DIRECTOR/SENIOR DIRECTOR, CLINICAL & REGULATORY AFFAIRS

Biotechnology company, located in Ann Arbor, uses a novel nanotechnology to develop topical and mucosal agents for the treatment and prevention of infectious diseases.  We are seeking a highly motivated, experienced person with regulatory and/or pharmaceutical experience to join our dedicated team. 

 

RESPONSIBILITIES

Individual will be responsible for the design and implementation of strategic development plans for non-scale emulsions as topical and/or mucosal pharmaceutical products for the treatment and prevention of viral infections, including:Design of clinical development plans & protocols, including safety monitoring, statistical strategy and selection of the appropriate Contract Research Organization(s)Interaction with regulatory authorities to seek guidance regarding clinical development plans that will provide the highest likelihood of marketing approvalCollaboration with the Company's scientists and outside consultants on regulatory submissions for INDs, NDAs, BLAs and EMEAs

 

REQUIREMENTSM.D., PhD., or Pharm.D.Minimum of 5 years of experience in biotechnology and/or pharmaceutical industry;anti-infective, anti-viral, dermatology or immunology experience preferredIndependent, self-motivated and able to multi-task Proficiency in Word, Excel and PowerPointMust be willing to work in an entrepreneurial, start-up environment with the flexibility and initiative to move projects forward in a small but growing biotechnology company

 

Medical, 401(K), FSA, offered.  Please include salary requirements with response.