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Kyowa Kirin, Inc.- U.S. · 7 hours ago

Sr. Manager Global Development Organization System Tech Lead- Planisware

Princeton, NJ

Full-time

Hybrid

Senior Level

$155K/yr - $170K/yr

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines. The System Technical Sr. Manager is responsible for technical leadership and oversight of Planisware and all Global Development Operations systems, ensuring systems are integrated, optimized, and aligned with clinical development strategies.

Pharmaceuticals

H1B Sponsor Likely

Responsibilities

Own the technical roadmap and configuration of Planisware and GDO systems

Act as the official Planisware champion

Lead integration and performance enhancement efforts across platforms

Oversee APIs, data pipelines, and ensure standardization of data definitions

Work with product managers, system owners, and other stakeholders to align system capabilities with business needs

Support CRO onboarding and data compliance efforts

Ensure regulatory compliance and support audits and validation efforts

Drive innovation and ongoing enhancement of user experience and operational efficiency

Qualification

Planisware expertiseSystem integrationData managementClinical systemsCloud & InfrastructureProject managementStakeholder communicationRegulatory complianceContinuous improvementProgramming/scriptingCross-functional collaboration

Required

Bachelor's degree in computer science, Information Systems, Engineering, Life Sciences, or a related technical field is required

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

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

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

Preferred

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

Working knowledge of SQL, and familiarity with Python, R, or other data-related languages preferred

Benefits

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

Company

Kyowa Kirin, Inc.- U.S.

Kyowa Kirin is a global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines.

Founded in 1949

Princeton, New Jersey, US

501-1000 employees

https://kkna.kyowakirin.com/

H1B Sponsorship

Kyowa Kirin, Inc.- U.S. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (1)

2022 (1)

2021 (1)