Launching Sterile Water for Injection, USP - First in the USA in plastic pre-filled syringe

Sr. Director of Program Management

  • Reference ID: PM001
  • Type: Full Time

Location:  Glendale Heights, IL                                                                                             

Reports to:  Chief Strategy Officer        

Department:  Program Management

 Job Number:  PM001                                                                 

 Level/FLSA:  Exempt

Position Summary: The Sr. Director of Program Management is responsible for overall coordination and planning for programs of large scope, budget and strategic importance. This typically includes research and development programs through FDA approval and launch of product. The incumbent will work with the scientific program leadership to oversee, organize and shape research and development programs to ensure that all goals and milestones are met per agreed upon program specifications. Effective coordination of numerous disciplines is required for successful execution. In this role, the Sr. Director of Program Management will work with the team to develop the program plan, execution of the program plan to timelines and budget, and ensure appropriate and timely decision-making and progress. The Sr. Director of Program Management sets the agenda and chairs recurring program team meetings, and ensures effective cross functional communications are achieved with all team members. Important duties also include communicating progress and highlighting risks, timeline delays and other issues to the Executive Leadership Team. Previous drug development and global program team experience is required.

Key Responsibilities include:

  • Leads the design and execution of cross-functional program plans for drug development with a variety of program management tools
  • Maintains frequent communication with the cross-functional program team members and key internal stakeholders so that all parties are aware of current program status, issues, contingencies, and milestones
  • Prepares summary information on program progress, timeline updates and risk assessment for periodic presentations to Medefil Leadership
  • With team members and in accordance with corporate objectives, facilitates the setting of program strategy and objectives, key milestones and scope
  • Leads team meetings and ensures that clear actions and decisions are documented, communicated and committed to, enabling timeline achievement
  • Builds strong working relationships across departments, with key stakeholders, and Senior Management to ensure transparency and to facilitate communication
  • Build and mentor program management team as the company grows

Minimum Qualifications

  • Minimum of 15 years Project management experience with injectable drug development
  • Must be an innovative, driven, highly organized self-starter with the ability to handle multiple activities and comfortable interacting with all levels of management within the company
  • Demonstrated in depth knowledge of the pharmaceutical industry and the drug development and approval process required
  • Extensive intermediate to advanced computer skills (Power Point, Excel, Word, MS Project, SharePoint)
  • Expert level knowledge of project management methodology, including advanced skills in developing Gantt Charts and asset timelines
  • Ability to influence colleagues in a matrixed organizational structure
  • Skilled in risk management and contingency planning
  • Proven injectable drug development program management experience from pre-concept, formulation development, Analytical, regulatory, manufacturing and FDA approval
  • Extensive experience with research and development budgeting for novel therapeutics and ability to review and explain variances from approved budgets
  • Strong communication skills, both verbal and written
  • Excellent interpersonal skills including people management, time management, organizational, and prioritization skills
  • Proven ability in negotiating/influencing and collaboration skills.
  • Willing and able to learn new skills to meet changing needs of the organization.
  • Master’s degree in biology, chemistry or other related scientific area

Preferred Qualifications

  • MS/PhD degree in biology, chemistry or other related scientific area, with at least 10 years of post-graduate experience in Pharm/Biotech industry, with a minimum of 15 years of formal Pharmaceutical/Drug Development program management experience
  • The desire to deliver innovative and clinically meaningful therapies that improve the lives of patients with genetic disorders
  • PMP designation or MBA considered an asset

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