Director, Patient Centred Outcomes

Brief 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

1. Strategic Leadership for Launch & Lifecycle Brands (Neuro-Onc/Onc)

* 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).

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

Required Knowledge, Skills, and Abilities

• 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.

#LI-DM1

#LI-Remote