Director, Patient Outcomes & Regulatory Strategy (Remote)

Lumanity; Boston (MA); Hybrid; USD 190,000 - 260,000; Full time

Benefits offered by this job

Bonus scheme

Health insurance options

401(k) plan with employer match

Paid holidays

Paid parental leave

Job summary

Lumanity is seeking a Director/Senior Director to provide strategic and scientific leadership for patient-centered outcomes (PCO) engagements. You will oversee COA projects, ensure scientific quality, and drive client relationships and revenue growth across the project portfolio.

Role requires advanced knowledge of COA literature, regulatory strategy, and cross-functional team leadership, with a focus on delivering fit-for-purpose evidence for regulatory submissions and decision-making.

Qualifications

• Master’s or Doctorate preferred; not required.
• 8+ years of progressive experience leading PCO and COA research.

Responsibilities

• Provide strategic and scientific leadership for PCO engagements.
• Lead COA projects including literature reviews, gap analyses, and dossier development.
• Own client relationships and drive business through sales and revenue generation.
• Ensure high scientific quality and compliance with SOPs.
• Guide client interactions and communicate recommendations clearly.
• Lead proposal scoping, budgeting, and win strategies.
• Train junior team members and oversee method execution.

Skills

COA leadership

Qualitative research

Regulatory strategy

Client management

Business development

Project leadership

Education

Master’s or Doctorate preferred

8+ years PCO/COA leadership

Job description

Lumanity is seeking a Director/Senior Director to provide strategic and scientific leadership for patient-centered outcomes (PCO) engagements. You will oversee COA projects, ensure scientific quality, and drive client relationships and revenue growth across the project portfolio.

Role requires advanced knowledge of COA literature, regulatory strategy, and cross-functional team leadership, with a focus on delivering fit-for-purpose evidence for regulatory submissions and decision-making.