Associate Director, Patient Centered Outcomes

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

📋 Description

• Develop and execute scientifically sound Clinical Outcome Assessment strategies for designated assets and development programs.

• Provide guidance on the selection, adaptation, development, validation, and implementation of COA instruments in clinical trials and observational research.

• Ensure that endpoint methodologies are defined early to assist in regulatory and reimbursement decisions.

• Utilize qualitative research, psychometric principles, and statistical methodologies to assess COA measurement properties.

• Participate in COA development and validation studies, including the collection and analysis of patient experience data.

• Deliver high-quality and timely outputs in Measurement Sciences.

• Support the implementation of digital measures and technology-enhanced endpoint strategies.

• Collaborate with digital health, data science, and technology partners regarding digital endpoints.

• Work collaboratively with clinical operations, biostatistics, regulatory affairs, medical affairs, and other stakeholders.

• Ensure that PRO/COA are accurately represented in protocols, statistical analysis plans, clinical study reports, and publications.

• Assist in the creation of briefing documents, health authority responses, and regulatory submissions.

• Support regulatory interactions and prepare scientific summaries concerning COA strategies.

• Contribute to publications, conference presentations, and participation in industry working groups.

• Establish relationships with external collaborators, academic partners, and vendors.

• Advocate for reusable endpoints, standardized processes, best practices, templates, and knowledge resources.

• Represent Measurement Sciences in asset team meetings, study teams, and governance forums.

• Foster scientific excellence, knowledge sharing, and capability development.

⛳️ Requirements

• Bachelor's degree in psychometrics, health outcomes research, epidemiology, biostatistics, public health, behavioral science, biomedical engineering, data science, or a related field.

• A minimum of 5 years of relevant experience in pharmaceuticals, biotechnology, digital health, CRO, or academic environments.

• Proven expertise in COAs, patient-centered outcomes, or related measurement science disciplines.

• Knowledge of FDA PFDD Guidelines and relevant international regulatory frameworks, including EMA reflection papers.

• Understanding of emerging frameworks for digital measures and digital endpoints.

• Experience in the development, validation, or implementation of COA instruments or digital measures in clinical trials.

• Familiarity with statistical techniques for assessing COA and/or digital endpoints, including psychometric analysis, mixed-effects models, and responder analyses.

• Documented contributions to scientific publications, conference presentations, or external working groups.

• An advanced degree in a related field is preferred.

• Experience working cross-functionally within a clinical development setting.

• Preferred experience in oncology, respiratory, hepatology, or infectious diseases and vaccines.

• Excellent written and verbal communication skills.

🏝️ Benefits

• Annual bonus.

• Eligibility to participate in a share-based long-term incentive program.

• Health care and other insurance benefits for employees and their families.

• Retirement benefits.

• Paid holidays.

• Vacation.

• Paid caregiver/parental and medical leave.

• Comprehensive benefits program for US employees.