Moderna Therapeutics - Cambridge, MA
posted about 2 months ago
The Digital Principal Product Manager for Clinical Data at Moderna plays a pivotal role in shaping the data and analytics infrastructure for a rapidly growing mRNA drug development organization. This position is essential in leading efforts to identify and bridge gaps in the current and future states of clinical data standardization processes and management. The successful candidate will implement a unified and intelligent platform that supports the clinical data flow from the initial trial concept definition to the final data submission. Additionally, this role will focus on generating and utilizing insights from data to guide clinical development, ensuring that the organization remains at the forefront of innovation in the biotech industry. In this role, you will partner closely with clinical data management and biostatistics groups to drive and execute the data and analytics strategy. Collaboration with business stakeholders is crucial to understand their needs and identify gaps in the current data processes, automation, and insight generation. You will be responsible for driving data standardization and quality within clinical data management, influencing stakeholders with well-designed data policies and solutions. Furthermore, you will work alongside data engineering, informatics, and data science teams to develop modern analytics applications that leverage AI/ML and cloud-based technologies for proactive clinical data management. The position requires a strong background in clinical data management, with a minimum of 10 years of experience in the field, including clinical data submission. A solid understanding of industry data standards such as CDISC, SDTM, and ADaM is essential, along with proficiency in tools like Medidata Rave and programming languages such as SAS, R, or Python. The ideal candidate will have demonstrated success in leading product development initiatives and possess a strong understanding of Agile methodologies and product lifecycle management. Knowledge of technology in a GxP environment and data integrity requirements for clinical trials is also critical.