Innovation Lead - Augmented RWD for Clinical Research – Post-doc position
Janssen has been a frontrunner in evaluating Real World Data (RWD) solutions for clinical research and has invested in the development and use of RWD/EHR platforms. These data and technology platforms have reached a level of maturity and provide valuable insights based on phenotypical data. However, augmented RWD is needed to gain accurate insights on the causes and progression of diseases. These insights will support the objectives of personalized medicine, allowing better adapted treatments and /or prevention programs depending on an individual’s specific needs. More and more clinical trials are collecting behavioral data from patients, and oftentimes also genomics data are being captured. It is expected that the technologies enabling this data capture in a controlled clinical trial setting, will also be applicable for long-term follow up and will enable the shift from a curative to a prevention model (including disease interception) or relapse prevention. Access to augmented RWD, such as the combination of continuous monitoring through wearables, phenotypical and genomics data will provide new tools for implementing personalized medicine and supporting future clinical trials.
We are looking for a PostDoc to lead innovation initiatives in the exciting new domain of augmented RWD. She/he will demonstrate the value of selective pilot solutions and to mature the successful pilot solutions in close cooperation with the R&D teams. The candidate should have prior experience in a clinical setting, combined with analysis of RWD or combined with a background in computer science /AI. The candidate will be joining a dynamic innovation team, focusing on the shaping and conducting of pilot projects, demonstrating value for patients, investigators and our company. The candidate should show initiative and the ability to work independently. She/he needs to have a sense of urgency, be well organized, and adhere to project timelines.
She/he will be assigned to a two-year R&D project (VLAIO PostDoc Innovatiemandaat) to demonstrate the value of augmented RWD for clinical development (disease area to be determined based on candidate background and clinical research questions but in one of the Janssen research domains). This will allow the candidate to gain experience in a multi-disciplinary domain, interacting with different therapy areas, several groups within global clinical development organization (GCDO), local Global Clinical Operations teams, Data Science groups in different functional areas. She/he will be a team member in a global team of leading-edge innovators in the area of digital / RWD solutions for clinical research.
Primary responsibilities (include, but are not limited to):
1. In close collaboration with the clinical innovation director and as a joint project with internal research partners, shape an augmented RWD initiative, which can consist of different pilots, e.g. combining different types of RWD such as phenotypical combined to genomics data and/or combined to behavioral data, depending on the research questions to be answered. Translate a research question into an appropriate solution, with augmented data defined in terms of access and analytic approaches. Shape these initiatives relying on medical / clinical knowledge.
2. Conduct the augmented RWD pilot projects together with a project team, being responsible for project management (responsible for planning timelines and resource activities and monitoring progress), as well as for the content development, leveraging relevant prior clinical, biomedical or data science experiences. Scope of activities include the collection of new data, as well as enriching existing data sets.
3. Leading the pilot evaluation and guiding potential transition from the clinical innovation group to the R&D teams, incl. recommendations on scaling the solutions, based on experience.
4. Define an appropriate data management strategy for each of the pilots and introduce a governance which is GDPR compliant and leverages data privacy by design.
5. Track state-of-the-art progress in augmented RWD and develop into an expert resource in augmented RWD. Propose innovative and actionable target ideas, aligned with strategy and capabilities.
6. Demonstrate the ability to manage the portfolio of the augmented RWD initiative, potentially consisting of multiple pilots.
7. Demonstrate the ability to analyze and present data in professional 'publication ready' format and proactively engage in abstract submission and identify publication opportunities.
Prior experiences, technical & personal skills:
• Experienced in working within the clinical development processes (from protocol design up to data analysis and reporting) and familiar with different types of clinical trials.
• Experience analyzing patient level data - phenotypical, genomics and behavior data (or proficient working with at least two of these data types).
• Strong analytic skills and advanced usage of a statistical package (R or SAS) and familiarity with predictive analytics research methods. Nice to have: advanced analytics packages, ML/AI experiences or experience with different NLP approaches.
• Familiarity with digital apps, eg wearables.
• Good understanding of the EU and US health care environment and data privacy regulations (nice to have: experience working on RWD in AsiaPac).
• Strong in root-cause analysis and solution-oriented.
• Diplomatic team player, strong interpersonal skills
• PhD degree in biomedical sciences, with a strong affinity for health informatics.
• At least 3 years of experience in an R&D environment in a hospital clinical setting, a pharmaceutical company or a CRO.
• IT proficiencies: Intermediary or advanced knowledge about SQL, excel; Statistical packaged R or SAS, predictive analytics methods. Knowledge about OMOP standards is an asset.
• Fluency in English (any other major language is an asset); excellent written and verbal communication at different levels of the organization, both at peer level and at senior management level.
What’s in it for you…?
“Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset. We take your career seriously. As part of a global team in an innovative environment your development is key and our day-to-day responsibility. Through e-university, on the job training, various projects and programs, we ensure your personal growth. Our benefits make sure we care for you and your family now and in the future! We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Janssen Pharmaceutica N.V. (7555)