Project Leader Pharmaceutical Development

(Job Id W329438)
Posted on 4/28/2010
Location:

Research Triangle Park, NC


Job Type:

Full Time


Salary: $95000.00 to $120000.00/year
Degree: Doctor of Philosophy
Job Description
Position Details
Position:Manager Pharmaceutical Contract Drug Development

Description: The manager will be responsible for working within a multi-disciplinary team of scientists to provide project management support for drug development programs. The successful candidate will closely interact within an interdisciplinary team of scientists to coordinate activities for the development, characterization and manufacturing of drug substance and drug product clinical supply material for new chemical entities.
RESPONSIBILITIES;

Participate in the identification and qualification of development organizations and contract manufacturing vendors.

Facilitate and coordinate the development of strategic plans for multiple drug development projects from preIND through NDA filing.

Track product development progress against key deliverables and provide effective communication on status.


Provide administrative and technical leadership (MENTOR) to junior team members.
Requirements: EDUCATION AND EXPERIENCE REQUIREMENTS:
Minimum Requirements:

Position will require a PhD in a scientific discipline and a minimum of eight (8) years of product development experience in the pharmaceutical or biotech industry.

Prior experience with appropriate GMP and regulatory requirements for INDA and NDA filings required

Coordination of teams, project management, and management of vendors experience
Ability to communicate clearly and concisely in both oral and written communications

Strong analytical skills with ability to identify alternative solutions and implement recommendations. Demonstrated ability to recognize anomalous and inconsistent results and interpret experimental outcomes