Associate Director, CMC Portfolio Management

About the role

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.

Qualifications & Requirements

• Bachelors degree required in a technical or scientific related discipline and 10+ years professional work experience in the pharmaceutical or biotech industry; or Masters degree with 8+ years of work experience; or Doctorate degree with 4+ years of work experience in same disciplines.
• Note: Higher education may compensate for years of experience; years of experience may compensate for education
• Accreditation in a project management or process improvement discipline highly preferred (e.g. Project Management Professional, LEAN Six Sigma, etc.).
• 4+ years Project Management experience, including leadership of a cross-functional team required. Must be able to demonstrate knowledge of project management principles. Ability to work independently and represent sound strategies is required.
• Must have clear leadership skills that minimally include: strong written and effective interpersonal communication; capability to clearly present, influence, and logically justify proposals; sound judgment; negotiation and conflict management; effective communication across cultures and disciplines; relationship building and fostering teamwork; and training experience.
• Job requires knowledge of the drug development process.
• Cross-functional and global project team leadership experience required.
• Expertise in the tools and techniques of Project Management and/or Business Excellence (e.g., MS Office software, MS Project, Qlikview, Spotfire, etc.) required.
• CMC experience required.

Key Stakeholders

• Development project program directors/PPDST Co-Chairs, Asset PMTs, PPDST/AST development team representatives, Dev.
• Sci.
• Business Operations, Dev.
• Sci Finance, and CMC Portfolio Management group.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless anduntil paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.