Vital Therapies
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Provides strategic and operational statistical leadership for clinical development programs. Leads trial design, analysis plans, estimands, sample size, interim analyses, regulatory submissions, and interpretation of efficacy and safety results. Oversees CRO and vendor deliverables, budgets, timelines, quality, and compliance. Represents Biostatistics in cross-functional teams, governance forums, audits, inspections, and health-authority interactions. Mentors statisticians, programmers, and contractors while ensuring inspection-ready statistical work.
Lead global pharmacovigilance strategy and operations, including safety systems, signal detection, benefit-risk assessment, regulatory filings, medical review, compliance, CRO oversight, and safety governance. Partner with clinical development and regulatory teams, chair executive safety committees, and build high-performing pharmacovigilance teams through hiring, mentoring, and performance management.
Own Immunic’s global brand strategy and marketing organization for a potential relapsing MS therapy launch. Lead positioning, messaging, launch planning, market research, HCP and patient marketing, digital and omnichannel strategy, budgets, agencies, and international adaptation. Build the marketing function and team from the ground up while partnering with Market Access, Medical Affairs, Regulatory, Legal, Finance, and Patient Advocacy to ensure integrated commercial launch readiness.
Build and lead Immunic’s U.S. Market Access organization for the anticipated launch of vidofludimus calcium in relapsing multiple sclerosis. Own payer strategy, pricing, contracting, reimbursement, distribution, value propositions, evidence strategy, launch readiness, and specialty pharmacy relationships. Recruit and lead field market access teams while coordinating with Commercial, Medical Affairs, Regulatory, Finance, Legal, Supply Chain, and Sales to maximize patient access and commercial success.
