Your contribution: Develop and execute global value evidence generation plans for SLR, ITC, CEA, BIA, RWE, and PRO to optimize clinical development decisions. Conduct global epidemiology literature reviews to inform multi-regional clinical trial site selection and recruitment. Provide guidance on FDA regulations for PROs and PFDD, ensuring alignment with labeling claims. Prepare regulatory‑grade documents (e.g., FDA/Global Regulatory briefing books) for PRO endpoint implementation, epidemiology, and pediatric investigation plans. Lead evidence synthesis strategies to support global pharmaceutical launches and reimbursement dossiers across HTA and Non‑HTA markets (e.g., PICOS simulation/scoping, feasibility assessment, development JCA dossiers). Develop early advice (EA) dossiers (country level and JSC); participate in stakeholder discussions and integrate emerging methods (including AI in SLR/ITCs/RWE). Collaborate with key opinion leaders via advisory boards and Delphi panels. Develop pre‑approval dossiers, launch models (CEA/BIA), tools, and HCEI training materials for US Account Management, Medical Science Liaisons, and field‑based HEOR professionals. Review other HEOR team members’ evidence generation plans/publications and provide constructive feedback. Mentor HEOR fellows and early‑career team members. A good match: MS required; PhD/PharmD/MD preferred in Public Health, Epidemiology, Health Economics, or related fields. At least 5 years relevant HEOR experience (or 10 years with MS) across SLR, ITC/NMA/MAIC/STC, CEA/BIA, RWE designs, and PRO analytics. Expertise in US/Ex‑US real‑world data sources (e.g., Komodo, Optum, Medicare RIF). eCOA implementation experience preferred; familiarity with FDA COA Type C meetings and negotiating PRO label claims a plus. Peer‑reviewed publication track record. Deep understanding of EU‑HTA requirements (JSC/EA/JCA) and global HTA guidelines. Excellent communication skills presenting HEOR research to payers/population health decision‑makers. Your Benefits: Medical, Dental and Vision Insurance; Life, AD&D, Critical Illness Insurance. Pre‑tax HSA & FSA, DCRA Spending Accounts; Employee Assistance & Concierge Program (EAP). Parental and Childbirth Leave & Family Planning Assistance; Sitterstream. Paid Time Off (Vacation, Sick, Bereavement, Holidays, Year‑End U.S. Shutdown). 401(K) plan with company match; tuition reimbursement; professional development. Commuting allowance/subsidized parking; discounted insurance (Home, Auto & Pet). #J-18808-Ljbffr
Global Heor Director
SCORPION THERAPEUTICS
berkeley heights, berkeley heights
Published 4 days ago
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