Product Manager, Clinical Development Platforms

General Description:

The Product Manager is responsible for product vision, strategy, roadmap planning, requirements, delivery support, adoption, and continuous improvement throughout the product lifecycle. The role works closely with business stakeholders, engineering, data, AI, UX, and quality teams to deliver digital solutions that improve efficiency, decision-making, compliance, and user experience across the clinical development lifecycle.

The Product Manager serves as the voice of the customer and business, translating complex workflows and needs into scalable product capabilities while ensuring alignment to organizational goals and measurable business outcomes.

The ideal candidate combines strong product leadership with the ability to learn and navigate complex clinical development workflows. They can frame problems, build alignment, understand end-to-end user journeys and system dependencies, translate business and user needs into development-ready product direction, and guide AI-enabled or workflow-automation products in a regulated environment. For China hiring, direct clinical-development or protocol-authoring experience is valuable but not required. Candidates may bring transferable experience from healthcare, life sciences, medical technology, regulated enterprise software, quality or compliance platforms, scientific or medical content solutions, or other complex data- and workflow-intensive environments. Success requires strong product fundamentals, systems thinking, requirements quality, learning agility, and cross-functional leadership. The role requires sufficient technical and data fluency to make informed product decisions, but does not replace UX/Design, Architecture, Data, AI, Engineering, Quality, or Delivery specialists.

Essential Functions of the Job:

Core Product Management Responsibilities (70%)

Product Strategy and Vision

• Define and maintain product vision, strategy, roadmap, and success metrics.
• Partner with business stakeholders to identify opportunities, pain points, and desired business outcomes.
• Conduct discovery activities, including stakeholder interviews, workflow analysis, current-state and future-state assessments, and end-to-end understanding of users, personas, journeys, pain points, and desired outcomes.
• Partner with UX/Design to translate discovery insights into detailed journey maps, service-experience designs, prototypes, and usability validation; the Product Manager provides product context and decisions rather than independently owning the design discipline.
• Develop product roadmaps based on business value, strategic priorities, risk, complexity, dependencies, and resource constraints.
• Lead prioritization of product capabilities, features, enhancements, and enabling investments.
• Create and maintain business cases and value hypotheses for product investments.
• Assess market and technology trends, vendor solutions, and build-versus-buy opportunities.
• Establish product success measures and track adoption, value realization, user satisfaction, and operational impact.

Product Definition and Requirements

• Translate business needs into clear product requirements, workflows, use cases, business rules, and acceptance criteria.
• Ensure requirements are complete, testable, traceable, and ready for development.
• Facilitate product decisions, prioritization, and scope tradeoffs across stakeholders.
• Define product boundaries and identify business, workflow, system, integration, and data dependencies, including upstream and downstream impacts, at the level needed to make product and prioritization decisions.
• Apply systems thinking to understand how users, decisions, workflows, information, and products interact across the clinical-development ecosystem, while partnering with technical specialists on detailed solution design.
• Collaborate with technical teams to evaluate solution options and make informed product decisions.
• Participate in backlog refinement, release planning, roadmap reviews, and product governance checkpoints.
• Ensure alignment between business objectives, approved scope, and delivered product capabilities.

Product Lifecycle Management

• Support products throughout discovery, workflow analysis, validation, design, development, release, adoption, support, and continuous improvement.
• Own product vision, roadmap, prioritization, requirements quality, acceptance criteria, stakeholder alignment, release-scope definition, and measurable outcomes.
• Partner with business stakeholders on adoption, change management, communications, training, and value realization.
• Establish structured mechanisms for post-release feedback, support intake, backlog triage, and product learning.
• Monitor product performance and identify opportunities to improve outcomes and user experience.
• Facilitate release readiness with business, quality, delivery, and technical teams, ensuring that required activities have clear owners.
• Maintain alignment and communicate product decisions throughout planning and delivery.

Product Governance and Cross-Functional Leadership

• Establish clear product decision rights, including who recommends, contributes, approves, is informed, and serves as the escalation authority.
• Identify and manage product risks, assumptions, business dependencies, and cross-product impacts.
• Partner with Technical Leads and Architects on solution options, feasibility, non-functional requirements, technical dependencies, and risks; Technical Leads and Architects own detailed solution architecture, service architecture, APIs, integration patterns, and implementation design.
• Partner with Project, Program, or Delivery Management on integrated plans, schedules, RAID management, release coordination, and cross-team follow-through.
• Influence cross-functional teams without formal authority and communicate effectively with business and executive stakeholders.
• Produce fit-for-purpose product artifacts, including discovery summaries, stakeholder maps, workflows, use cases, PRDs, roadmaps, decision logs, dependency maps, release scope, and product metrics.

AI-Enabled Product Innovation

• Identify opportunities to use AI, including generative and agentic AI, automation, analytics, and decision intelligence to improve user outcomes and productivity.
• Define AI use cases, intended use, human-in-the-loop workflows, business requirements, user controls, evaluation criteria, measurable outcomes, and adoption needs for AI-enabled features.
• Collaborate with Data Science, AI, Engineering, Architecture, Quality, and domain experts to deliver responsible and measurable AI capabilities; technical teams own detailed orchestration, model and tool integration, data pipelines, production architecture, security, and reliability.
• Define expected outputs, validation approaches, quality criteria, representative test scenarios, and human review expectations.
• Use AI-assisted methods to accelerate discovery synthesis, requirements critique, workflow analysis, prototyping, and identification of gaps, while retaining human accountability for product decisions.

