Clinical Project Management, Dir/Sr. Director

Northern Chicago, Illinois
Feb 25, 2018
Required Education
Masters Degree/MBA
Position Type
Full time
Description Reporting to the Chief Medical & Scientific Officer this will be a highly visible position responsible for the management of activities across functions to ensure successful delivery of projects in line with corporate goals, milestones and within budget across a diverse portfolio of assets. ESSENTIAL JOB FUNCTIONS Essential Duties and Job Functions:
  • Develop project plans with established goals, milestones, timelines, and budget for clinical/medical and regulatory activities. Activities range from management of activities related to clinical development (e.g. protocols, clinical trials, investigator brochures), CRO budgets/oversight, regulatory submissions (sNDA, NDA, briefing documents), medical affairs, pharmacovigilance
  • Serve as the point-person for the Chief Medical & Scientific Officer and his reports for the status and delivery of clinical/medical and regulatory projects
  • Partner with function heads, external partners, and the project team to ensure project is on track and aligned with corporate goals.
  • Closely monitor and track project schedules toward milestones and issue status reports.
  • Anticipate, identify, and resolve discrepancies in project priorities, plans, and activities.
  • Develop and track project budgets, identify variances, anticipate scope changes, and communicate changes and issues that may impact the current project budget.
  • Partner with project team leaders to ensure that the development functions perform optimally within the framework of a specific project.
  • Directs highly complex project communications and ensures that all stakeholders are fully informed and knowledgeable of project activities and their status.
  • Schedules, coordinates preparation for Leadership Team meetings
  • Facilitates goal-setting ensuring alignment with company goals.
  • Due Diligence - participates in managing the functional review/assessment of potential opportunities, provides integration and project management support post-acquisition.
  • Prepare and present periodic updates at appropriate committee meetings.
  • Partner with partner alliance managers to support and promote communication between companies;
  • Address complex problems in which analysis of situations requires an evaluation of intangible variables.
  • Degree in life sciences, chemistry, business administration, or finance, with 8+ years successful project management track record in the biopharmaceutical /pharmaceutical industry.
  • MBA desirable
  • Experience in project management related to clinical trials, regulatory submission efforts with consistent track record of successful project delivery
  • Knowledge of drug development functional areas, including preclinical, clinical, regulatory affairs
  • Excellent communication and inter-personal skills
  • Expertise in preparing project plans and project/program presentations and updates

  • Integrity
  • Decisions & Judgment
  • Ownership & Initiative
  • Adaptability & Change Readiness
  • Teamwork & Collaboration