Excecutive Director Clinical Research

Please send a resume in a word attachment to Judie Sampson at sms_resume@earthlink.net Thank you!!!

Our Client Company is a vaccine development company focused on the research, development and commercialization of vaccines utilizing its proprietary virus-like particle technology for large and growing markets.

We are seeking a Clinical Immunologist with vaccine development experience to join our Vaccine Development department in Maryland. Qualified individuals will be expected to play a leadership role in the development of our influenza VLP vaccine and candidates and play a key role in bridging preclinical and clinical development. The position will primarily be responsible for creating and leading the product development strategy integrating all functional line activities to meet the target product profile and achieve product licensure.

Responsibilities include but are not limited to:

- Lead development of VLP vaccine candidates

through clinical development to licensure

- Provide critical input on the design of

preclinical studies supporting clinical

strategy

- Provide critical input on the clinical

development strategy including second

generation vaccines

- Design or oversee the design of key clinical

immunologic assays as needed to investigate

humoral, cell mediated, and/or mucosal immune

responses.

- Manage laboratories for those assays that are

developed externally or outsourced.

- Lead or assist with leadership of second

generation vaccines (i.e., alternate route of

administration or addition of adjuvant)

- Take a lead role in contributing to

immunologic strategy for vaccines to meet

target product profiles

- Manage key external technology partnerships

- Represent the company and present progress on

development programs at key conferences and

meetings

Minimum requirements:

- Ph.D and/or MD degree in immunology or

equivalent with relevant experience

- Minimum of 5 years experience in

pharmaceutical, biologics, biotech R&D

environment.

- Technical knowledge and competency in field of

vaccine immunology; focus on cell mediated

immunity desirable

- Previous experience in design and conduct of

clinical vaccine studies

- Experience in development and management of

clinical immunologic assays

- Knowledge of FDA requirements for vaccine

development

- Knowledge of FDA requirements for vaccine CMC

development

- Self-starter who will move forward with key

initiatives without being prompted

- Evidence of effective leadership skills

- Good verbal and written communication skills

- Ability to work cross-functionally

- Evidence of successful alliance management

skills

This position may require periodic weekend/evening work.