Director, Patient Centered Outcomes Assessment

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Oversee intricate patient-centered outcomes research initiatives from the design phase through to final delivery.

• Act as the project lead for multidisciplinary teams, ensuring timely project delivery, adherence to scope, and compliance with the highest scientific standards.

• Provide strategic guidance on study design, methodologies, regulatory interactions, and evidence generation plans.

• Manage project risks, client expectations, resource distribution, and team performance.

• Actively participate in the design, execution, analysis, interpretation, and reporting of qualitative and mixed-methods research studies.

• Design and conduct qualitative research involving patients, caregivers, patient advocates, and clinical key opinion leaders, encompassing both stand-alone and clinical trial-based studies.

• Spearhead the development, adaptation, and assessment of clinical outcome assessments (COAs), including patient-reported outcomes (PROs), observer-reported outcomes (ObsROs), clinician-reported outcomes (ClinROs), and similar measures.

• Review and critically evaluate published literature, COA development programs, and psychometric evidence.

• Formulate patient-centered evidence strategies to address regulatory, access & reimbursement, and healthcare decision-making requirements.

• Directly contribute to study reports, client presentations, evidence dossiers, briefing books, and negotiations with key decision-makers to advocate for patient-centered value messaging in pharmaceuticals.

• Establish and nurture strong relationships with current and potential clients.

• Lead scientific discussions with pharmaceutical and biotechnology sponsors regarding strategies for patient-focused drug development.

• Assist in business development activities through proposal creation, client meetings, capability presentations, and identifying growth opportunities.

• Lead and contribute to scientific publications, conference abstracts, posters, presentations, and manuscripts.

⛳️ Requirements

• A postgraduate master's degree with a minimum of 8 years of experience in patient-centered research, or a PhD with at least 5 years of experience in the same field.

• Proven experience in leading complex patient-centered research projects and multidisciplinary teams in consulting, pharmaceutical, regulatory, CRO, or academic research contexts supporting patient-focused drug development.

• Demonstrated success in managing client relationships, mentoring research personnel, and guiding project teams.

• Extensive experience in developing and executing patient-centered evidence-generation strategies for pharmaceutical clients.

• Proven track record of interactions with regulatory agencies, including the FDA, EMA, or other global health authorities, along with supporting evidence requirements for access stakeholders (payers, HTA, and prescribers).

• Experience in leading proposal development and contributing to business growth strategies.

• A strong publication record and experience in presenting research at scientific conferences.

🏝️ Benefits

• Competitive base salary.

• Generous paid time off policy.

• Merit-based annual increases.

• Bonus opportunities.

• Robust recognition program.

• Competitive range of insurance plans (including health, dental, life, and short-term and long-term disability).

• Access to a retirement savings program such as a 401(k) plan.

• Paid parental leave for all parents.

• Financial assistance with adoption expenses or infertility treatments.

• Financial reimbursement for educational and developmental opportunities.

• Employee assistance program.

• Numerous additional offerings to promote a healthy work-life balance.