Director, Patient Centred Outcomes

🕒 il y a 8 jours

🌐 États-Unis, Royaume-Uni – Distant

🇺🇸 États-Unis – Télétravail 🇬🇧 Royaume-Uni – Télétravail

💵 $212 000 - $318 000 / an

⏰ Temps Plein

🔴 Expert

👔 Directeur

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

👻 Score fantôme 0%

Ce que ça veut dire : la probabilité que personne ne recrute vraiment pour cette offre.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Jazz Pharmaceuticals

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1001 - 5000 employés

Fondée en 2003

🏥 Santé

🏭 Fabrication

🧬 Biotechnologie

Healthcare • Manufacturing • Biotechnology

Jazz Pharmaceuticals est une entreprise biopharmaceutique dédiée au développement de médicaments innovants répondant à des besoins médicaux sérieux non satisfaits. Avec un fort engagement envers la recherche et le développement, Jazz se concentre sur la création de thérapies transformatrices, mettant en avant l'importance de la collaboration, de la diversité et de l'engagement des employés dans ses opérations. L'entreprise est fière de transformer la vie des patients grâce à ses offres de produits significatives et une culture qui favorise l'enthousiasme et la flexibilité.

Description

• Architect and execute global clinical outcome assessment (COA), patient experience data (PED), and patient-reported outcome (PRO) strategies • Steer patient-focused evidence strategies for neuro-oncology, solid tumor oncology, and early-phase oncology and cross-therapeutic pipeline programs • Formulate and deliver patient-focused evidence packages addressing symptom relief, functional preservation, neurological stability, and tolerability • Develop pediatric, adolescent, and caregiver proxy measurement strategies for diffuse midline glioma/DIPG • Execute post-hoc analyses, qualitative exit interviews, and real-world burden-of-illness studies • Lead end-to-end PRO and COA strategy across launch indications and lifecycle expansion programs • Design comparative patient-centered evidence strategies demonstrating tolerability, quality of life, and delay in physical deterioration versus standard of care • Partner with Global Value & HEOR to incorporate PRO endpoints into cost-effectiveness models, joint clinical assessments, ICER submissions, and global value dossiers • Map measurement landscapes, construct disease conceptual models, and establish COA roadmaps from Phase 1b through Phase 2 • Identify unmet patient-relevant needs to influence Target Product Profiles, clinical protocols, and asset differentiation strategies • Lead regulatory activities including briefing documents, Type C meetings, FDA PFDD consultations, and EMA scientific advice procedures • Author and defend regulatory submission sections and COA evidence dossiers to secure regulatory label claims • Oversee concept elicitation, cognitive debriefing, psychometric validation, and translatability assessments • Author COA sections within clinical trial protocols, Statistical Analysis Plans, and Clinical Study Reports • Lead global eCOA/ePRO implementation, including licensing, translation and linguistic validation, migration testing, and investigator training • Explore and implement Digital Health Technologies, wearable biometric sensors, and decentralized assessment methods • Collaborate with Medical Affairs, Commercial Brand Leads, Pricing & Market Access, Biostatistics, Clinical Operations, Clinical Development, and Regulatory Affairs • Partner with Global Patient Advocacy to incorporate patient and caregiver voices into trials and disease-burden research • Manage external vendors, academic research organizations, and clinical outcome consultants with budget oversight • Represent Jazz in external consortia and lead peer-reviewed publications and congress presentations • Mentor junior PCO scientists and fellows

🎯 Exigences

• Minimum of 8–10+ years of dedicated experience in Patient-Centered Outcomes (PCO), Clinical Outcome Assessments (COAs), Patient-Reported Outcomes (PROs), or HEOR within a global biopharmaceutical company or premier specialized consultancy • Demonstrated success driving COA/PRO strategies for commercial launches, registrational oncology filings, or major lifecycle expansions in solid tumors and/or neuro-oncology • Direct experience authoring regulatory briefing documents, engaging with health authorities (FDA, EMA, PMDA), and navigating FDA PFDD guidances to support label claims and review procedures • Strong command of psychometric evaluation methods, mixed-methods research design, qualitative interviewing, and questionnaire development/validation • Deep understanding of how patient-reported evidence integrates into global payer requirements, HTA methodologies, and commercial value narratives • Hands-on experience directing global eCOA/ePRO trial operations, vendor management, and protocol integration • Exceptional communication and presentation skills; proven ability to articulate complex psychometric data and strategic rationales to executive leadership, commercial stakeholders, and regulatory panels • Master’s degree (MS, MPH) or Doctoral degree (PhD, PharmD, MD) in Psychometrics, Health Outcomes Research, Health Economics, Epidemiology, Public Health, Behavioral Sciences, Psychology, or related quantitative/clinical discipline • Doctoral degree (PhD/PharmD) strongly preferred

🏖️ Avantages

• Discretionary annual cash bonus or incentive compensation • Discretionary equity grants • Medical insurance • Dental insurance • Vision insurance • 401k retirement savings plan • Flexible paid vacation

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