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EMD Millipore
Director, Patient Centered Outcomes ResearchEMD Millipore • North Billerica, MA, United States
Director, Patient Centered Outcomes Research

Director, Patient Centered Outcomes Research

EMD Millipore • North Billerica, MA, United States
2 days ago
Salary
$172,000.00–$258,000.00 yearly
Job type
  • Full-time
Job description

Join EMD Electronics

Work Your Magic with us! Start your next chapter and join EMD Electronics.

Ready to explore, break barriers, and discover more? We know you've got big plans so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

Everything we do in EMD Electronics is to help us deliver on our purpose of being the company behind the companies, advancing digital living. We are dedicated to being the trusted supplier of high-tech materials, services and specialty chemicals for the electronics, automotive and cosmetics industries. We foster a global collaborative organization made up of individuals who have the passion to win, obsess about the customer, are relentlessly curious and act with urgency. Together, we push the boundaries of science to make more possible for our customers.

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.

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.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

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Director, Patient Centered Outcomes Research • North Billerica, MA, United States

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