Sr. Manager Global Development Organization System Tech Lead- Planisware

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary:

The System Technical Sr. Manager (Lead) is responsible for technical leadership and oversight of Planisware and all Global Development Operations (GDO) systems, including CBIS, Development DWH, LSAT, and DDWorks. This role ensures systems are integrated, optimized, and aligned with clinical development strategies. Key responsibilities include:
• System Leadership: Own the technical roadmap and configuration of Planisware and GDO systems. Act as the official Planisware champion.
• System Integration & Optimization: Lead integration and performance enhancement efforts across platforms. Oversee APIs, data pipelines, and ensure standardization of data definitions.
• Cross-functional Collaboration: Work with product managers, system owners, and other stakeholders to align system capabilities with business needs. Support CRO onboarding and data compliance efforts.
• Governance & Compliance: Ensure regulatory compliance and support audits and validation efforts.
• Continuous Improvement: Drive innovation and ongoing enhancement of user experience and operational efficiency

Requirements:

Education
Bachelor’s degree in computer science, Information Systems, Engineering, Life Sciences, or a related technical field is required.
A master’s degree in a relevant field (e.g., Information Technology, Data Science, Bioinformatics, or Business Administration) is preferred.
Additional certifications in Project Management (e.g., PMP), Planisware, Data Governance, or Agile methodologies are a plus.

Experience
Proven experience in enterprise system management, preferably in life sciences or clinical development.
Expertise in Planisware or similar PPM tools and data integration strategies.
Strong cross-functional collaboration, project management, and stakeholder communication skills.
Familiarity with regulatory, quality, and data governance standards.

Technical Skills
Planisware expertise: Strong hands-on experience with Planisware system architecture, configuration, administration, and integration.
System integration: Proficiency in integrating enterprise systems using APIs, middleware, and ETL/data pipelines.
Data management: Knowledge of data modeling, data warehousing, and master data management (MDM) principles.
Clinical systems: Familiarity with clinical trial operations and systems such as CBIS, LSAT, DDWorks, and Development Data Warehouse.
Programming/scripting: Working knowledge of SQL, and familiarity with Python, R, or other data-related languages preferred.
System validation & compliance: Experience with CSV (Computer System Validation), 21 CFR Part 11, GxP, and other regulatory standards.
Project management tools: Experience using JIRA, Confluence, or similar platforms to manage backlog, testing, and documentation.
Cloud & Infrastructure: Understanding of cloud-based solutions (e.g., AWS, Azure) and SaaS/PaaS environments.

Working Conditions:

Requires up to 25% of domestic and international travel

The anticipated salary for this position will be $ 155,000 to $ 170,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company matching
• Discretionary Profit Sharing
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Long-Term Incentives
• Life & Disability Insurance
• Concierge Service
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and ben