Clinical Research Medical Advisor - FSP

Job Summary

• Accountableforallcountryclinical/medicalaspectsassociatedwithDevelopmentandprioritizedRe-search programs/trialsbyprovidingclinicalstrategicandtacticalleadershipastheCountryClinicalDevelopment representative. May work across several countries.

• Gathers,informs,andactsonclinical/medical/scientificinsightsforclinicaltrialconceptsheets/protocols, InformedConsentForms(ICFs)andotherrelevantclinicaldocumentstooptimizeclinicaltrialimplementation.

• Drivestheidentificationandinvolvementofqualifiedinvestigatorswithgreatestrecruitmentpotential,identifies clinicalrecruitmenthurdlesanddrivesclinicalrecruitmentactivitiestoovercomethesehurdles.

• Accountableforadherencetosafetystandardsandclinicaldataqualityinthecountrybyprovidinggeneral clinical/medicalsupportfortrialrelatedsafetyfindings.

• Inclosecollaborationwithothercountryfunctions(e.g.,clinicaltrialoperations,MedicalAffairsandPatient Engagement)activelycontributestosuccessfulallocation,fastclinicaltrialstart-up,timelyrecruitment,early identificationofpotentialdelays,anddevelopmentandimplementationofmitigationplans.

Job Responsibilities

Major Accountabilities

FromStrategytoFunctionalExcellence

ProvidesClinicalDevelopmentandindicationexpertisespecifictoCountry/Cluster,andtogetherwiththeclinicaltrial operationsteam,drivestheexecutionofclinicaltrialswithhighqualityandwithinplannedtime-lines:

• Validatesstudydesigns,isaccountablefor,andmakesthefinaldecisionontheclinical/medicaltrialand program feasibilityofimplementinga clinicaltrialprotocolbasedon medical/clinicalpracticeandanalysis ofthe competitive environment in the country.

• Activelycontributestoscientific/clinical/medicalaspectsofthestart-upphasetoensurefast clinicaltrialsite start-up.

• Providesclinical/medicalexpertisetoclinicaltrialoperationsteammembersand clinicaltrialsites for Institutional Review Boards (IRB)/ Ethics Committee (EC) interactions.

• Decidesonsite/Country-specificscientific/clinical/medicalcontentoftheInformedConsentForm(ICF)as needed and ensures appropriateness of patient suitable language.

• Providesscientific/clinical/medicalexpertiseduringinteractionswithCountry/ClusterexternalExperts(e.g., RegulatoryAuthorities,MedicalExperts,AdvisoryBoards,PatientAdvocacyGroups,etc.).

• Developsclinical/medicaltrialplanstakingthebroaderecosystemintoaccountforassignedpro-grams/trialsto ensure successful trial implementation, which includes:

  • Pro-activelyidentifyingearlyonclinicalchallengestorecruitmentorclinicaldataqualityanddrives development of clinical/medical mitigation plans.

  • Buildingdiseaseareaexpertise,especiallyfornew/rareindications

• Providesrobustindication,compound,andprotocoltraining:

  • Totheclinicaloperationsteaminthecountry,especiallytotheClinicalResearchAssociates,and other country line functions as needed.

  • Externallyasneeded intheCountry/Clusterat Investigator’sMeetingsorscientificvenuestosupport recruitment and trial awareness.

• Leveragesinnovationinclinicaltrialplanninganddecidesonclinical/medicalrecruitmentstrategyand implementationbased uponphysician interviews,analysis ofcompetitive trials,and patient engagement.

• Asthescientific/clinical/medicalexpert,supportsandpartnerswithinternalStakeholders(e.g.,ClinicalTrial Team,RegulatoryAffairs,MedicalInformation,MedicalAffairs,Marketing, PatientAccess, HECOR, clinicaltrial operations,etc.),andinternaldecisionboardsasneededregardingclinicaltrials.

• Gathers,informs,andactsoninsightsfromclinicaltrialInvestigators/sitestaff,MedicalExperts,patients,and payers,withinternalStakeholdersattheCountry/Clusterlevelwiththegoaltooptimizeclinicaltrial implementation.

• Supports planning, implementation, and follow-up ofscientific/clinical/medical components ofRegulatory Authority inspections and internal audits.

• Reviews and resolves Country trial-related scientific/clinical/medical issues/questions.If necessary, initiates the discussion with the Global Clinical Development team.

• Accountableforadherencetosafetystandards,clinicaldataqualityfortheCountry/Clusterandpro-vides general scientific/clinical/medical support for safety issues:

  • Providesclinical/medicalexpertise tosupportpharmacovigilance activities.

  • Maybeinvolvedinreviewingtheclinical/medicalaspectsofclinicaltrialSeriousAdverseEvents(SAEs) occurring in the Country and supports the patient safety team, and Global as needed to ensure high quality of clinical/medical information.

  • Follows-up withtheInvestigatorforadditionalclinical/medicalinformationorclarifications forAEsand SAEsandprovidesclinical/medicalexpertiseforsafetyamendments,InvestigatorNotifications(INs), Urgent Safety Measures (USM), etc. as needed.

• SupportstheGlobalClinicalDevelopmentteamasneededtoaddress/clarifyclinical/medicalProtocol Deviations through follow-up with clinical trial sites.

• MaysupportinnovativestudydesignsbyidentifyingandconductingqualityassessmentsofCountrydatasets (e.g.,Registries,ElectronicHealthRecords,Payerdata,RealWorldData,etc.).

• Drivesallclinical/medicalactivitiesinadherencetoGCP(GoodClinicalPractices),andinlinewithICH (International Conference on Harmonization) and Country regulations.

• Providesscientific/clinical/medicalinputtotheoverallProductstrategyattheCountrylevelwithanoptimized cross-functional Country team.

• MayrepresentClinicalDevelopmentatinternalandexternalmeetings.

• ProvidesasuperiorcustomerexperienceforInvestigators/sitestudyteams,significantlyimpactingtheexternal visibility and reputation of Novartis.

Education:
•Scientific degree M.D., Ph.D., or Pharm.D. (M.D. highly desirable, > 40 % of CRMA FTEs in a country if possible)
•Subspecialty training and/or RWE experience desirable, but not required.
Languages:
•Speaks and writes English.
•Speaks local language (if other than English).

Skills:
•Ability to manage a study from the scientific/medical/clinical perspec-tive, and a demonstrated capability to problem solve and mediate complex scientific/clinical/medical/operational issues.
•Ability to lead effectively by communicating well, motivating a cross-functional team, and handling and delegating responsibilities.
•Agility to move quickly across different therapeutic areas and indica-tions.
•Demonstrated problem-solving skills and comfort with complexity.
•Ability to prepare and deliver high quality presentations.
Experience:
•Ideally, 3 years of clinical development experience in the pharma-ceutical industry or clinical practice.
•Sound understanding of the overall clinical development process, and ICH/GCP principles.