3
Two Tower Place, Suite 800 | South San Francisco CA 94080 1 Senior Clinical Trials Manager Pionyr Immunotherapeutics Inc., a growing South San Francisco-based immuno-oncology company focused on novel approaches to cancer immunotherapy, is seeking an experienced Senior Clinical Trials Manager. The Senior Clinical Trials Manager position will play a key role on the Pionyr Clinical Operations team. Reporting to the Sr. Director, Clinical Operations, the Senior Clinical Trial Manager will be responsible for the implementation of clinical trial activities across one or multiple studies across our development programs. Working closely with investigative site personnel, CROs, and other study vendors and under the direction of the Sr. Director, Clinical Operations, the Senior CTM will drive the conduct of clinical trial activities in accordance with Standard Operating Procedures and all applicable regulations governing the conduct of clinical trials. As a member of our team, you’ll work closely with internal team members and external partners as well as clinical study sites ensuring that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals and budgets. The ideal candidate has proven clinical trials experience within the biotech or related industries preferably with oncology, immunology, or rare disease early development experience, especially management of one or more concurrent studies. To be successful, the incumbent will be a strong collaborator and communicator, possessing outstanding clinical operations skills and a proactive attitude that fits our culture. The position will be based in our South San Francisco office. Specific responsibilities including, but not limited to: Ensuring clinical trials are planned, executed, and monitored in compliance with International Conference on Harmonisation (ICH)/Good Clinical Practices (GCP), including E6R2, local and federal regulations, and applicable Standard Operating Procedures (SOPs) Managing the operational aspects of clinical trials, inclusive of the study project plan, project timeline, budget and resources Participating in protocol, CRF development, Clinical Study Report preparation, and regulatory submissions Preparing metrics and updates for presentation to Pionyrs Senior Management Team (SMT) Organizing and managing internal team meetings, investigator meetings and other trial- specific meetings; Leading the Study Execution Team (SET) for assigned study(ies) Participating in the development, review and implementation of departmental SOPs and processes Recommending and implementing innovative process ideas to positively impact clinical trials management as well as proactively identifying potential study issues/risks and recommending/implementing solutions to the Project Team

but not limited topionyrtx.com/jobs/Senior-Clinical-Trials-Manager-May20.pdf · • Direct management and/or mentoring of junior Clinical Operations team members • Performs other

  • Upload
    others

  • View
    0

  • Download
    0

Embed Size (px)

Citation preview

Page 1: but not limited topionyrtx.com/jobs/Senior-Clinical-Trials-Manager-May20.pdf · • Direct management and/or mentoring of junior Clinical Operations team members • Performs other

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

Page 2: but not limited topionyrtx.com/jobs/Senior-Clinical-Trials-Manager-May20.pdf · • Direct management and/or mentoring of junior Clinical Operations team members • Performs other

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.

Page 3: but not limited topionyrtx.com/jobs/Senior-Clinical-Trials-Manager-May20.pdf · • Direct management and/or mentoring of junior Clinical Operations team members • Performs other

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%.