Sr Manager, Strategic Process Excellence Lead - OED Development Operations

Purpose:
The Sr Manager Process Excellence Lead (PEL) is accountable for continually optimizing Oncology Early Development business processes (including clinical operations, data management, statistical programming and medical monitoring), that will identify and define process improvement opportunities and assure accurate process documentation, appropriate training and delivery mechanisms, content creation, compliance, and system implementation.
The Sr Manager PEL will identify, plan, and execute opportunities to drive innovative process excellence and deliver on organizational strategies, goals, and objectives. They will act as primary point of contact for continuous process improvement and change management activities for OED and communicate key information and updates to appropriate leadership, function heads and senior leadership for alignment and endorsement.
Responsibilities:
Serves as an Oncology Early Development (OED) Development Operations’ process expert, knowledge leader and owner of process health. Is accountable for process performance oversight, process related decision-making, and all process related maintenance activities. Additionally, partners closely with functional area management and experts to streamline and optimize process content, outputs, and quality.
Proactively defines metrics and KPIs for assigned process areas with a goal of measuring process health and compliance. Strategically forecasts and manages plans/updates for assigned processes in collaboration with leaders and function heads, and others as needed, utilizing knowledge of current and future business environment.
Responds to process-related questions, alerts team and leadership of trends, proactively identifies knowledge gaps and prepares plans for remediation.
Leads and delivers continuous process improvement for assigned business process area(s) by strategically identifying pain points and opportunities for efficiency.
Lead and / or participates in working teams to defines processes drive implementation including updates to global operating procedures, functional requirement specifications, training materials and process design documentation as needed.
Own the governance and maintenance of OED operating models, process frameworks, and knowledge resources, serving as the primary resource for operational guidance and interpretation of established processes, standards, and ways of working.
Monitors and analyzes operational performance and compliance metrics and KPIs to demonstrate process effectiveness and quality, identify areas of improvement and recommend solutions. Participates in process aligned initiatives to drive transformational improvements and makes strategic, aligned decisions via relationships with cross-functional stakeholders. Leverages process improvement tools to identify and implement countermeasures to improve efficiency, quality, and compliance.
Displays original thinking and creativity, meets challenges with resourcefulness, generates suggestions for improving work, and effectively presents ideas and information.
Ensures sustainability of all improvements post-implementation by partnering with cross-functional team leaders and process owners to define the optimal performance measurements to track and measure success over time.
Upholds organizational values and demonstrates sound business ethics, works with integrity and ethics in all situations, and always treats others with respect and consideration. Takes responsibility for actions, reacts well under pressure, follows through on commitments, and demonstrates consistency between words and actions.
Bachelor’s degree with 8+ years in Pharmaceutical, Healthcare, or regulated industry; 6+ with Masters, 4+ with PhD (required).
5+ years process management and continuous improvement experience preferred.
Strong project management skills with the ability to be resourceful and adapt to situations with unknowns, but still be able to drive progress while communicating and delivering presentations with impact, experience in the process area of responsibility (preferred).
Experience with use and/or development of metrics to drive risk-based business decisions and/or improvements including working with data sets to draw out conclusions and business insights. Strong business insight and ability to assess trends, complex data sets, generate robust business cases and impact analysis.
Recognized leader and expert in standard business procedures, including project and change management practices, with robust understanding of GxP.
Strong organizational, team building, and communication skills. The ability to work and navigate within a complex matrixed organization with a track record of delivering impactful, transformative change (required).
Demonstration of successful stakeholder management through communication and leadership with broad business orientation.
Solid interpersonal and influencing skills to ensure buy in at various levels and within and across various functions of the organization who can collaborate to drive better outcomes.
Comfortable with out of the box thinking and challenging status quo.
Understanding of efficiency principles such as Lean/Six Sigma; Black belt, Business Process Management Professional (BPMP) Certificate and/or similar recognized industry continuous improvement programs preferred.

Employment type
Full-time

Work arrangement
Hybrid