医学研究经理岗位职责

医学研究经理上海海和药物研究开发有限公司上海海和药物研究开发有限公司,海和药物,海和药物职责描述:

1.developmentstrategyandplan(includingprotocols)forallportfolioprojects;

2.Ensuresuccessfulconductandintegrityofallin-scopeclinicalstudies(i.e.,providingmedicalmonitoring);

3.Co-ownersofclinicalstudydelivery(withStatsandClinicalOperations);

4.Developmentdocuments(CIB,protocolandCSR,ETC)contentowner;

5.AnalysisandinterpretationofclinicalstudyresultsinpartnershipwithBIS,ClinicalOperationsandSafety(aswellasClinicalPharmacologistIfnecessary);

6.Formingandrunningadvisoryboardforportfolioprojects;BeresponsibleforinteractingandcommunicatingwithChinaKOLsforChinadevelopmentstrategyandprotocoldesign;

7.Responsibleforsafetyprogram-levelassessmentofsafetyinformation,evaluationofsafetysignals,regulatorycomplianceofsafetyreporting;

8.OversightofPK/PDprogramsviaclinicalpharmacologisttoensurethedeliverables;

9.LeadingtheteaminprotocoldevelopmentpreparationforreviewbytheClinicalChallengeandProtocolReviewCommittee;

10.Settingstrategicdirectionforaddressingmedicalissuesinregulatorysubmissionandcommunication/interaction;

11.-Collaborateactivelywithcrossfunctionteams,suchasCOD,RA,BD,BDMetc;ProvideclinicalsciencesupporttoBDandChinaprojectsonneededbas.

任职要求:

•Strategicthinking;

•Leadership

•Drugdevelopmentknowledge,ProfoundTherapeuticArea/DiseaseKnowledge

•Professional/technicalskills;

•Interpersonalskillsandteamwork;

•Minimum5-10yearsofclinicaldevelopmentexperienceinpharmaceuticaland/orbiotechindustryorclinicalpracticeasaphysicia;

•Demonstratedleadershipandadministrativeskillsincrossfunctionalprojectteam;

•Bigpicturewithabilitytoprioritizeandfocuswithattentivetodetailandexcellentanalyticalskill;

•Strongand/orextensivenetworkingwithKOLsandinvestigators.