(Associate) Director, Project Management

Position

(Associate) Director, Project Management

Direct Report

Position Summary

Under the I-Mab US office, this role will manage new drug development projects (pre-clinical through Phase 1 and/or 2). This role will be a key leader liaison between the China PMO and US Clinical Development team.

Key Responsibilities

  • Lead the cross-functional efforts across US and China to integrate competitive intelligence, clinical science, and translational medicine to guide development plans, publications, and investor relations
  • Lead the development of project strategies and high-quality project plan (identify timeline, milestones, interdependencies, resource utilization, risks, and actions) through collaboration with project teams and relevant functions
  • Manage and track program progress both at project and program level. Identify all issues related to scope, timeline, and budget, both cross-project and cross-functional, including outsourced activities. Work proactively with manager and the project team to resolve issues and ensure timely execution of deliverables
  • Serve as the point of contact on all operational aspects of assigned project(s); develop and maintain working relationships with cross-function project teams; resolve conflicts and issues within teams
  • Support the project teams through implementation of strategic and operational plans while tracking progress towards goals
  • Maintain all project team related documents, including project action items, decisions and issues derived from project team interactions
  • Ensure timely, accurate and comprehensive project and program information is available to US Site Head and the broader global organization
  • Facilitate project development reviews, recommend action plans and ensure follow-up by management to achieve program/project objectives
  • Responsible for the smooth transitions between action points, from initiating IND through product launch and full life cycle management, from early to late-stage development
  • Support quarterly forecasts, manage scope, timeline, and financial changes through tracking variances at the program level
  • Escalate issues when necessary and notify senior management and governance bodies of risks and outcomes when appropriate

Qualifications

  • Master’s degree in relevant field required; Ph.D. preferred
  • 5+ years’ experience working in early clinical development stage in biotech and/or pharmaceutical industry required
  • Excellent interpersonal, communication (written and verbal) and negotiation skills
  • Experience working in multi-cultural, multi-lingual environment
  • Good understanding of the clinical, regulatory, and commercial requirements for early and late stage drug development
  • Knowledge of clinical operations and the regulatory process; knowledge of global drug development, registration, and market launch requirements
  • Proven ability to develop and implement cross-functional global drug development plans (GDDP), including strategic assessment of budgets and timelines
  • Thorough understanding of each functional area’s role and contribution to the development process
  • Solid computer skills with Microsoft Suite, including MS Project, Word, Excel, PowerPoint, and Outlook
  • PMP certification preferred