Associate Director, Project Management (JL19-192)

Summary of the Position

Catalyst Biosciences is seeking an Associate Director, Project Management (PM) in our South San Francisco office, reporting to the Vice President, Business Development. The position will be responsible for project planning and activity tracking for our pre-clinical and clinical drug development programs. The incumbent will be responsible for integrating cross-functional program activities and will work closely with senior management, project leadership and cross-functional teams. This is a key role that contributes to both the short-term tactical needs and longer-term strategy for company.

Responsibilities

  • Provide advanced PM support to complex drug development projects, including action item tracking, organization and communication of materials
  • Apply advanced PM principles and techniques to develop multiple project planning scenarios; identify, monitor and analyze business risks
  • Support project leadership by collaborating closely with each functional area to ensure projects are moving effectively toward milestones
  • Contribute to creation and management of PM budgets and resource estimates for functional area, provide oversight of resources
  • Inform senior management of operational, budgetary and resource concerns in a timely fashion
  • Assemble comprehensive Gantt charts including specific resource allocation for all pre-clinical and clinical-stage programs integrating cross-functional activities to validate the project plans
  • Review Gantt charts (or derivative PowerPoint charts) with team members on a regular basis to update, provide reminders, identify critical path items and develop action plans to solve critical issues
  • Provide and manage regular program-wide dashboards for each development program to senior management team
  • Partner with project leaders, manage preparation of program-wide development plans toward Regulatory approval, including Pre-clinical, Manufacturing, Clinical, Regulatory, Quality, Business Development and Finance management
  • Collaborate with Pre-clinical, Clinical and CMC sub-teams and other contributors to identify critical issues, critical path and project overlap
  • Identify program-related risks and work with teams to develop mitigation plans
  • Ensure consistent practices throughout all phases of the project life cycle
  • Apply best practices in the development, initiation, planning, execution, control and closing of projects

 

Qualifications/Skills Required

  • Master’s Degree or MBA required; PhD in life science discipline a plus
  • Minimum 7 years biotech/pharma industry experience
  • Minimum 5 years of PM experience on drug candidate advancement through Manufacturing, CMC and Clinical activities; Experience with protein/large molecule drugs required
  • Proven leadership skills, executive presence, maturity, emotional intelligence, attention to detail, excellent written and verbal communication, problem solving with various working assumptions, intangible variables and incomplete information
  • Strong experience facilitating project team meetings, cross-functional collaboration, communication and decision making and ensuring alignment with internal and external stakeholders
  • Training and experience in use of diverse PM tools, including MS Project and document management systems such as SharePoint, ShareFile, Box
  • Exposure to and/or participation in BLA approval process
  • Knowledge of Regulatory requirements, minimally FDA and EMA/MHRA; ROW a plus
  • PMP certification or equivalent required
  • Experience working on global project teams preferred
  • Demonstrated skills in Catalyst’s Core Competencies:
    • Leadership
    • Drive, Intensity, Enthusiasm
    • Goal Orientation/Commitment to Task/Follow-up
    • Teamwork
    • Attention to Quality & Detail
    • Decision Making & Problem Solving
    • Flexibility

 

Thank you for your interest in Catalyst Biosciences! You may apply for this position by sending your CV/resume to jobs@catbio.com, referencing requisition number JL19-192 in the subject line.