Director, Patient Centred Outcomes

🔥 9 minutes ago

🌐 United States, United Kingdom – Remote

🇺🇸 United States – Remote 🇬🇧 United Kingdom – Remote

💵 $212k - $318k / year

⏰ Full Time

🔴 Lead

👔 Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Jazz Pharmaceuticals

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2003

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Jazz Pharmaceuticals is a biopharmaceutical company dedicated to developing innovative medicines that address serious unmet medical needs. With a strong commitment to research and development, Jazz focuses on creating life-changing therapies, emphasizing the importance of collaboration, diversity, and employee engagement in its operations. The company prides itself on transforming patients' lives through its meaningful product offerings and a culture that fosters enthusiasm and flexibility.

📋 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

🎯 Requirements

• 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

🏖️ Benefits

• 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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