Join a Legacy of Innovation 110 Years and Counting!
With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group's 2025 Vision to become a \"Global Pharma Innovator with a Competitive Advantage in Oncology,\" Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.
This position leads Project Management Office and Business Excellence (PMO/BE), the strategic planning and implementation group within CSPV. The Director PMO/BE manages DSI CSPV's strategic projects, including process improvements, and leads teams responsible for Strategic Partnership and Alliances and Global PV Intelligence and Strategy; including activities, staffing, processes, and interdepartmental projects involving PV sub functions. This position collaborates within global PV, CSPV, global teams, and interdepartmental teams and interacts with CROs, vendors, and partners. This level manages escalated issues and handles PV operational process and procedure issues, escalating to senior management as needed; and participates in hiring, compensation and personnel management decisions. Responsible for identifying and solving business issues and problems, designing business solutions that meet CSPV's needs.
Sub-Team Management: Overall accountability for supporting CSPV's strategic needs. Oversee and manage team leads responsible for; Strategic Partnership and Alliances; Global PV Intelligence and Strategy. Responsible for managing team workload and addresses issues escalated by the team leads. Review performance metrics and reports up to CSPV leadership and DSI leadership. Understand the critical success factors for the PMO/BE Group. Escalate issues and develops resource strategy with senior management as necessary.
Project Management: Responsible for planning, managing, and coordinating projects within CSPV. Prepare business requirements and generate documentation for Request for Information (RFI) and Request for Proposal (RFP) documents. Evaluate RFI and RFP responses and recommend a solution. Review \"quick-hit\" projects to ensure that they provide immediate benefit with little cost, risk, or need for coordination. Review the principles, constraints and assumptions for proposed projects. Deliver the project according to plan within contracted time frame and budget, meeting quality standards. Plan projects by producing realistic project plans and estimates. Manage the delivery of all work products against plan. Manage CSPV acceptance and understanding of scope and deliverables. Determine the critical success factors for the engagement. Delegate work to appropriate project resources, giving project resources the authority to make decisions. Report progress against budget and time frames to CSPV Leadership. Monitor and manage scope change requests. Work closely with CSPV Leadership to drive projects toward achieving the intended business results.
Business Excellence: Help to identify the business areas in greatest need of change using client needs, best practices, and benchmark performance measures. Understand and support CSPV and DSI leadership vision. Direct and coordinate the gathering of business requirements through a variety of techniques (e.g., workshops, work sessions and interviews). Facilitate process mapping and design workshops. Review high-level and detailed business process designs for scope adherence. Review and present gap analysis highlighting current state, future state, CSPV needs, and best practices. Facilitate discussions to identify root causes for operational and quality issues. Identify performance metrics for current-state business processes. Establish performance goals for future-state business processes based on CSPV needs, best practices, and benchmark performance measures. Conduct impact analysis of process redesign on existing organization roles, principles, and technical infrastructure and guide others to understand the impact.
Management Strategy and Goals: Develops PV goals, continued compliance and strategy for process improvement initiatives with senior management and PV management team.
Qualifications Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Qualified candidates must have a Bachelor's degree from an accredited college or university; Bachelor's degree in nursing, pharmacy, life sciences, health care or related field
Master's degree in life sciences or MBA preferred
Minimum of ten (10) years of project management experience
Minimum of eight (8) years of business process analysis/design experience
Minimum of eight (8) years leadership/management experience
Minimum of two (2) years of Drug Safety/Pharmacovigilance experience, including both investigational and marketed products
Knowledge of FDA regulations, clinical and safety databases
Familiarity with Good Clinical Procedures (GCP) and Good Pharmacovigilance Procedures (GVP)
PMI's PMP certification preferred
Prosci or ACMP certification preferred
Six Sigma certification preferred
Creates a culture of compliance for the function: works cross-functionally to identify risks and trends for the function.
Owns operational strategic plans, defines and manages priorities within the function and drives implementation.
Identifies issues independently, thoroughly understands cause of issues, recognizes functional and global impact, and oversees implementation of solutions.
Uses advanced scientific knowledge to influence PV processes and provide cross-functional leadership.
Interfaces, collaborates and negotiates with internal and external stakeholders to ensure successful results and resolution to complex issues.
Drives timely management decisions, appropriately shifts functional timelines, resources and priorities to address regional priorities.
Applies clinical trial knowledge to promote efficiency and compliance for assigned projects within the function with both internal and external stakeholders.
Knowledge of applicable global pharmaceutical legislation, specifically FDA, EMA and ICH safety reporting regulations, Good Clinical Practices, Good Vigilance Practices, patient privacy laws and other applicable local regulations.
Ability to define and monitor KPIs to achieve optimal performance
Ability to extract and make transparent key information from different fields to prepare decisions by CSPV leadership
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Director, PV Project Management Office & Business Excellence
City Basking Ridge
Functional Area CSPV
State New Jersey
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.