Responsibilities:
- Independently provide advanced project management support for multiple complex drug development and on-market LCM projects, including creation/maintenance of CMC technical plans in Asset Management Platform (AMP), PPDST roster management, and timeline swimlanes.
- Lead PPDST Team meetings (agenda, action items, discussions) and drive accountability to meet deliverables; develop planning scenarios; identify/monitor/analyze business risks; conduct root cause analyses and recommend corrective actions.
- Ensure functions have the right tools, reports, and data for accurate resource estimates.
- Support knowledge management communications (e.g., SharePoint/Team sites) for PPDST teams.
- Identify process improvement opportunities and manage cross-functional process improvement projects; convert goals to tasks; estimate and manage requirements; lead small teams and keep management informed of milestones.
- Apply advanced project management principles to coordinate and complete assigned goals; prioritize effectively.
- Advise peer Project Managers/PPDST Co-Chairs on monthly plan issues/timelines; provide change request data entry; define performance expectations and assess progress.
- Use project management tools for metrics collection, data analysis, guidelines/checklists, and process improvement.
- Serve as local expert for business procedures; recommend solutions; develop training/presentations; mentor junior staff.
- Build and maintain networks with internal/external stakeholders; facilitate high-performing teams; may manage Sr. Specialists; influence peer Program Managers.
Qualifications:
- Bachelorโs in technical/scientific discipline with 12+ years in pharma/biotech; or Masterโs with 10+ years; or Doctorate with 4+ years.
- 2+ years project management experience, including leadership of a cross-functional team; ability to work independently.
- Strong leadership and communication skills (written/interpersonal), presentation/influence/justification, judgment, negotiation/conflict management, cross-cultural communication, relationship building, teamwork, and training experience.
- Knowledge of the drug development process.
- Proficient in project management/business excellence tools (e.g., MS Office, MS Project, Qlikview, Spotfire).
- Preferred: project management/process improvement accreditation (e.g., PMP, Lean Six Sigma); cross-functional/global team leadership; CMC experience.