We’ve learned from experience that some of the best people don’t always match our requirements perfectly – if you’re interested and think you could fit, please don’t hesitate to apply.
Role can be based out of one of our three locations: Seattle, Bothell, WA or South San Francisco, CA
The Clinical Data Platform will be required to automate daily exchanges with Lyell’s clinical CRO, serve as a centralized data store (single source of truth), provide strict access control to data, enable biostatistics analytics, monitoring and analytics dashboards, and eventually enable predictive modeling and correlative studies. In addition, one of the key differentiators for this platform will be to link clinical data with CMC (manufacturing) data to provide insights into the manufacturing of Lyell’s cell therapies, and link this information to patient outcomes.
The platform will be built on AWS, and will leverage the foundational data lake, data pipelines, and analytics infrastructure that the Information Sciences software engineering team has built. You will be able to leverage Lyell’s cutting edge in-house team of data, analytics, frontend, backend, and DevOps engineers, and will be able to leverage UX designers as necessary.
We are looking for an experienced product manager that has a track record working with clinical trial data, and working with business, technology, and clinical teams to build software solutions that are data and analytics focused. We are looking for people who are passionate about data and how data can help improve patient outcomes!
Essential Functions:
Design and own the overarching Clinical Data Platform product strategy, roadmap, and execution
Work closely with Lyell’s Clinical team to understand their clinical trial strategy, clinical data management approach, biostatistics workflows, and biomarker sample/data strategy.
Develop a multi-year roadmap for the Clinical Data Platform, that delivers initial core value quickly, but builds a foundation for more advanced capabilities
Write user stories and specific product requirements, in order to communicate this to the Clinical stakeholders, and for the engineering team that will implement this
Be a product evangelist with the Lyell’s Clinical team
Lead the product development process to deliver a high quality software product
Provide second tier support for questions and enhancements
Establish KPIs to track and measure product success and future development opportunities
Preferred Experience:
Deep experience with clinical trials in biotech/pharma context
Solid understanding of overall drug development process
Deep knowledge of clinical applications including EDC, eTMF, CTMS, etc.
Experience working with Clinical CRO
5-10 years of product manager experience, including end-to-end discovery and delivery
Experience designing and building applications used in FDA regulated environments
Demonstrated leadership skills, including presentations of product vision to executives to get buy-in
Demonstrated experience with iterative product development
Experience developing data and analytics centric products
Experience working with UX designers (ability to create UX designs and wireframes is a bonus)
Preferred Education:
Degree (B.S., M.S. or PhD) in biological sciences, or other technical discipline
Preferred Additional Skills:
Experience with CDISC data set standards
Experience working with engineering teams developing applications on the cloud, particularly AWS
Experience with business intelligence (BI) tools for dashboards and reporting
Experience with CMC manufacturing processes and data in a life sciences context
Experience reading and understand data models
Excellent oral and written communication skills
Ability to work independently and collaboratively among cross-functional teams
Ability to work efficiently, prioritize workflow, meet deadlines and balance competing priorities.
Excellent analytical skills and scientific/technical expertise