Director, Project Management

II.          POSITION SUMMARY

 

The Director, Project Management, is responsible for coordinating and managing cross-functional NDA-related activities associated with the successful and timely development of the company’s lead drug candidate for Celiac Disease.  The Director, Project Management is accountable for providing strategic and operational leadership in the development and management of key activities in the CMC, non-clinical, clinical and regulatory functions, and is responsible for developing project schedules and timelines, and coordinating budgets and resources. The Director, Project Management, will also serve as assistant alliance manager for the Company’s strategic development partnership, including coordinating joint development objectives and timelines in support of worldwide regulatory approval. 



EDUCATION, EXPERIENCE AND SKILLS

 

Ø      BS degree in life sciences; MS, PhD or MBA degree highly preferred; Project Management Professional certification a plus.

Ø      Minimum of 7-10 years previous experience in drug development project management in pharmaceutical industry, biotechnology or contract research organizations.

Ø      Experience from IND through NDA and launch required.

Ø      Skilled in using computer-based tools for project planning and tracking, report writing, data analysis, presentation, budget analyses, and communication

Ø      Experience in handling aggressive timelines in a development stage environment