Director, Patient Centred Outcomes

Jazz Pharmaceuticals, Inc.; United States; Remote; USD 212,000 - 318,000; Full time

Benefits offered by this job

Medical, dental and vision insurance

401k retirement plan

Flexible paid vacation

Job summary

Jazz Pharmaceuticals, Inc. seeks a Director, Patient-Centered Outcomes to lead global COA, PRO, and patient experience strategies across oncology programs including DIPG and solid tumors.

You will collaborate with GVHEOR, Medical Affairs, and Regulatory teams to generate robust patient-focused evidence supporting label claims and lifecycle development. Ideal candidates have 8–10+ years in PCO/COA/PRO within a biopharma setting, with expertise in eCOA/ePRO deployment and a strong regulatory track

Qualifications

• Advanced degree in Psychometrics, Health Outcomes Research, or related quantitative field.
• Experience with PRO/COA strategies and regulatory submissions.
• Strong expertise in psychometric evaluation and questionnaire development.

Responsibilities

• Lead COA/PRO strategy across neuro-oncology and solid tumors.
• Partner with GVHEOR, Regulatory, and Payer teams to integrate PRO endpoints into value dossiers.
• Oversee eCOA/ePRO implementation and vendor management across global studies.
• Mentor teams in COA methods, trial design, and data interpretation.
• Engage with health authorities and prepare regulatory briefing materials.

Skills

Psychometrics

Mixed-methods

Qualitative interviewing

Questionnaire development

Education

Master's/Doctoral degree in relevant field

Doctoral degree strongly preferred

Job description

The Director, Patient-Centered Outcomes is a high-visibility, scientific, and strategic leadership role within the Global Evidence & Value Generation (EVG) organization. Reporting to the Head of Patient-Centered Outcomes, this leader will architect and execute global clinical outcome assessment (COA), patient experience data (PED), and patient-reported outcome (PRO) strategies. The primary mandate encompasses steering the patient-focused evidence strategies for Jazz's cornerstone oncology launch and lifecycle programs: 1. Neuro-Oncology: Accelerating peri-launch evidence, label negotiation, and patient/caregiver-centric value demonstration in rare neuro-oncology (diffuse midline gliomas / DIPG). 2. Oncology (Solid tumors): Driving registrational and lifecycle COA evidence generation across multiple solid tumor indications (including biliary tract cancer [BTC], gastroesophageal adenocarcinoma [GEA], breast cancer, and subsequent indication expansions). 3. Oncology & Cross-Therapeutic Pipeline: Future-proofing early-phase assets (Phase 1b through Phase 2) by defining fit-for-purpose measurement strategies aligned to Target Product Profiles (TPPs). This role requires a commercially astute and regulatory-experienced strategist capable of balancing scientific rigor with urgent commercial and market access timelines, demonstrating the humanistic value of Jazz therapies to Health Authorities, payers, clinicians, and patients globally.

Essential Functions/Responsibilities

• Neuro-Oncology Launch Leadership:
  • 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.
• Oncology Global Launch & Indication Expansion:
  • 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).
• Pipeline Architecture & Early Measurement Strategy:
  • 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.
• Regulatory Strategy, Label Negotiations, & Scientific Advice:
  • 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.
• Scientific Rigor, Clinical Trial Integration, & Digital Innovation:
  • 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.
• Cross-Functional Matrix Collaboration & External Engagement:
  • 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.
• Team Leadership & Talent Development:
  • Mentor and foster the professional growth of junior PCO scientists and fellows, championing a culture of scientific curiosity, strategic agility, and collaborative excellence.

Industry Experience

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.

Oncology Launch & Lifecycle Expertise

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.

Regulatory Track Record

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.

Methodological Expertise

Strong command of psychometric evaluation methods, mixed-methods research design, qualitative interviewing, and questionnaire development/validation.

Payer & HTA Fluency

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.

Technical & eCOA Execution

Hands-on experience directing global eCOA/ePRO trial operations, vendor management, and protocol integration.

Communication & Executive Presence

Exceptional communication and presentation skills; proven ability to articulate complex psychometric data and strategic rationales to executive leadership, commercial stakeholders, and regulatory panels.

Required/Preferred Education and Licenses

• Advanced Degree (Required): 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.

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.

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $212,000.00 - $318,000.00. Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation.