Contract Clinical Outcomes Researcher- MPS
Remote
Medical Organization – Clinical Development /
Contract /
Remote
The opportunity:
As a Contract Clinical Outcomes Researcher- MPS, you will support the development and execution of clinical outcomes strategies for MPS (Mucopolysaccharidoses) programs, particularly in the areas of neurodevelopment, functional performance, and patient-reported outcomes. Serving as a subject matter expert, you’ll advise on study design, protocol development, and endpoint selection to help ensure patient- and regulatory-relevant outcomes. You’ll also contribute to cross-functional collaborations, support the development of training materials and study documents, and provide input on COA data analysis and dissemination.
What you'll be doing:
- Support the development and implementation of clinical outcomes strategies for MPS programs, with a focus on neurodevelopment, functional performance, mobility, patient-reported outcomes (PROs), health-related quality of life, and healthcare resource utilization.
- Provide input into the training and qualification process for site raters and offer guidance to help ensure consistency in administration and scoring across sites.
- Contribute to the identification and recommendation of meaningful clinical endpoints—particularly in neurocognitive, behavioral, and functional domains—to support regulatory and patient-centered goals across early- and late-phase studies.
- Serve as a subject matter expert on neurodevelopmental assessments, advising on study design, endpoint selection, and protocol development.
- Collaborate with cross-functional teams including Clinical Science, Regulatory, Biostatistics, Patient Advocacy, Commercial, and Medical Affairs.
- Support the design of evidence-generation strategies aligned with the broader medical strategy and access objectives for the program.
- Liaise with Clinical Operations, CROs, and vendors to provide input on COA collection processes, helping ensure alignment with SOPs and ICH/GCP guidelines.
- Contribute to the development and review of COA execution strategies, including training materials, translations, source documentation, and study specifications.
- Review and provide feedback on project-related eCOA documentation throughout the project lifecycle.
- Collaborate with Biostatistics on COA data analysis plans, offering recommendations for data outputs including tables and figures.
- Work with Clinical Development and Medical Affairs to support the development and review of study reports, abstracts, and manuscripts related to COA content, and contribute to presentations for internal and external meetings or conferences.
What we're looking for:
- Post-baccalaureate degree in a health field (e.g., Ph.D., PharmD, DPT) required.
- Minimum 10 years relevant experience in industry positions as a contractor or employee.
- Experienced in biopharmaceutical drug development including, clinical investigational protocols, implementation of protocols, interpretation of data, and interactions with regulatory bodies.
- MPS or other lysosomal storage disorders experience preferred.
- Knowledge of gene therapy preferred.
- Demonstrates excellent presentation, verbal, and written communication skills; able to present information to diverse audiences in a clear and concise manner.
- Has strong planning and organizational skills with ability to set priorities effectively and efficiently. Able to manage multiple tasks, projects, and stakeholders.
- Has genuine empathy and compassion for patients and families and is committed to acting in the best interests of the patient community. Respects patient privacy.
- Able to build rapport quickly, and cultivate trusting, collaborative relationships both internally and externally.
- Is a self-starter and team player. Able to work collaboratively with others and influence towards common objectives. Promotes cross-functional collaboration and communication within organization. Inspires and motivates direct reports and team members.
- Shows adaptability, flexibility, and willingness to work in a changing environment.
