Director, Patient Centered Outcomes Research

Merck Group • $172K — $258K *
Billerica, MA 01821In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Master's degree or higher in a relevant field such as health outcomes measurement, psychology, or psychometrics.
  • 10+ years of experience in patient-centered research or outcomes research within the Pharmaceutical/Biotech industry.
  • Strong grasp of clinical drug development phases, particularly in Phase 3 and regulatory submission support.
  • In-depth knowledge of PFDD guidance and international regulatory standards regarding PFE and COA measurement.
  • Experience designing and executing Patient Experience Data studies using various methodologies.
  • Expertise in developing and validating Clinical Outcome Assessments (COAs).
  • Proven involvement in COA/PED elements in regulatory submissions.

Responsibilities

  • Lead and execute strategies for collecting and integrating patient experience data (PED) across assigned programs.
  • Develop COA measurement plans, conceptual models, and validate COA measures for clinical studies.
  • Integrate patient-experience considerations into program-level planning throughout drug development.
  • Design and deliver non-interventional studies and COA validation projects.
  • Act as a subject matter expert on methodologies related to PED and COA measurement for cross-functional teams.
  • Ensure compliance and quality of all deliverables with regulatory guidelines and best practices.
  • Build partnerships with academic institutions, advocacy groups, and research organizations.

Benefits

  • Health insurance coverage.
  • Paid time off (PTO) for work-life balance.
  • Retirement contributions to support future savings.
  • Potential for performance-based bonuses and other perks.
Full Job Description
Your Role:

The Director, Patient-Focused Evidence (PFE) is an experienced scientific expert in patient-focused evidence and clinical outcome assessment (COA) measurement, contributing to and supporting development programs at a global level. This role leads the development and execution of PFE strategies for assigned programs, including working cross-functionally to plan and implement patient experience data (PED) generation and providing expertise on COA measurement for studies - ultimately ensuring that the patient voice is robustly represented in regulatory submissions and informs decisions that improve patient access and outcomes. The Director serves as a key scientific reference for assigned programs, applies advanced methodological expertise, and contributes to raising quality and standards across the team - without formal line management responsibilities.

Location: This is a hybrid (3x/week) in office position located in Billerica, MA. #LI-Hybrid

Key Responsibilities:
  • Lead development and execution of evidence strategies for collecting and integrating patient experience data (PED) for assigned programs, in close collaboration with key internal and external stakeholders, aligned with clinical development timelines and health authority expectations.
  • Lead the development of COA measurement plans for assigned programs, including development of conceptual models, selecting, developing, and validating COA measures and endpoints for clinical and non-interventional studies (NIS). This includes input into PED/COA aspects of clinical trial protocols and statistical analysis plans (SAP), results interpretation, and dissemination.
  • Ensure integration of patient-experience/benefit considerations and related evidence gaps in program-level planning, as a key component of integrated evidence plans (IEP), throughout the drug research, development, and commercialization stages.
  • Lead design, execution, and delivery of non-interventional studies for generating regulatory-grade Patient Experience Data (PED), and COA development and validation projects.
  • Serve as subject matter expert on qualitative, quantitative, and mixed-methods methodologies of PED and COA measurement for assigned programs; represent PRWE in relevant cross-functional governance bodies and scientific forums.
  • Ensure high impact of deliverables by understanding business priorities and addressing customer needs within a matrix organizational structure.
  • Ensure quality, reproducibility, and compliance of all PFE deliverables with applicable regulatory guidelines and best practice [e.g., ISPOR good practice guidance, FDA PFDD guidance, China FDA guidance, and EMA PED reflection paper] and internal quality standards.
  • Build and maintain partnerships with academic institutions, patient advocacy groups, clinical investigators, data vendors, and CROs, aligned with program and organizational priorities.
  • Represent Company at scientific conferences and therapeutic area-specific meetings; contribute to peer-reviewed publications, conference presentations, and scientific communications; engage in relevant industry working groups on PFE methodology and standards.
  • Act as a scientific mentor and role model to less senior PFE scientists; share expertise to raise scientific standards throughout the team.
  • Lead PED/COA-related aspects in regulatory engagements and submissions for assigned programs, e.g., preparation of COA measure and PED dossiers.
  • Contribute to patient engagement activities related to program strategy or clinical studies, including patient advisory boards, panels, and councils.
  • Manage project-related contracting, budget, and resources; oversee vendor and partner management for assigned programs.


