Director, Patient-Centered Outcomes

• Provides strategic and scientific leadership for patient-centered outcomes engagements
• Ensures research design, execution, and evidence packages are fit-for-purpose for client decision-making and regulatory use
• Leads clinical outcome assessment projects, including literature reviews, gap analyses, COA development and modification, in-trial interviews, regulatory strategy, and dossier development
• Defines scientific approaches by translating client objectives into tailored research designs and evidence-generation plans
• Develops endpoint and regulatory strategies for COA evidence packages supporting labeling claims
• Leads project teams by defining methodological approaches, confirming data requirements, and ensuring deliverables address research questions
• Reviews analyses, data interpretations, and client deliverables for scientific integrity, accuracy, scope alignment, and intended use
• Guides client interactions, frames options, communicates recommendations, and aligns stakeholders on research and evidence-generation decisions
• Ensures timely, high-quality delivery across the project portfolio, monitors execution, and course-corrects as needed to achieve annual revenue targets
• Expands existing accounts and develops new client opportunities
• Leads proposal development, including scoping and budgeting, and delivers against annual sales targets
• Provides direction and role-relevant 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
• Demonstrated expertise in developing COA strategies informed by literature reviews and gap analyses, delivering strategic insights aligned to the client's clinical, regulatory, and reimbursement objectives
• Demonstrated expertise in qualitative research and COA-focused methodologies, including standalone COA development/modification studies and the design, implementation, and execution of clinical trial interviews
• Demonstrated ability to develop endpoint and regulatory strategy for assigned projects by applying regulatory guidance and precedent to evidence plans, regulatory interaction support, and regulatory documentation
• Demonstrated expertise in methodologies required to deliver additional PCO service offerings, including Delphi panels and 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 experience navigating COA development with regulators and developing evidence to support medical product labeling claims
• Proven ability to lead multidisciplinary project teams delivering multiple concurrent engagements while maintaining scientific quality, timeline adherence, and clear decision-making
• Strong analytical and writing capability, including synthesizing complex evidence into clear, defensible client recommendations and fit-for-purpose deliverables
• Strong client-facing communication skills, including the ability to lead senior stakeholder discussions, present recommendations, and address complex scientific and strategic questions with clear, well-supported responses
• Demonstrated business development capability, including leading proposal scoping and budgeting, and contributing to sales and revenue generation

Core Competencies

Demonstrates expertise in leading patient-centered outcomes (PCO) and clinical outcome assessment (COA) research, developing endpoint and regulatory strategies, and delivering high-quality evidence packages to support medical product labeling claims. Proven ability to manage multidisciplinary project teams, ensuring scientific integrity and alignment with client objectives while driving business development and revenue generation.

Highest-signal resume keywords

• Patient-Centered Outcomes Research
• Clinical Outcome Assessment Methodologies
• Endpoint and Regulatory Strategy Development
• Qualitative Research Expertise
• Business Development and Proposal Leadership

Hard Skills

• COA Development
• Literature Review
• Gap Analysis
• Regulatory Documentation
• Clinical Trial Interview Design
• Survey Research
• Discrete Choice Experiments
• Goal Attainment Scaling
• Data Interpretation
• Evidence Generation

Soft Skills

• Client-Facing Communication
• Analytical Capability
• Team Leadership
• Stakeholder Alignment
• Decision-Making

Industry Keywords

• Drug Development Process
• Regulatory Guidance
• Medical Product Labeling Claims
• Proposal Development
• Revenue Generation