Director/Sr Director, Program Management

Job Description:

The Director / Sr. Director of Program Management is a proactive and effective problem solver who is intellectually curious and works exceedingly well with others.  This role is responsible for coordinating and driving cross-functional activities required to advance a program from pre-clinical development through BLA submission.  The winning skill set includes working effectively and efficiently with cross functional groups such as non-clinical, clinical, technical development, regulatory, manufacturing and commercial planning.  The Director / Sr. Director of Program Management serves to help establish and execute program strategy and activities, integrating cross-functional input, synthesizing team recommendations, and directing program advancement on time and on budget.  Lastly, the Director / Sr. Director of Program Management is expected to maintain consistent, multi-level communication with Development Team Members, Senior Management, and the Executive Team, including the CEO.  This role will report into Global Head, Program Teams, who reports into the CEO.

Responsibilities:

  • Partner with cross-functional leaders to develop comprehensive product development and lifecycle management plans (e.g., Non-Clinical, Clinical, CMC, Regulatory) that optimize value, time, resources, risk, and alignment with business objectives
  • In collaboration with cross-functional team:
    • Implement product development and lifecycle management plans
      • Identify and manage critical path activities and resources
      • Identify and manage interdependencies and hand-offs
      • Identify and proactively mitigate roadblocks
      • Identify and document risks, likelihoods, severities, and key mitigations
      • Lead contingency planning
      • Capture and communicate progress; escalate potential delays with proposed solutions
    • Direct programs through corporate governance to ensure that:
      • Projects have adequate resources and technical expertise to meet strategic objectives
      • Issues are raised, discussed, and resolved in a timely manner
      • Project teams receive management decisions in a timely manner
      • Programs adhere to agreed-upon scope, timelines, resources, and budget
    • Communication
      • Responsible for project team documentation, including agendas, minutes, timelines, development plans, discussion aids, risk logs, and decision logs
      • Responsible for facilitating Core Development Team (“Core Team”) and regulatory and CMC Sub-Teams Meetings, respectively
      • Present project updates, strategic issues, options, and recommendations to various R&D leadership teams, as well as the Executive Team, including the CEO

Requirements:

  • Proven ability to manage complex, cross-functional development projects with multiple scenarios
    • Expertise using Project Management software to manage timelines, resources, risks, and costs
    • Ability to rapidly integrate new information into existing plans
  • Ability to influence across all levels of the organization
  • In-depth knowledge of global, early-stage, biologic drug development
  • Provide Senior Management and the Executive Team with timely, candid and accurate information, options, and recommendations
  • Prior experience working in a fast-paced, entrepreneurial, development-stage company
  • Ability to achieve business results with colleagues of diverse levels, functional expertise, skills, and priorities: effective as both a team player and a team leader
  • Maintain a clear focus on business objectives
  • Take a hands-on, “roll up your sleeves” approach
  • Drive, facilitate, track, anticipate, influence, and implement
  • Challenge the status quo where relevant
  • Resolve conflicts within the team and otherwise be a good “glue” type of person culturally
  • Think strategically and craft solutions
  • Undergraduate degree in a scientific, medical or business discipline. A postgraduate qualification (e.g., Ph.D., MBA, MS) will be a distinct advantage
  • PMP Certificate a plus
  • Knowledge of project management methodologies, concepts and techniques is required.
  • A minimum of 10 years of biopharmaceutical industry experience, with half in a Project Management function

Additional Information:

  • Please include a cover letter that highlights your qualifications that matches our requirements and send resumes to resumes@annexonbio.com.