Responsibility for the design and implementation of strategic development plans for production of nasally administered vaccines using nano-scale emulsion technology. Initial products would be for the prevention of influenza and hepatits B infection.

Key responsibilities include:

• Design the clinical & regulatory strategy and supervise the conduct of the clinical research, including protocol development, safety monitoring, statistical strategy and selection of the appropriate Contract Research Organization(s),

• Interact with regulatory authorities and outside consultants to obtain guidance regarding clinical development plans that will provide the highest likelihood of marketing approval

• Collaboration with NanoBio scientists and outside consultants on regulatory submissions for INDs, NDAs, BLAs and EMEAs

Requirements:

• M.D., Ph.D., or Pharm.D.

• At least 5 years of experience in biotechnology and/or pharmaceutical industry, including specific vaccine development experience.

• Ability to effectively apply technical principles, theories and concepts to vaccine pre-clinical study designs and drug development.

• Successful experience advancing drugs from pre-clinical development into Phase I, Phase II and Phase III trials.

• Experience contributing to Regulatory filings.

• Independent, self-motivated and able to multi-task with proficiency in Word, Excel and Powerpoint.

• Enjoys an entrepreneurial, start up environment with the flexibility and initiative to move projects forward in a small but growing biotechnology company.