About this role
The Director, GPO Clinical Support, Multispecialty provides clinical and regulatory expertise to support GPO manufacturer business development. The role monitors FDA and label changes, conducts clinical reviews across multiple therapeutic areas, and translates evidence into contracting strategy and member value.
Key Responsibilities
- Provide clinical and regulatory support for multispecialty GPO pharmaceutical portfolios, including monitoring FDA approvals, label changes, PDUFA timelines, and emerging clinical data
- Conduct clinical reviews of branded, generic, and biosimilar products to support contracting, formulary, and valuebased decisionmaking
- Summarize and interpret clinical trial data and regulatory information for internal crossfunctional partners
- Respond to clinical inquiries related to drug utilization, indications, and regulatory status across multispecialty therapeutic areas
- Collaborate with Analytics teams and coordinate with Legal and Compliance partners on clinical review of contract language and related materials
Technical Overview
This position is clinical/regulatory analytics focused: interpret clinical trial data and regulatory updates, assess branded/generic/biosimilar evidence, and build therapeutic area reference tools. It requires coordination with analytics, contracting, provider engagement, and Legal/Compliance teams for contract-cycle support.
Ideal Candidate
The ideal candidate is a clinical/regulatory director-level professional with experience supporting GPO pharmaceutical relationships across multiple therapeutic areas. They can independently monitor FDA approvals, label changes, and PDUFA timelines, perform clinical reviews of branded, generic, and biosimilar products, and translate evidence into formulary and contracting insights while partnering closely with Legal and Compliance.
Must-Have Skills
Provide clinical and regulatory support for multispecialty GPO pharmaceutical portfoliosMonitor FDA approvalslabel changesPDUFA timelinesand emerging clinical dataConduct clinical reviews of brandedgenericand biosimilar products to support contractingformularyand valuebased decisionmakingTranslate clinical evidencemarket dynamicsand regulatory considerations into actionable insightsCoordinate with Legal and Compliance partners on clinical review of contract language and related materials
Required Skills
clinical and regulatory supportFDA approvalslabel changesPDUFA timelinesclinical reviews (brandedgenericbiosimilar)clinical trial data interpretationregulatory informationdrug utilizationindicationsregulatory statusformulary positioningcomparative clinical assessmentstherapeutic area reference toolsutilization trends analysislegal and compliance contract language reviewmanufacturer engagement
Hard Skills
clinical and regulatory supportFDA approvals monitoringlabel changes monitoringPDUFA timelines trackingclinical reviews of branded productsclinical reviews of generic productsclinical reviews of biosimilar productsformulary decision supportvalue-based decisionmakingclinical trial data interpretationregulatory information interpretationdrug utilization inquiry supportindications knowledgeregulatory status assessmentmanufacturer engagement supportpipeline evaluation supportprelaunch asset evaluation supportformulary positioningcomparative clinical assessmentsutilization trends contextualizationtherapeutic class dynamics analysismarket change trackingclinical review of contract languagetherapeutic area reference tools developmentdrug comparisons by indicationdrug comparisons by formulationdrug comparisons by route of administrationinternal briefing documents creationsummaries and reference materials creationevidence-based clinical insight
Soft Skills
cross-functional collaborationstakeholder managementcommunicationanalysispartnership with teamsability to synthesize complex clinical/regulatory informationproblem-solving
Keywords for Your Resume
DirectorGPO Clinical SupportMultispecialtyGPOclinical and regulatory supportFDA approvalslabel changesPDUFA timelinesclinical trial dataregulatory informationbranded productsgeneric productsbiosimilar productsformularyvaluebased decisionmakingdrug utilizationindicationsregulatory statusmanufacturer strategymanufacturer engagementpipeline evaluationprelaunch assetscomparative clinical assessmentstherapeutic area reference toolsdrug comparisons by indicationroute of administrationLegal and Complianceinternal briefing documentsutilization trendstherapeutic class dynamicsmarket changes
Deal Breakers
Must have experience conducting clinical reviews for branded, generic, and biosimilar products, Must be able to monitor and interpret FDA approvals, label changes, and PDUFA timelines, Must be able to coordinate clinical review work with Legal and Compliance partners
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