but not limited topionyrtx.com/jobs/senior-clinical-trials-manager-may20.pdf · • direct...

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%.