Director/Sr Director, Program Management - Pharmaceutical

Location
94080, South San Francisco
Posted
Jun 05, 2019
Required Education
Masters Degree/MBA
Position Type
Full time

Summary

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.

Specific 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
  • Position reports to Global Head, Program Leader. 

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

Position Qualifications

  • 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