digital healthoncologyregulatory strategypsychometricshealth economicsecoapatient reported outcomeseproclinical outcome assessmentspatient centered outcomes
Вакансия из Hirify Global, списка международных tech-компаний Для мэтча и отклика нужен Plus
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Зарплата и рынок
$212к-318к/год
$230к$270кмедиана$280к
По похожим ролям (18) ~ $270к/год
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Сильная вакансия
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Чётко очерченная руководящая роль в крупной биофармацевтической компании с заметным участием в онкологических запусках и глобальной регуляторной работе; высокие требования к опыту делают вакансию узкоспециализированной.
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Высокий порог входаПонятная зона ответственностиОнкологическое направление
Оценка от Hirify AI
Мэтч & Сопровод
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Описание вакансии
Текст:
Hirify AI/Оригинал
TL;DR
Director, Patient Centred Outcomes (Oncology): Architecting global clinical outcome assessment, patient experience data, and patient-reported outcome strategies for oncology launch, lifecycle, and early-phase programs with an accent on regulatory evidence, psychometric rigor, and patient-centered value demonstration. Focus on designing COA roadmaps, defending evidence for label claims, implementing eCOA/ePRO across 40+ countries, and integrating patient outcomes into payer and health technology assessment submissions.
Location: Remote/home-based; listed locations include Cambridge, Cambridgeshire, UK, London, UK, and California, US.
Salary: US-based candidates: $212,000–$318,000 base pay, plus potential bonus, equity, and benefits.
Company
hirify.global is a global biopharmaceutical company developing medicines for serious diseases, with a portfolio focused on sleep disorders, epilepsy, oncology, and neuroscience.
What you will do
Lead patient-centered evidence strategies for neuro-oncology and solid-tumor oncology launches, lifecycle expansions, and registrational programs.
Build early-phase COA roadmaps, disease conceptual models, and measurement strategies aligned with Target Product Profiles.
Develop regulatory strategies, briefing documents, clinical summaries, COA dossiers, and evidence supporting product-label claims with FDA, EMA, and other health authorities.
Oversee concept elicitation, cognitive debriefing, psychometric validation, translatability assessments, and COA integration into protocols, SAPs, and CSRs.
Direct global eCOA/ePRO implementation, including licensing, translation and linguistic validation across 40+ countries, electronic migration testing, and investigator training.
Collaborate with Medical Affairs, Commercial, Pricing and Market Access, Biostatistics, Clinical Operations, Patient Advocacy, and external scientific partners while mentoring junior PCO scientists and fellows.
Requirements
Master’s degree in Psychometrics, Health Outcomes Research, Health Economics, Epidemiology, Public Health, Behavioral Sciences, Psychology, or a related quantitative or clinical discipline; or a doctoral degree such as PhD, PharmD, or MD. A doctoral degree is strongly preferred.
8–10+ years of dedicated experience in Patient-Centered Outcomes, Clinical Outcome Assessments, Patient-Reported Outcomes, or HEOR within a global biopharmaceutical company or specialized consultancy.
Demonstrated success with 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 FDA, EMA, and PMDA, and applying FDA PFDD guidance to support label claims and review procedures.
Strong command of psychometric evaluation, mixed-methods research, qualitative interviewing, and questionnaire development and validation.
Deep understanding of patient-reported evidence in payer requirements, HTA methodologies including EU JCA, NICE, CADTH, and ICER, and commercial value narratives.
Hands-on experience directing global eCOA/ePRO trial operations, vendor management, and protocol integration.
Exceptional communication and presentation skills, including the ability to explain complex psychometric data and strategic rationales to executives, commercial stakeholders, and regulatory panels.
Culture & Benefits
Remote/home-based work arrangement is listed for the role.
Opportunity to work across global oncology, neuroscience, clinical development, regulatory, market access, and patient advocacy programs.
Benefits for eligible US-based employees include medical, dental and vision insurance, a 401(k) retirement savings plan, and flexible paid vacation.
Potential eligibility for discretionary annual cash bonus or incentive compensation and long-term equity grants.
hirify.global is an equal opportunity and affirmative action employer.
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