Director, Patient Centred Outcomes

This is a fully remote position, open to applicants in United States, +1 more country.

📋 Description

• Design and implement global strategies for clinical outcome assessments (COA), patient experience data (PED), and patient-reported outcomes (PRO).

• Drive patient-centered evidence strategies across neuro-oncology, solid tumor oncology, early-phase oncology, and cross-therapeutic pipeline programs.

• Develop and present evidence packages focused on patient needs, addressing aspects such as symptom relief, functional preservation, neurological stability, and tolerability.

• Create measurement strategies for pediatric, adolescent, and caregiver proxies related to diffuse midline glioma/DIPG.

• Conduct post-hoc analyses, qualitative exit interviews, and real-world studies on the burden of illness.

• Oversee the entire PRO and COA strategy for launch indications and lifecycle expansion initiatives.

• Craft comparative evidence strategies that showcase tolerability, quality of life, and delays in physical deterioration relative to standard care.

• Collaborate with Global Value & HEOR to integrate PRO endpoints into cost-effectiveness models, joint clinical assessments, ICER submissions, and global value dossiers.

• Analyze measurement landscapes, develop disease conceptual models, and create COA roadmaps from Phase 1b to Phase 2.

• Identify unmet patient needs to shape Target Product Profiles, clinical protocols, and differentiation strategies for assets.

• Lead regulatory efforts including the preparation of briefing documents, Type C meetings, FDA PFDD consultations, and EMA scientific advice procedures.

• Author and defend sections for regulatory submissions and COA evidence dossiers to obtain regulatory label claims.

• Manage concept elicitation, cognitive debriefing, psychometric validation, and assessments of translatability.

• Write COA sections for clinical trial protocols, Statistical Analysis Plans, and Clinical Study Reports.

• Direct the global implementation of eCOA/ePRO, encompassing licensing, translation, linguistic validation, migration testing, and investigator training.

• Investigate and apply Digital Health Technologies, biometric sensors, and decentralized assessment approaches.

• Work in collaboration with Medical Affairs, Commercial Brand Leads, Pricing & Market Access, Biostatistics, Clinical Operations, Clinical Development, and Regulatory Affairs.

• Partner with Global Patient Advocacy to ensure the inclusion of patient and caregiver perspectives in trials and research on disease burden.

• Supervise external vendors, academic research organizations, and clinical outcome consultants, while managing budget considerations.

• Represent Jazz at external consortia and lead initiatives for peer-reviewed publications and conference presentations.

• Mentor junior PCO scientists and fellows.

⛳️ Requirements

• A minimum of 8–10+ years of specialized experience in Patient-Centered Outcomes (PCO), Clinical Outcome Assessments (COAs), Patient-Reported Outcomes (PROs), or HEOR in a global biopharmaceutical setting or leading specialized consultancy.

• Proven track record in driving COA/PRO strategies for commercial launches, regulatory oncology filings, or significant lifecycle expansions in solid tumors and/or neuro-oncology.

• Experience in authoring regulatory briefing documents, engaging with health authorities (FDA, EMA, PMDA), and navigating FDA PFDD guidelines for label claims and review processes.

• Strong expertise in psychometric evaluation methods, mixed-methods research design, qualitative interviewing, and the development/validation of questionnaires.

• Comprehensive understanding of how patient-reported evidence aligns with global payer requirements, HTA methodologies, and narratives of commercial value.

• Practical experience in managing global eCOA/ePRO trial operations, vendor oversight, and protocol integration.

• Excellent communication and presentation abilities; capable of conveying intricate psychometric data and strategic insights to executive leadership, commercial stakeholders, and regulatory bodies.

• A 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 a related quantitative/clinical field.

• A Doctoral degree (PhD/PharmD) is strongly preferred.

🏝️ Benefits

• Discretionary annual cash bonuses or incentive compensation.

• Discretionary equity grants.

• Medical insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• 401k retirement savings plan.

• Flexible paid vacation options.