Director, Clinical Development at , Rockville, MD

POSITION SUMMARY:

The Director, Clinical Development will lead all aspects of a specific clinical product’s development, including oversight of the design and execution of clinical studies to evaluate and test tuberculosis vaccines intended to support product licensure.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Creates and maintains the product profile(s) and product development plan(s) for his/her product(s).
• Develops a sound regulatory approach to enable the review and approval of Aeras’ human studies and the review and approval of marketing applications and biological license applications.(in conjunction with Regulatory Affairs)
• Oversees the execution of vaccine clinical trials of all phases, including the following specific activities:

1. Study design
2. Medical monitoring
3. Coordination of plans for statistical analyses, blinding, and unblinding of group and individual data. (in conjunction with Biostatistics and Data Management)
4. Review of data listings and tabular summaries
5. Data analyses and interpretation
6. Generation, review and approval of interim and final study reports. (in conjunction with Medical Writing)

• Serves as primary contact with product-specific external partners and collaborators, coordinating and attending product steering committee meetings.
• Ensures the timely preparation and submission of clinical investigator brochures and updates, periodic investigational product reports, final study reports, and integrated summaries of safety, immunogenicity, and efficacy. (in conjunction with Clinical Operations, Medical Writing, and Regulatory Affairs)
• Provides guidance to cross-functional project team members regarding the critical issues in each protocol for product development.  May lead and/or attend protocol team meetings as required.
• Provides input to Pre-Clinical and Manufacturing (or external partners/collaborators)on non-clinical studies and assays of clinical specimens.
• Supervises preparation of product- and protocol-specific presentations to, DSMBs, internal and external review committees, partners and collaborators as appropriate.

QUALIFICATIONS AND REQUIREMENTS:

• M.D., Ph.D. degree or equivalent, or more than 10 years related experience and/or training, or equivalent combination of education and experience
• Extensive background in clinical research and research management, preferably in vaccines or tuberculosis research and/or tuberculosis control programs