Johnson & Johnson Innovative Medicine is looking to transform neuroscience clinical trials through cutting-edge AI, digital health technologies, and advanced statistical methodologies to enhance patient-centricity, streamline trial execution, and support regulatory and payer acceptance.
Requirements
- Experience in clinical development, digital health or outcome assessments, with demonstrated expertise in neuroscience preferred.
- Extensive experience in advanced analytical methodologies, including biostatistics, machine learning and statistical modeling of digital health data such as speech and sensor data and/or neuroimaging, and in multimodal data analysis approaches is required.
- Knowledge of state-of-the-art AI methods is an advantage.
- Strong track record in developing and validating digital health tools, clinical endpoints, or biomarkers, ideally with regulatory interactions.
- Experience integrating digital solutions into patient recruitment, screening, and clinical trial operations.
- Familiarity with data standards, privacy regulations, and regulatory qualification pathways for digital measures.
- Track record of scientific contributions (presentations and publications) in this field is required.
Responsibilities
- Partner with cross-functional teams to create strategic roadmaps that integrate digital health solutions throughout the patient journey, ensuring clinical relevance and patient-centered outcomes.
- Monitor emerging technologies and trends to bring forward next-generation solutions for neuroscience research and development.
- Partner with cross-functional teams (e.g., disease subject-matter-experts, data scientists, statisticians, precision measures leads and clinicians) on (a) study design, development and validation of algorithms and analysis pipelines for digital health data; (b) Development of multimodal approaches combining digital health data with imaging, blood-based biomarkers and real world data to enable precision neuroscience.
- Contribute to evidence packages to support regulatory qualification of digital endpoints and tools.
- Partner with regulatory and medical affairs to engage health authorities and payers on the acceptance of digital health approaches.
- Ensure validation and compliance with evolving global regulatory and data privacy standards.
- Collaborate with clinical operations to integrate digital health technologies into trial design.
Other
- Advanced degree (PhD, MD or equivalent) in neuroscience / quantitative sciences such as biomedical engineering, data science, biostatistics or a related field.
- 8+ years of experience in pharmaceutical, biotech, or healthcare analytics.
- Excellent cross-functional leadership, communication, and collaboration skills.
- This position may be located in Cambridge, MA, Titusville, NJ, or La Jolla, CA.
- May require up to approximately 10% yearly travel (international and domestic).
