Project Manager - Predictive Safety Testing Consortium

POSITION ANNOUNCEMENT

The Predictive Safety Testing Consortium (PSTC) is a unique public-private partnership, led by the non-profit Critical Path Institute (C-Path), that brings together pharmaceutical companies to share and validate each other's safety testing methods under advisement of the U.S. Food and Drug Administration (FDA) and its European counterpart, the European Medicines Agency (EMA). The 16 corporate members of the consortium share internally developed pre-clinical safety biomarkers in five workgroups: carcinogenicity, kidney, liver, muscle, and vascular injury.

 

POSITION DESCRIPTION

Title: Project Manager
Location: Tucson, Arizona

The Project Manager will work closely with the Predictive Safety Testing Consortium Director and Assistant Director to facilitate and support the consortium's multiple global, virtual workgroups in their efforts in identifying and qualifying pre-clinical and clinical safety biomarkers to improve drug development. PSTC has several workgroups comprised of leading scientists from industry, academia, and governmental regulatory agencies working on biomarkers to detect and monitor specific organ toxicities. Data from existing and prospectively conducted studies and clinical trials are pooled and analyzed to enable the comparison of novel biomarker performance to existing accepted endpoints.

 

POSITION QUALIFICATIONS

This position requires strong oral and written communication skills, including fluency in technical scientific language and writing, effective leadership, good problem-solving and organizational skills, creativity, and flexibility. The position requires self-motivation and the ability to work in a fast-paced environment with top scientists.

 

Education and Training

  • A master's degree in toxicology, molecular biology, biochemistry, or similar field with project management experience.
  • Experience in the pharmaceutical industry and the drug development process.
  • Working knowledge of the design and conduct of toxicology safety assessment studies, histopathology, assay development and validation, and biostatistical analysis.
  • Training, experience, or certification as a Project Manager is desirable.
  • Proficient use of Microsoft Excel, Word, PowerPoint, Outlook, and Project required.

Leadership

  • Help lead the team to successful completion of goals.
  • Facilitate obtaining consensus among the participants.
  • Identify opportunities for improvement and make constructive suggestions for change.
  • Adapt to shifting priorities, demands, and timelines.
  • Remain on the forefront of emerging industry practices.

Teamwork

  • Acknowledge and appreciate each team member's contributions.
  • Motivate team to work together in the most efficient manner.
  • Keep track of best practices and lessons learned and share those with the team.
  • Mitigate team conflict and communication problems.

Consortium Member Relationship

  • Develop relationships with external consortium members and participants from industry, FDA and EMA, and academia.
  • Manage working group and consortium expectations.

 

POSITION RESPONSIBILITIES

Project Management

  • Help create and document project scope and deliverables.
  • Create and execute project work plans and revise as appropriate to meet changing needs and requirements.
  • Oversee and track project schedules, and take corrective action when needed.
  • Help define and document roles and responsibilities.
  • Manage day-to-day operational aspects of the project.
  • Ensure project documents are complete, current, and stored appropriately.
  • Minimize exposure and risk on project.

Communications

  • Help develop and foster good working relations with individual scientists, external partners - and other organizations working on the projects.
  • Facilitate consortium meetings effectively, follow up on action items, and record minutes.
  • Keep the membership rolls and member contact information up to date.
  • Write concise and accurate reports, proposals, and other supporting materials.
  • Prepare, facilitate, and/or give reviews with upper management and other stakeholders.
  • Hold regular status meetings with project team.
  • As appropriate, aid in the preparation of documents for submission to the FDA and EMA for review and qualification. Monitor progress of review by FDA and EMA.
  • Assure project legal documents are completed, signed, and stored appropriately.
  • Travel on occasion for out-of-town meetings.

Organizational Development

  • Suggest areas for improvement in internal processes along with possible solutions.
  • Lead internal teams/task forces as assigned.
  • Share knowledge with others.
  • Seek and participate in personal development opportunities.

 

If interested in applying for this position, please send cover letter, resume and names of three references to:

Human Resources
Critical Path Institute
1730 East River Road, Suite 200
Tucson, AZ 85718

Or you can email C-Path here.