Clinical Development Domain Responsibilities (20%)

• Develop and demonstrate the ability to rapidly build a strong understanding of clinical development, clinical operations, regulatory, safety, data management, medical writing, and related business processes relevant to the assigned product portfolio.
• Partner with R&D stakeholders to understand clinical workflows, operating models, user needs, decision points, data needs, and compliance expectations.
• Translate complex clinical, scientific, and operational processes into scalable digital-product capabilities.
• Collaborate across functions to improve process efficiency, quality, compliance, traceability, and user experience across the clinical development lifecycle.
• Support digital transformation initiatives that improve planning, execution, oversight, documentation, and decision-making.
• Understand clinical information and logical data flows at a product level, including what information is needed, where it originates, who consumes it, the decisions it supports, and the upstream/downstream impact of change; partner with Data and Engineering teams on detailed schemas, mappings, transformations, lineage, pipelines, and technical interconnectivity.
• Apply appropriate product controls for regulated or validated solutions, including auditability, role-based access, data integrity, testing evidence, and controlled release expectations.

Relevant Domain and Transferable Experience (10%)

Experience in one or more of the following clinical or adjacent areas is desirable. Candidates are not expected to have experience across every area, and directly comparable experience may be considered:

• Clinical protocol authoring or digital protocol solutions
• Study design platforms and Schedule of Activities
• Clinical document management or medical writing platforms
• CRF design, clinical data collection, or study setup automation
• Protocol amendments, version management, comparison, lineage, or change-impact assessment
• Workflow automation, structured content, traceability, or metadata management
• AI-assisted content authoring, document intelligence, extraction, or review
• Clinical-trial technology ecosystems and interconnected downstream workflows
• Healthcare, hospital, patient-services, medical technology, or health-data platforms
• Regulated enterprise software supporting quality, safety, compliance, auditability, or controlled workflows
• Scientific, medical, regulatory, legal, or other structured-content and document-intelligence platforms
• Complex workflow products involving multiple personas, approvals, traceability, versioning, integrations, or upstream-to-downstream dependencies
• AI-enabled enterprise products requiring human review, quality evaluation, explainability, governance, or measurable operational outcomes

Cross-Functional Role Boundaries

• Product Manager: Owns the business problem, users, desired outcomes, product vision, roadmap, priorities, product requirements, scope, acceptance criteria, stakeholder alignment, product decisions, and measurement of value.
• UX/Design: Owns UX research and design methods, detailed customer-journey and service-experience design, interaction design, prototyping standards, and usability practice. The Product Manager participates and provides product direction.
• Technical Lead / Architect: Owns technical design, solution and service architecture, APIs, integration patterns, non-functional requirements, technical dependencies, technical risks, and implementation decisions. The Product Manager participates in trade-offs but is not expected to author technical designs independently.
• Data / AI / Engineering: Own detailed data architecture, schemas, mappings, transformations, pipelines, lineage, AI orchestration, model and tool integration, production engineering, security, scalability, and reliability. The Product Manager defines product intent, requirements, controls, evaluation criteria, and outcomes.
• Project / Program / Delivery Management: Owns the integrated schedule, RAID management, delivery coordination, status, governance follow-through, and cross-team escalation when a dedicated delivery role is assigned. If these responsibilities are assigned to the Product Manager, portfolio scope and strategic expectations should be adjusted accordingly.

Qualifications

Required Qualifications

• Bachelor's degree in Computer Science, Health Sciences, Life Sciences, Engineering, Business, or a related field.
• Five or more years of Product Management experience delivering enterprise software or digital products.
• Experience partnering with business stakeholders to define product strategy, roadmaps, requirements, and measurable outcomes.
• Strong discovery, end-to-end journey and workflow analysis, systems thinking, prioritization, facilitation, and problem-solving skills.
• Experience translating user needs into product requirements, use cases, business rules, acceptance criteria, and delivery-ready work.
• Excellent verbal, written, presentation, and stakeholder-management skills.
• Proven ability to influence cross-functional teams without direct authority.
• Experience working in Agile or iterative product-delivery environments.
• Strong analytical judgment and the ability to balance strategic thinking with execution focus.
• Demonstrated learning agility and ability to acquire domain knowledge quickly through stakeholder discovery, workflow analysis, source documentation, and collaboration with subject-matter experts.

Strongly Preferred Qualifications

• Experience in healthcare, life sciences, biotechnology, pharmaceuticals, medical technology, clinical research, regulated enterprise software, or another complex data- and workflow-intensive environment. Direct clinical-development experience is preferred but not required for China hiring.
• Experience supporting Clinical Development, Clinical Operations, Regulatory, Safety, Medical Writing, Data Management, or related functions is preferred. Comparable experience supporting healthcare, quality, compliance, scientific content, regulated operations, or interconnected enterprise workflows may be considered.
• Experience delivering GxP, validated, or otherwise regulated digital products is desirable; experience with products requiring auditability, traceability, controlled change, data integrity, privacy, security, or formal quality controls may be considered transferable.
• Experience defining or delivering AI-enabled, including generative or agentic AI, analytics-driven, decision-support, or workflow-automation products, with an understanding of human-in-the-loop workflows and measurable product outcomes.
• Experience collaborating with UX/Design, Data, AI, Analytics, Architecture, Quality, and Engineering specialists on complex enterprise products, with clear understanding of cross-functional ownership boundaries.
• Experience managing cross-product dependencies, integrations, traceability, versioning, or upstream-to-downstream workflows.

Nice to Have

• Experience with protocol authoring, study design, or Schedule of Activities solutions.
• Familiarity with clinical-trial technology platforms and digital R&D ecosystems.
• Experience with clinical document automation or intelligence solutions.
• Knowledge of clinical data standards, structured protocol models, or metadata management.
• Experience with AI-assisted authoring, decision support, content extraction, or document intelligence.
• Familiarity with Veeva, Medidata, Oracle, IQVIA, or related clinical-technology ecosystems.
• Advanced degree in a relevant business, technology, clinical, scientific, or health discipline.

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