Position Overview :
We are seeking a Technical Product Owner (TPO) with a strong background in Agile delivery, cloud engineering, and scientific computing to support Clinical Pharmacology and Pharmacometrics teams . This role requires a blend of technical depth, agile product management, and domain awareness in Clinical Pharmacology and regulatory data standards.
Key Responsibilities :
- Act as the primary liaison between business stakeholders, scientists, and technical teams, translating Clinical Pharmacology needs into technical requirements and product features.
- Define, prioritize, and manage the product backlog for HPC and scientific computing platforms.
- Lead Agile ceremonies including sprint planning, backlog grooming, daily scrums, sprint reviews, and retrospectives.
- Collaborate with cloud engineering, DevOps, and data teams to deliver scalable, secure, and compliant cloud-based solutions.
- Define and track product KPIs, ensuring continuous improvement in usability, performance, and compliance.
- Partner with R&D teams to support integration of pharmacology tools (Phoenix WinNonlin, Pirana, Monolix, MATLAB, NONMEM) with AWS HPC infrastructure.
- Collaborate with Quality and Compliance teams to ensure 21 CFR Part 11, GxP, and data integrity adherence.
- Work with data standardization and validation tools such as Pinnacle 21 for CDISC compliance.
- Manage Jira boards, workflows, and reporting for transparent delivery tracking and stakeholder communication.
- Facilitate cross-functional alignment with program managers, business analysts, and cloud architects.
- Support roadmap development and budget planning for product evolution.
Required Skills & Experience :
Agile & Scrum : 5+ years as a Product Owner or Technical Product Manager in Agile / Scrum environments.Tools : Jira, Confluence, Azure DevOps (preferred), ServiceNow.Cloud & DevOps Exposure : AWS (EC2, S3, Batch, Lambda, CloudFormation) and CI / CD pipelines understanding.Domain Knowledge : Familiarity with Clinical Pharmacology, Pharmacometrics, and scientific data workflows.Regulatory Awareness : Working knowledge of CDISC standards (SDTM, ADaM) and data validation tools like Pinnacle 21.Hands-on experience with Pinnacle 21 Enterprise or Pinnacle 21 Community for validation of CDISC datasets.Ability to interpret Pinnacle 21 validation outputs and coordinate remediation with data management and programming teams.Desirable Skills :
Prior experience with scientific computing platforms, HPC workloads, or data governance solutions.Familiarity with data visualization and reporting tools (Spotfire, Tableau, Power BI).Exposure to Pirana, Phoenix WinNonlin, Monolix, or similar pharmacometric modeling tools.Education :
Bachelors or Masters degree in Computer Science, Bioinformatics, Life Sciences, or Biomedical Engineering.Certifications : Certified Scrum Product Owner (CSPO), AWS Cloud Practitioner, or SAFe PO / PM.(ref : hirist.tech)