Vice President, Medical Affairs

Aufgaben

• Strategicleadershipandbusinessmanagement:Partnerwithexecutiveleadershiptodefineandexecutethelong-termMedicalAffairsstrategy,alignedwithorganizationalgrowthobjectives.Overseetheoperatingbudgetandprofit-and-lossperformanceforMedicalMonitoringandPharmacovigilance,optimizeresources,anddeliveragainstrevenueandmargintargets.
• MedicalMonitoringoversight:Directmedicalmonitoringactivitiesacrosstheclinicaltrialportfolio,ensuringprotocolcompliance,scientificrigor,andpatientsafety.Establishphysicianresourcingstrategies,overseerecruitmentandtraining,maintainstandardoperatingprocedures,andactastheescalationpointforcomplexmedicaldecisionsandsafetyconcerns.
• Pharmacovigilanceleadership:Overseepharmacovigilanceoperations,includingcaseprocessing,signaldetection,aggregatesafetyreporting,andregulatorysubmissions.Maintaincompliancewithinternationalandcountry-specificregulations,ensureauditandinspectionreadiness,andstrengthensafetyreportingprocesses,systems,andstaffcompetencies.
• Businessdevelopmentandclientengagement:Collaboratewithcommercialteamsonproposals,requestsforproposals,pricingstrategies,clientpresentations,andbiddefensemeetings.Buildandmaintainstrategicrelationshipswithsponsors,serveastheseniormedicalcontactforkeyaccounts,andcontributetobusinessgrowthandlong-termclientretention.
• Quality,compliance,andregulatoryoversight:EnsureMedicalAffairsactivitiesmeetapplicableregulatoryrequirements,qualitymanagementstandards,andsponsorexpectations.Overseestandardoperatingprocedures,qualityplans,correctiveandpreventiveactionplans,audits,andinspectionresponseswhilemonitoringevolvingglobalregulatoryrequirements.
• Technologyandprocessinnovation:EvaluateopportunitiestoimproveMedicalMonitoringandPharmacovigilancethroughtechnology,automation,andAI-assistedsolutions,includingenhancedcaseprocessing,signaldetection,andliteraturemonitoring.
• Peopleleadershipandorganizationaldevelopment:Lead,mentor,anddevelopamultidisciplinaryteamanditsfunctionalleaders.Establishworkforceplanning,performanceindicators,careerdevelopment,successionplanning,andleadershipdevelopmentinitiativeswhilefosteringaninclusive,accountable,andhigh-performingculture.
• Cross-functionalcollaboration:WorkcloselywithClinicalOperations,DataManagement,Biostatistics,RegulatoryAffairs,QualityAssurance,ScientificAffairs,andBusinessDevelopmenttosupportintegratedprogramdeliveryandconsistentqualitystandards.

Anforderungen

• Medicalqualifications:Medicaldegree(MD,DO,orequivalentinternationalqualification)isrequired.Boardcertificationindermatologyorrheumatologyisanadvantage,althoughastronggeneralistphysicianbackgroundisalsowelcome.AnMBAorotheradvancedbusinessqualificationisconsideredanasset.
• Professionalexperience:12–15yearsofprogressiveexperienceinthepharmaceutical,biopharmaceutical,orclinicalresearchindustry,including5–7yearsinaleadershippositionwithinacontractresearchorganization(CRO),pharmaceuticalcompany,orcomparableorganization.
• Functionalexpertise:DemonstratedexperienceleadingandscalingMedicalMonitoringandPharmacovigilancefunctions,withastrongunderstandingofglobalclinicaltrialregulations,patientsafetyrequirements,andqualitystandardsacrossmultipletherapeuticareas.
• Commercialandfinancialcapabilities:Provenexperienceengagingclientsinrevenue-generatingenvironments,contributingtobusinessdevelopment,andmanagingbudgetsorprofit-and-lossresponsibilities.Theabilitytodevelopcompetitiveservicepricingandalignresourceswithfinancialobjectivesisimportant.
• Regulatoryandqualityexperience:Experienceworkingwithhealthauthorities,supportingregulatoryinspections,managingaudits,anddefendingcompliancefindings.Familiaritywithglobalpharmacovigilanceobligationsandclinicalresearchregulatoryframeworksisessential.
• Executiveleadership:Ademonstratedabilitytoleadmultidisciplinaryteams,developfunctionalstrategies,manageorganizationalchange,andbuildacultureofscientificexcellence,accountability,andcontinuousimprovement.
• Communicationandrelationshipmanagement:Strongexecutivepresence,scientificcredibility,andtheabilitytocommunicatecomplexmedicalandsafetymattersclearlytosponsors,seniorleaders,regulators,andinternalteams.
• Preferredqualifications:ExperienceestablishingorscalingaMedicalAffairsfunction,familiaritywithpharmacovigilancesafetydatabasesandreportingautomationtools,andexposuretoAI-assistedmedicalmonitoring,pharmacovigilance,ormedicalwritingworkflows.Peer-reviewedpublications,scientificconferencepresentations,multilingualcapabilities,andinternationalregulatoryexperienceareadditionalassets.
• Workingstyleandavailability:Comfortableoperatinginafast-paced,growth-orientedglobalenvironment,collaboratingacrossfunctionsandgeographies,andtravelingfrequentlyasrequired.CandidatesmustbelegallyauthorizedtoworkinNorthAmerica.

Wir bieten

• Competitive compensation: Attractive executive-level compensation with performance-based incentives.
• Comprehensive benefits: Access to a full benefits package supporting employee well-being.
• Remote flexibility: Remote work arrangements available across North America.
• International exposure: Opportunities to collaborate with global teams, pharmaceutical sponsors, and clinical research professionals across multiple regions.
• Strategic influence: Direct participation in executive-level decision-making, business growth initiatives, and organizational strategy.
• Professional development: Opportunities to shape and expand Medical Affairs capabilities, explore emerging technologies, and contribute to scientific and operational innovation.
• Collaborative environment: A growth-oriented workplace that values collaboration, innovation, reliability, responsiveness, and high-quality delivery.
• Meaningful impact: The opportunity to influence patient safety, clinical trial integrity, and the quality of medical research across diverse therapeutic areas.

Sonstiges

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