Who You Are

Minimum Qualifications:
  • Master's degree (or higher) in socio-behavioral sciences, health outcomes measurement, psychology, behavioral sciences, ethnography, psychometrics, or related field.
  • 10+ years in patient-centered research, patient-focused drug development, or outcomes research in the Pharmaceutical/Biotech industry.
  • Strong understanding of clinical drug development and lifecycle management; demonstrable experience supporting key phases of a clinical program (e.g., initiation of Phase 3, regulatory filing).
  • Deep understanding of PFDD guidance and regulatory expectations on PFE and COA measurement, internationally (including FDA, EMA, Chinese FDA).
  • Demonstrable experience and knowledge of designing and implementing PED studies - applying qualitative, quantitative, and mixed-methods.
  • Demonstrable expertise in developing and validating COA measures.
  • Demonstrable experience contributing to COA/PED-related aspects in regulatory engagements and submissions.


Preferred Qualifications:
  • Doctoral degree (PhD, MD) in socio-behavioral sciences or related field.
  • Proven ability to influence stakeholders and operate effectively in a matrixed, cross-functional environment without direct authority.
  • Strong conceptual, methodological, and analytical skills.
  • Curious, innovative, and solution-focused mentality.
  • Excellent scientific communication skills with ability to translate complex technical concepts into clear, actionable recommendations for diverse audiences.
  • Ability to work effectively in ambiguity and navigate complex stakeholder environments.
  • Collaborative mindset with ability to build trust across functions and with external partners.
  • Demonstrable ability to integrate AI tools in daily scientific work.
  • Experience across multiple therapeutic areas.
  • Familiarity with digital health technologies and wearable devices.
  • Experience applying novel methodologies in evidence planning and generation.
  • Emerging track record of scientific contributions in PFE (publications, conference presentations).
  • Experience with FDA/EMA COA qualification processes.


Pay Range for this position: $172,000 - 258,000
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.

About Merck Group

Merck Group Careers

There has never been a more opportune time to join Merck Group, a leading science and technology company in healthcare, life science, and performance materials. Merck Group offers a plethora of job opportunities that cater to a variety of skills and professional aspirations, making it an ideal environment for both seasoned experts and those at the start of their career journey.

Work You’ll Do

At Merck Group, every team member contributes to breakthrough innovations in healthcare, life sciences, and electronics. The company's commitment to diversity and innovation fuels its leadership in various sectors, driving growth and transformation globally. Merck Group’s career paths are diverse, offering positions that challenge individuals to use their skills in new ways every day, supported by robust training programs and development opportunities.

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Merck Group is not just about jobs; it's about building a career. With a vast array of positions, from research and development to marketing and sales, the company is keen on hiring and nurturing talent to lead industry transformation. Merck Group’s dedication to professional growth is evident in its comprehensive benefits package and performance management processes that aim to maximize individual potential.

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Starting with an internship at Merck Group can be a pivotal step in securing a prosperous career. Interns gain invaluable industry experience, working alongside seasoned professionals and engaging in projects that offer real-world applications of their studies. Internships often lead to full-time employment opportunities, providing a seamless transition from education to professional employment.

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Merck Group is proud of its inclusive culture that embraces diversity and fosters an environment where all employees can thrive. The company’s leadership is committed to creating a workplace where diverse ideas lead to innovative outcomes. Merck Group also offers diversity training to ensure all team members are equipped to contribute to the company’s inclusive goals.

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Employees at Merck Group are encouraged to engage in networking and professional development activities that enhance their career trajectories. The company hosts various networking events, workshops, and seminars that are designed to hone skills and foster connections within the industry. Leadership development programs are also a cornerstone, preparing employees for future roles of increased responsibility.

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Pharmaceuticals & Biotech
* Ladders Estimates

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