsoroversightofoperationalfunctionalactivities
(studymanagement,monitoring,sitemanagement,trialmasterfilesanddocumentation)• WorkingwiththeCROtodevelopandrevisescopeofserviceagreements,budgets,plans,
anddetailedtimelinesensuringthatperformanceexpectationsaremet• Preparing,reviewing,andapprovingstudy-relateddocuments(e.g.,MonitoringPlan,
LaboratoryManual,StudyReferenceManual,PharmacyManualandCRFCompletionGuidelines)
• Participatingintheselection,training,andevaluationofclinicalsites• ServingasaliaisonandresourceforCROs,vendorsandinvestigationalsites• Preparing,reviewing,approvingsitestudydocumentsandtemplates,(informedconsent
templateandstudytools/worksheets),investigatorcontracts,andsitepayments• Participatinginsitemonitoringormonitoringoversightvisits,asappropriate.• Supportingqualityassuranceactivitiesbycoordinatingresolutionofauditfindingsand
CorrectiveandPreventativeActionPlans(CAPAs);ensuringaudit-readyconditionofclinicaltrialdocumentationincludingtheTMF;reviewingmonitoringvisitreportstoensurequalityandresolutionofsite-relatedissues
Requirements
• Bachelor’sDegreewith8+yearsofclinicalresearchexperiencepreferablywithinoncology,immunologyorrarediseases.
• KnowledgeofICHGCPguidelinesandregulatoryrequirementsforclinicaltrialmanagement;Strongclinicalstudymanagementskills.
• Understandingof,andexperiencewith,regulatoryframeworkapplicabletointeractionswithHCPs,payers,advocacyandotherbusinesspartners.
• Provenleadershipskillstodirectprotocolexecutiontoensuretimeline,budgetandqualitymet-ricsaremet.
Two Tower Place, Suite 800 | South San Francisco CA 94080 3
• Excellentcommunicationskillstoeffectivelydisseminateinformationtoprojectteamandout-sideparties.
• Experiencedevelopingtrialplansincludingdevelopingcreativestrategiesforsitemonitoring,riskmitigation,trialbudgets,siteselection,andclinicalsuppliesmanagement.
• Extensiveclinicalresearchknowledgeandcross-functionalunderstandingofclinicaltrialmeth-odology.
• Excellentorganizational,conflictresolution,prioritizationandnegotiationskills.Provenabilityincreativeproblem-solvingandexercisingsoundjudgment.
• Teamorientedandabilitytoeffectivelycollaboratewithstudyteam,cross-functionalteammembers,andexternalpartners.
• Abilitytohandleahighvolumeofhighlycomplextaskswithinagiventimeline.• AbilitytodevelopTherapeuticAreaknowledgeandexpertisethroughinternaltrainingandex-
ternalconferenceattendance.• Proficientcomputerskills,specificallywithMicrosoftOfficeSuitethatincludeWord,Excel,Pow-
erPoint,andOutlook;strongknowledgeofMSProjectformanagementoftrialtimelines.• Willingtotravel–anticipate25%.