Sr. Manager, Planisware Process & Data Standards Lead

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 Planisware Process & Data Standards Lead is responsible for driving strategic governance, business process standardization, and data integrity for the Planisware platform across Global Clinical Business Operations and R&D. This role leads functional governance through the FCAC (Functional Change Advisory Committee), oversees change control, and ensures consistent application of data governance practices, including master data management via the Planisware Data Dictionary. The position plays a central role in training, stakeholder engagement, backlog prioritization, and vendor coordination. Success in this role requires strong leadership in cross-functional process alignment, system development oversight, and a strategic mindset focused on quality, compliance, and user enablement.

Essential Functions:

Lead standardized process development and governance for Planisware.
Oversee change management and chair the FCAC.
Own data quality, data dictionary (MDM), and governance frameworks.
Drive cross-functional training and enablement strategies.
Coordinate system development priorities and manage third-party vendors.

Requirements:

Education
Bachelor’s degree in Life Sciences, Business Administration, Information Systems, or a related field is required.
An advanced degree (e.g., MBA, MS, or related graduate degree) is preferred.
Professional certifications in Project Management (e.g., PMP), Lean Six Sigma, Change Management (e.g., Prosci), or Data Governance are a strong plus.

Experience
Minimum 7 years of experience in clinical development, R&D operations, system governance, or data/process management within the pharmaceutical, biotech, or life sciences industry.
At least 3 years of hands-on experience with Planisware or similar enterprise projects and portfolio management (PPM) systems.
Proven experience leading process governance, change management, and data governance initiatives in a regulated (GxP/21 CFR Part 11) environment.
Strong track record in cross-functional collaboration, stakeholder engagement, and training/enablement activities for system adoption and process standardization.

Technical Skills
Strong knowledge of Planisware functionality, including configuration, business process mapping, and system governance.
Understanding of project and portfolio management (PPM) processes and tools, especially in clinical development and R&D environments.
Experience with User Requirements Specifications (URS) development and version control processes.
Familiarity with data governance principles, including master data management (MDM) and metadata standards.
Proficiency in interpreting and applying data dictionaries, business rules, and standardized data definitions across systems.
Working knowledge of change control processes, including functional change evaluation and documentation practices.
Experience with system validation, including knowledge of compliance standards such as 21 CFR Part 11, GxP, and audit readiness.
Competence in tools like JIRA, Confluence, or similar platforms for backlog, change tracking, and collaboration.

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
• Conci