Director, Innovation Product Owner

AstraZeneca•Durham, NC

2d•Hybrid

About The Position

Redefine clinical trials through innovation. Join AstraZeneca's Emerging Technologies team to pioneer breakthrough solutions that accelerate therapeutic development, optimize global study delivery, and revolutionize Clinical Operations. As Director, Innovation Product Owner, you'll serve as the strategic catalyst between R&D IT, Clinical Development, senior leadership, and cross-functional partners, ensuring emerging technologies are adopted responsibly, compliantly, and with measurable impact. You'll operate at the nexus of product strategy, agile delivery, and regulatory compliance, translating powerful innovations (digital health, wearables, decentralized trials and AI-enabled applications) into practical, scalable solutions that drive business value and scientific breakthroughs. This role demands deep expertise in innovation product management, agile methodologies tailored to regulated environments, and proven track record to influence executive partners while navigating compsophisticatedanizational dynamics. You'll champion the end-to-end lifecycle of innovation products from ideation and roadmap development through deployment, continuous improvement, and governance, ensuring alignment with AstraZeneca's strategic priorities, regulatory obligations, and ethical innovation principles. You'll drive transformative improvements in clinical study delivery, operational efficiency, and patient outcomes while safeguarding the company's license to operate in a highly regulated environment. Success requires balancing innovation velocity with compliance difficulty, partner needs with technical feasibility, and strategic vision with tactical execution.

Requirements

Bachelor of Science in Computer Science, Engineering, Life Sciences, Health Informatics, or equivalent discipline (or equivalent experience)
Extensive experience (8+ years) in product management or product ownership, with a proven track record of delivering technology-enabled products or digital solutions in clinical research or healthcare
Deep expertise in agile delivery methodologies (Scrum, SAFe, Kanban) with demonstrated ability to apply these frameworks in complex, regulated environments
Strong understanding of emerging technologies applicable to clinical trials, including digital health, wearables, decentralized trials and AI-enabled applications
Proven experience in regulated industries (pharmaceutical, biotechnology, medical devices, or healthcare), with knowledge of ICH/GxP, FDA, EMA, or equivalent regulatory standards
Demonstrated ability to collaborate effectively with R&D IT, Clinical Development, and senior leadership teams, driving alignment and delivering strategic outcomes

Nice To Haves

Advanced degree (Master's or PhD) in Computer Science, Engineering, Life Sciences, Health Informatics, or related field
Recognized agile certifications (Certified Scrum Product Owner, SAFe Product Owner/Product Manager, or equivalent)
Experience with innovation governance frameworks, responsible innovation practices, and ethical technology principles
Hands-on experience with digital health technologies, clinical trial management systems (CTMS), electronic data capture (EDC), wearables, or decentralized trial platforms
Knowledge of clinical trial processes, clinical data standards (CDISC, SDTM, ADaM), and regulatory submission requirements
Experience with Lean Six Sigma or similar process improvement methodologies, including root cause analysis and continuous improvement initiatives
Proven track record of leading large-scale, transformative innovation initiatives from concept to deployment, with measurable business impact
Experience working with external technology vendors and partners, including contract negotiation, vendor management, and issue escalation
Strong understanding of data privacy regulations (GDPR, HIPAA, 21 CFR Part 11) and their implications for innovation product development
Expert reputation within the biopharmaceutical industry or innovation product management community, with thought leadership contributions (publications, speaking engagements, etc.)

Responsibilities

Drive Innovation Product Strategy & Transformation
Define product vision for emerging technology solutions in R&D Clinical Operations, aligning organizational goals with frontier innovations (digital health platforms, wearable devices, decentralized trial technologies, AI-enabled applications)
Build and own product roadmaps that prioritize high-impact use cases, balancing innovation velocity with feasibility and collaborator needs
Translate business challenges into actionable features, user stories, and acceptance criteria within agile frameworks
Identify transformative opportunities that redefine clinical study design, patient engagement, data capture, and operational efficiency
Champion experimentation by piloting emerging technologies and scaling proven innovations across global studies
Stay ahead of technology trends by integrating frontier solutions and industry best practices into product strategy
Lead Agile Delivery & Cross-Functional Collaboration
Apply agile methodologies (Scrum, SAFe, Kanban) tailored to regulated biopharma environments, delivering iteratively and compliantly
Partner with R&D IT and Clinical Development to co-create scalable innovation solutions aligned with enterprise architecture
Influence senior leadership by securing agreement, navigating organizational complexity, and driving technology adoption through strategic updates and executive engagement
Facilitate sprint planning and backlog refinement to ensure transparency and alignment across multidisciplinary teams
Act as the customer voice by synthesizing feedback from clinical operations and end-users to continuously enhance innovation products
Build strategic partnerships with external technology vendors, startups, and industry consortia to accelerate innovation
Enable Compliant Innovation Adoption
Ensure regulatory compliance with ICH/GxP, FDA, EMA standards by embedding validation strategies and risk mitigation throughout the product lifecycle
Collaborate with QA and Regulatory Affairs to establish governance frameworks that enable rapid, safe technology deployment
Develop comprehensive product documentation including validation plans, risk assessments, user requirements, and SOPs to support audit readiness
Champion responsible innovation by proactively addressing ethics, data privacy, security, and patient safety considerations (GDPR, HIPAA, 21 CFR Part 11)
Support regulatory inspections by providing expertise, documentation, and evidence of compliant innovation development and deployment
Pioneer industry-standard governance by shaping innovation frameworks in collaboration with regulatory bodies and industry leaders
Measure Impact & Drive Continuous Improvement
Define critical metrics to track product performance, user adoption, business impact, and compliance adherence
Analyze usage data and trends to identify optimization opportunities and drive Lean Six Sigma initiatives
Deliver measurable outcomes including efficiency gains, accelerated insights, improved trial enrollment, enhanced patient experience, and operational excellence
Monitor emerging trends by staying current with technology innovations, regulatory developments, and competitive landscape
Develop Talent & Foster Innovation Culture
Mentor product owners and cross-functional teams to build agile excellence and innovation literacy across the organization
Promote a culture of innovation, collaboration, and accountability by empowering teams to experiment, learn, and deliver exceptional results
Share knowledge and standard processes to contribute to the growth and capability-building of the Emerging Technologies team