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About the Role

The Director, Patient-Centered Outcomes is a high-visibility, scientific, and strategic leadership role within the Global Evidence & Value Generation (EVG) organization. This leader will architect and execute global clinical outcome assessment (COA), patient experience data (PED), and patient-reported outcome (PRO) strategies, steering patient-focused evidence for Jazz's oncology launch and lifecycle programs.

Responsibilities

Formulate and deliver patient-focused evidence packages highlighting symptom relief, functional preservation, neurological stability, and tolerability in rare neuro-oncology populations.
Formulate specialized pediatric, adolescent, and caregiver proxy measurement strategies tailored to diffuse midline glioma/DIPG realities, addressing cognitive and motor decline.
Execute post-hoc analyses, qualitative exit interviews, and real-world burden-of-illness studies to bolster early launch narrative, scientific publications, and reimbursement dossiers.
Lead end-to-end PRO and COA strategy across primary launch indications (e.g., HER2-amplified BTC) and major lifecycle expansion programs (e.g., GEA, colorectal, metastatic breast cancer).
Design comparative patient-centered evidence strategies demonstrating superior tolerability, quality of life (HRQoL), and/or delay in physical deterioration versus standard-of-care systemic regimens.
Partner with Global Value & HEOR (GVHEOR) to incorporate PRO endpoints into cost-effectiveness models, joint clinical assessments (EU HTA / JCA), ICER submissions, and global value dossiers (GVDs).
Partner with early development teams to map the measurement landscape, construct disease conceptual models, and establish COA roadmaps from Phase 1b proof-of-mechanism into Phase 2 proof-of-concept.
Identify unmet patient-relevant needs early in development to influence Target Product Profiles (TPPs), clinical protocols, and long-term asset differentiation strategies.
Serve as the PCO lead across regulatory milestones, including briefing document authoring, Type C meetings, FDA PFDD consultations, and EMA scientific advice procedures.
Leverage deep operational knowledge of FDA PFDD Guidances (1–4), FDA 2009 PRO Guidance, and EMA reflection papers to design endpoints eligible for product labeling and differentiation.
Author and defend regulatory submission sections (e.g., Module 2.7.3/2.7.4 clinical summaries, Integrated Summary of Efficacy, and COA evidence dossiers) to secure regulatory label claims.
Oversee qualitative concept elicitation, cognitive debriefing, psychometric validation (Classical Test Theory and Item Response Theory/Rasch analysis), and translatability assessments across global studies.
Author COA sections within clinical trial protocols, Statistical Analysis Plans (SAPs), and Clinical Study Reports (CSRs) across all registrational and lifecycle studies.
Spearhead global eCOA/ePRO implementation, including instrument licensing, translation/linguistic validation across 40+ countries, electronic migration testing, and site investigator training.
Explore and implement innovative Digital Health Technologies (DHTs), wearable biometric sensors, and decentralized assessment methods to capture real-time physical function and performance outcomes.
Serve as the primary PCO strategic partner to Global Medical Affairs, Commercial Brand Leads, Pricing & Market Access, Biostatistics, Clinical Operations, Clinical Development, and Regulatory Affairs.
Partner with Global Patient Advocacy to weave authentic patient and caregiver voices into trial protocols, clinical endpoints, and disease-burden research.
Manage external scientific vendors, academic research organizations (AROs), and clinical outcome consultants, maintaining strict budget oversight and high-quality deliverables.
Represent Jazz in external consortia (e.g., ISPOR, ISOQOL, C-Path, Critical Path Institute eCOA Consortium) and lead peer-reviewed scientific publications and congress presentations.
Mentor and foster the professional growth of junior PCO scientists and fellows, championing a culture of scientific curiosity, strategic agility, and collaborative excellence.

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 (e.g., GI, breast, thoracic) 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 (e.g., EU JCA, NICE, CADTH, ICER), 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.

Skills

Patient-Centered Outcomes (PCO)
Clinical Outcome Assessments (COAs)
Patient-Reported Outcomes (PROs)
HEOR
Oncology Launch & Lifecycle Expertise
Regulatory Track Record
Methodological Expertise
Payer & HTA Fluency
Technical & eCOA Execution
Communication & Executive Presence

Location

Remote

Work Type

Remote

Experience Level

8-10+ years

Education Level

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.

Salary/Compensations

$212,000.00 - $318,000.00

Benefits

Discretionary annual cash bonus or incentive compensation
Discretionary equity grants
Medical, dental and vision insurance
401k retirement savings plan
Flexible paid vacation

About the Company

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families.
We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options.
We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.
Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience.
Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide.
Please visit www.jazzpharmaceuticals.com for more information.

Equal Opportunity

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.