The Associate Director, CMC Portfolio Management leads with the development and maintenance of Chemistry, Manufacturing, and Controls (CMC) project plans for Product Presentation & Device Strategy Teams (PPDST) using standardized project management tools and processes. These CMC plans are used for decision making on drug development teams and across the R&D portfolio.  Responsibilities include maintaining accurate PPDST rosters, generation of timeline swim lanes, and scenario planning interacting with Program Development Directors and key external stakeholders within R&D/Ops/Commercial. Additional responsibilities include Early Biologics Excellence (EBE) pre-clinical timeline support. The candidate is expected to quickly excel at program management responsibilities and seek to establish themselves as a strategic leader of their teams and strong representative of the Development Sciences organization to senior leaders and cross-functional partners.

Responsibilities

• Independently provide advanced and extensive project management support to multiple complex (e.g. early-mid stage, requiring a device, etc.) drug development projects, including creation and maintenance of CMC technical plans in Asset Management Platform (AMP), PPDST roster management, and timeline swim lanes for relevant program reviews.
• Leads the PPDST Team meetings, including setting agenda topics, capturing action items, and driving discussions with PPDST members. Drives PPDST team accountability to meet project deliverables. Develops multiple project planning scenarios in collaboration with PPDST team members; identifies, monitors, and analyzes business risks. Recognizes when corrective action and planning are necessary and conducts root cause analyses (escalating recommendations to PPDST Team).
• Manage activities to ensure functions have the right tools, reports, and AMP data for accurate resource estimates. Supports organization/communication of knowledge management materials (e.g. SharePoint/Team sites, etc.) for PPDST teams.
• Independently identifies opportunities for improvement of departmental work processes and manages large and small cross-functional process improvement initiatives. Contributes to defining departmental vision and strategy. Converts departmental and cross-functional goals to tasks and coordinates activities to meet goals. Estimates and manages requirements to achieve defined objectives.
• Lead multiple process improvement teams through execution on defined objectives and keep management informed of progress and achieved project milestones. Apply advanced and extensive project management principles and techniques to the coordination and completion of assigned goals and tasks. Prioritize tasks with effective use of time.
• Support and advise peer Project Managers/PPDST Co-Chairs on monthly project plan issues and timelines for maintenance and information reporting. Provide data entry for change requests.
• Apply advanced project management tools for metrics collection and conduct advanced analysis of project data. Develop guidelines and checklists. Utilize and implement tools to identify novel solutions for metrics collection, data analysis and process improvement.
• Serves as local expert for business procedures and recommends solutions to R&D (Development Sciences, Regulatory, etc). Develop and provide advanced training courses, presentations, and guidance to foster best practices. Mentor junior staff on training, presentation development, and delivery.
• Establish and maintain strong network within department and external stakeholders. Utilize established organizational network to identify opportunities, gaps and synergies consistent with departmental strategy. Actively manages cross-functional and departmental team behaviors, mediates internal team disputes, and facilitates establishment of high performing teams. May manage Sr. Specialists and/or Program Managers within the department.
• Interacts with all levels of employees in support of project coordination. Effectively influences senior R&D leaders regarding project initiatives and direction. Defines performance expectations and assesses progress against plans, processes, and practices to determine effectiveness and areas for process improvement.