Global Clinical Operation Director (oncology drugs

For insuring clinicalpharmacology support for aportfolio of oncologyprojects. The position will be responsible for leading the clinicalpharmacology function and strategy,in addition to providing clinicalpharmacology expertise to development projects working directly or through staff onmulti-disciplinary teams. Thispositionis akey member of the clinical development teamandresponsible for global regulatory submissions with respect to the clinicalpharmacologypackage. This individual ensures that clinical pharmacology studies areexecutedaccordingtoICH/GCP guidelines, applicable regulatory requirements, and company’s standard operating procedures.

• Responsibleforscientificandbudgetaryresponsibilityfor thedesign,execution,analysis,interpretation and reporting of clinical pharmacology/early phase studiesincluding first-in-human, drug-druginteraction,biopharmaceutics and absorption,distribution,metabolism, and excretion (ADME) studies conductedinhealthysubjects and/or patients.
  
  Responsible for providingpharmacokinetic/pharmacodynamic support to clinical studies across all
• Play akeyrolein clinicalpharmacology functioninIND/NDApreparation activities
• Developandexecuteclinicalpharmacologystrategiesincollaborationwithinternaland external partners to advance drug candidates inanefficientandscientificallyrigorous manner.
• Leadcuttingedgescience,creativityandnovelapproachesinclinicalpharmacologyandrelated areasin addition to providing oversight for work conducted by CROs.
• Represent clinicalpharmacologyin project teams and inregulatoryinteractionsincluding preparation of regulatory documentation andparticipationinmeetings with regulatory agencies.

pharmaceutical sciences orrelated areas such aspharmacokinetics,pharmacologyor drugmetabolism

• 10+ years of relevant experience in drugdevelopmentandglobalregulatory filings
• Extensiveexperienceinformulatingandexecutingclinicaldevelopmentstrategiesincluding design,interpretation and reporting of clinical pharmacology studies is required.
• A working knowledge and previousexperiencewithimmunogenicity,pharmacokinetic/pharmacodynamics, drug-drug interactions,PKPD data andmodelingmanagement/analysis, and experimental medicine is also needed.
• Broad familiarity withthedrugdevelopmentprocess,particularlyforoncology,andprior experience overseeing/working with CROs.
• General knowledge andunderstandingof theclinicaldevelopmentlifecyclefor
  
  PhaseI-III clinical studiesincluding GCPs andICH guidelines
• Experience workingwiththirdpartycontractresearch,development,and/orlaboratory organizations.