Responsibilities / Position overviewThe Director/Senior Director provides strategic and scientific leadership for patient-centered outcomes (PCO) engagements, ensuring research design, execution, and evidence packages are fit-for-purpose for client decision-making and regulatory use. This role is accountable for leading clinical outcome assessment (COA) projects (for example, literature reviews, gap analyses, COA development and modification, in-trial interviews, regulatory strategy, and dossier development) while maintaining high scientific quality across deliverables. The Director also owns client relationships and drives business through sales and revenue generation.
Essential Duties/Responsibilities:- Strategic & Scientific Leadership: Defines the scientific approach for PCO engagements by translating client objectives into tailored research designs and evidence-generation plans aligned with regulatory guidance, evidentiary standards, and the client's strategic objectives.
- Endpoint & Regulatory Strategy: Develops endpoint and regulatory strategies for COA evidence packages supporting labeling claims, grounded in regulatory guidance, precedent, and emerging trends.
- Study Oversight & Technical Direction: Leads teams by defining the methodological approach, confirming data requirements, and ensuring deliverables address the research questions across project types.
- Quality & Scientific Integrity: Conducts senior-level review of analyses, data interpretations, and client deliverables to ensure they meet scientific integrity, accuracy, and alignment to scope and intended use, and ensures projects are conducted in compliance with the PCO Quality Management System and applicable SOPs.
- Client Leadership & Communication: Guides client interactions by framing options, signaling risks and potential benefits, communicating recommendations, and aligning stakeholders on decisions required to progress research and evidence generation.
- Project Accountability & Revenue Generation: Ensures on-time, high-quality delivery the across project portfolio by setting clear milestones and decision points, monitoring execution, and course-correcting as needed to achieve the annual revenue target.
- Business Development & Proposal Leadership: Drives growth by expanding existing accounts and developing new client opportunities; leads proposal development (scoping and budgeting) and delivers against the annual sales target.
- Team Direction & Technical Training: Provides direction and role-relevant technical training to more junior project team members by setting clear expectations for methods execution and deliverable quality.
Qualifications- 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 (e.g., study design), regulatory interaction support (e.g., correspondence, meeting materials), and regulatory documentation (e.g., briefing books, dossiers), escalating complex or novel issues as needed.
- Demonstrated expertise in methodologies required to deliver additional PCO service offerings, including Delphi panels and survey research (e.g., natural history studies), 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.
BenefitsWe offer our employees a comprehensive benefits package that focuses on what matters to you - health and well-being, personal finances, professional development, and a healthy work/life balance:
- 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 and more
-#LI-remote
