Product Manager

Instem•Boston, MA

11d•Hybrid

About The Position

d-wise, an Instem company, makes validated, compliant statistical computing simple — so clinical teams can focus on the science, not the infrastructure. We build and manage the SCE platforms that sit behind regulatory submissions, and our work directly enables the approvals that bring new medicines to patients. We are looking for an experienced Product Manager to help shape and deliver the next generation of our clinical trial technology platform. You’ll be part of a friendly, solutions-focused environment within a global business of over 400 people. Here, you’ll experience a high-performance culture balanced with genuine flexibility - we trust you to take ownership, deliver meaningful results, and work in a way that suits you. You’ll be encouraged to grow, share your ideas, and make a real impact. We’re passionate about creating a place where you can develop your skills, contribute confidently, and succeed in your career. This is a high-impact role within a fast-growing organization at the intersection of open-source technology, cloud infrastructure, and FDA-regulated software. You will serve as the connective tissue between our clients, internal stakeholders, and engineering teams — owning the product backlog, driving sprint delivery, and translating complex life sciences requirements into well-defined, actionable user stories.

Requirements

Product ownership — Proven experience owning and prioritising a product backlog, defining product vision, and delivering roadmaps aligned to customer and business needs.
Agile leadership — Hands‑on experience leading Agile ceremonies (sprint planning, stand‑ups, reviews, retrospectives) in partnership with engineering and QA teams.
Stakeholder management — Strong ability to act as the primary liaison between clients, internal teams, and cross‑functional stakeholders, ensuring alignment throughout the development lifecycle.
Clinical or regulated domain expertise — Experience working with clinical data workflows, regulatory requirements, or other highly regulated environments, with the ability to translate complex processes into clear acceptance criteria.

Responsibilities

Own and prioritize the product backlog, defining and communicating product vision, user stories, and roadmap in alignment with client needs and business objectives
Lead Agile ceremonies including sprint planning, stand-ups, reviews, and retrospectives in collaboration with engineering and QA teams
Serve as the primary liaison between clients, internal stakeholders, and cross-functional teams — gathering requirements, resolving issues, and maintaining alignment throughout the development lifecycle
Translate complex clinical data workflows, regulatory requirements, and operational needs into clear, testable acceptance criteria
Partner with data and engineering teams to support AI/data-driven product decisions, leveraging SQL and cloud data platforms for analysis and validation
Conduct discovery sessions with client and internal teams — from end users to C-suite — to define requirements and drive solution alignment
Maintain and improve internal tooling supporting clinical data workflows, including document management, metadata storage, and data extraction capabilities
Ensure all product development activities adhere to regulated software development standards
Utilize Azdo, Confluence, and Lucid (or equivalent tools) to manage the full product lifecycle in a Scrum/Kanban environment