Moderna
Sr. Product Manager, Clinical Biomarker LIMS
Moderna, Cambridge, Massachusetts, us, 02140
The Role:
We are actively seeking a Senior Product Manager to lead our Clinical Biomarker digital products space, focusing on Lab Information Management Systems (LabVantage and Watson). This role offers a unique opportunity to merge laboratory expertise with digital product management skills, overseeing the strategy, development, and support of critical software products used in our innovative clinical biomarker environment. The ideal candidate will have a robust background in clinical biomarker labs, combined with proven digital product management experience.
Here’s What You’ll Do: Collaborate with business stakeholders to understand their needs and identify gaps between current and future states related to data processes, automation, and insight generation. Document business and functional requirements for system features and process changes. Lead end-user design workshops to refine personas, epics, and user stories. Author or co-author essential documents, including epics, user stories, functional and design documents, Configuration Specifications, Test Plans, Work Instructions, and SOPs. Assist in creating test plans and detailed test cases to ensure functional requirements are met. Lead user acceptance testing (UAT) as needed to confirm that software implementations meet business needs.
Here’s What You’ll Need (Minimum Qualifications): Bachelor's degree in Science, Biotechnology, Engineering, Computer Science, or equivalent. 7+ years of experience in product management, specifically in digital products within the biotechnology or pharmaceutical industries. First-hand knowledge of technology in a GxP environment and an understanding of data integrity requirements for clinical trials. Experience working with a leading LIMS solution. Ability to identify and adapt business processes in response to changing needs. Approach problem-solving and system design from the end-user experience perspective, using user-centered design principles and encouraging intuitive and streamlined UIs/workflows whenever possible.
Here’s What You’ll Bring to the Table (Preferred Qualifications): Proven experience with clinical trial data flow, processes, and standardization. Experience with LabVantage or Watson LIMS solutions. Experience with Computerized System Validation (CSV) and global regulatory requirements for data privacy and protection (GDPR). Ability to identify opportunities to use data as an asset to drive operational efficiency and generate novel insights to accelerate processes. First-hand experience in Product Management operating principles and tools (JIRA, Persona Definitions, Road mapping, and the hierarchy of Initiative: Epic: Story). Proven ability to navigate the complexities of developing software products that comply with clinical biomarker lab needs and requirements. Ability to work independently yet engage proactively with team members, colleagues, and stakeholders to get alignment and drive solutions forward. Exceptional leadership, communication, and interpersonal skills to manage and motivate cross-functional teams. An innovative, problem-solving mindset, with a track record of translating clinical laboratory challenges into successful digital solutions.
About Moderna: Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer. Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. #J-18808-Ljbffr
Here’s What You’ll Do: Collaborate with business stakeholders to understand their needs and identify gaps between current and future states related to data processes, automation, and insight generation. Document business and functional requirements for system features and process changes. Lead end-user design workshops to refine personas, epics, and user stories. Author or co-author essential documents, including epics, user stories, functional and design documents, Configuration Specifications, Test Plans, Work Instructions, and SOPs. Assist in creating test plans and detailed test cases to ensure functional requirements are met. Lead user acceptance testing (UAT) as needed to confirm that software implementations meet business needs.
Here’s What You’ll Need (Minimum Qualifications): Bachelor's degree in Science, Biotechnology, Engineering, Computer Science, or equivalent. 7+ years of experience in product management, specifically in digital products within the biotechnology or pharmaceutical industries. First-hand knowledge of technology in a GxP environment and an understanding of data integrity requirements for clinical trials. Experience working with a leading LIMS solution. Ability to identify and adapt business processes in response to changing needs. Approach problem-solving and system design from the end-user experience perspective, using user-centered design principles and encouraging intuitive and streamlined UIs/workflows whenever possible.
Here’s What You’ll Bring to the Table (Preferred Qualifications): Proven experience with clinical trial data flow, processes, and standardization. Experience with LabVantage or Watson LIMS solutions. Experience with Computerized System Validation (CSV) and global regulatory requirements for data privacy and protection (GDPR). Ability to identify opportunities to use data as an asset to drive operational efficiency and generate novel insights to accelerate processes. First-hand experience in Product Management operating principles and tools (JIRA, Persona Definitions, Road mapping, and the hierarchy of Initiative: Epic: Story). Proven ability to navigate the complexities of developing software products that comply with clinical biomarker lab needs and requirements. Ability to work independently yet engage proactively with team members, colleagues, and stakeholders to get alignment and drive solutions forward. Exceptional leadership, communication, and interpersonal skills to manage and motivate cross-functional teams. An innovative, problem-solving mindset, with a track record of translating clinical laboratory challenges into successful digital solutions.
About Moderna: Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer. Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. #J-18808-Ljbffr