Director – Patient-Centered Outcomes

🕒 Yesterday

🌐 United States, United Kingdom – Remote

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🍂 Massachusetts – Remote

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⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 10%

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Logo of Lumanity

Lumanity

1001 - 5000 employees

Founded 2020

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Lumanity is focused on improving the candidate experience through modern digital solutions. The company's initiatives include streamlining the application process and utilizing anonymous data to enhance user interaction on their platform. They emphasize privacy and compliance in their operations, ensuring that candidate data is handled with care and transparency.

📋 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

🎯 Requirements

• 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

🏖️ Benefits

• 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

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