Director – Patient-Centered Outcomes

🕒 il y a 11 jours

🌐 États-Unis, Royaume-Uni – Distant

🇺🇸 États-Unis – Télétravail 🇬🇧 Royaume-Uni – Télétravail

🍂 Massachusetts – Distant

🍂 Massachusetts – Remote

⏰ Temps Plein

🟠 Senior

👔 Directeur

👻 Score fantôme 10%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Lumanity

Site WebLinkedInTous les Emplois

1001 - 5000 employés

Fondée en 2020

🏥 Santé

💼 Conseil

📦 Logistique

Healthcare • Consulting • Logistics

Lumanity se concentre sur l'amélioration de l'expérience des candidats grâce à des solutions numériques modernes. Les initiatives de l'entreprise incluent la rationalisation du processus de candidature et l'utilisation de données anonymes pour améliorer l'interaction des utilisateurs sur leur plateforme. Ils mettent l'accent sur la confidentialité et la conformité dans leurs opérations, garantissant que les données des candidats sont traitées avec soin et transparence.

Description

• Provide strategic and scientific leadership for patient-centered outcomes engagements • Translate client objectives into tailored research designs and evidence-generation plans • Develop endpoint and regulatory strategies for clinical outcome assessment evidence packages supporting labeling claims • Lead literature reviews, gap analyses, COA development and modification, in-trial interviews, regulatory strategy, and dossier development • Define methodological approaches, confirm data requirements, and ensure deliverables address research questions • Review analyses, data interpretations, and client deliverables for scientific integrity, accuracy, scope, and intended use • Ensure compliance with the PCO Quality Management System and applicable SOPs • Guide client interactions, frame options, communicate recommendations, and align stakeholders • Manage project milestones, decision points, execution, and course correction across the project portfolio • Drive account expansion, new client opportunities, proposal development, scoping, budgeting, sales, and revenue generation • Provide direction and technical training to junior project team members

🎯 Exigences

• Master’s or doctorate degree in a health-related field preferred, not required • Minimum 8 years of progressive experience leading PCO and COA research, with accountability for scientific and strategic direction of endpoint evidence generation to support medical product labeling claims • Expertise in developing COA strategies informed by literature reviews and gap analyses • Expertise in qualitative research and COA-focused methodologies, including standalone COA development/modification studies and clinical trial interviews • Ability to develop endpoint and regulatory strategy using regulatory guidance and precedent for evidence plans, regulatory interaction support, and regulatory documentation • Expertise in additional PCO methodologies, including Delphi panels, survey research, patient preference studies, discrete choice experiments, and goal attainment scaling; desired but not required • In-depth understanding of the drug development process, including navigating COA development with regulators and developing evidence to support medical product labeling claims • Ability to lead multidisciplinary project teams across multiple concurrent engagements while maintaining scientific quality, timelines, and clear decision-making • Strong analytical and writing capability • Strong client-facing communication skills and ability to lead senior stakeholder discussions • Demonstrated business development capability, including proposal scoping and budgeting and contributing to sales and revenue generation

🏖️ Avantages

• Competitive salary plus bonus scheme • Medical, dental, and vision insurance options • 401(k) plan with employer match • Flexible paid time off program + 10 paid holidays • Flexible spending accounts for health and dependent care • Health savings account option with employer contribution • Employee Assistance Program • Paid short-term and long-term disability coverage • Company-paid life insurance coverage at 1.5x annual salary • Paid parental leave