Director,Diagnostic Product Development

 

About BG Medicine

 

BG Medicine is a life sciences company focused on the discovery, development and commercialization of novel molecular diagnostics to improve patient care and reduce healthcare costs.BG Medicine discovers biomarkers and develops its diagnostic product candidates using its proprietary, versatile, and scalable technology platform, which integrates the precise measurement and analysis of thousands of proteins, metabolites, and nucleic acids derived from bodily fluids or tissues. This approach to biomarker discovery allows the company to pursue the most promising opportunities unconstrained by biology or specimen type. BG Medicine is leveraging its technology platform in multiple biomarker initiatives and collaborations with leading clinical research centers, major pharmaceutical companies, premier healthcare companies, and the US Food and Drug Administration. For additional information about BG Medicine, please visit www.bg-medicine.com.

 

 

Director, Diagnostic Product Development:

 

The Director, Diagnostic Product Development is responsible for developing BG Medicine’s in vitro diagnostics products.  He/she will play a key role in determining which biomarker opportunities are technically feasible product candidates, as well as planning, coordinating, and managing activities related to product development.  The Director, Diagnostic Product Development will be instrumental in building the product development infrastructure required to execute the company’s diagnostics business plan, and will routinely update the executive committee on progress in this regard. The successful candidate will also oversee and inform contract immunoassay development, and will build and lead an internal product development group. 

 

 

Roles and Responsibilities: Will be responsible for the following:

 Direct product development, both external and internalBuild and manage an internal diagnostics product development groupDevelop methods for internal in vitro diagnostic immunoassay product development based on biomarkersLead the development of analytical validation protocols for new IVD productsPlan, negotiate, and manage contracts for antibody development, production, and supplyConduct well-organized research in a quality controlled environment Prepare and deliver scientific presentations at relevant industry conferencesLead and coordinate drafting and submission of manuscripts for publication in peer-reviewed scientific journals

 

 

Requirements:

 Masters level or PhD in life sciences, and 6-10 years of immunoassay development experience with a leading clinical diagnostics company Specific expertise must include enzyme-linked immunosorbent assay (ELISA) technology, antibody development, screening and selection, assay formatting and optimization methodsTrack record of working with research and development partners and collaborators, as well as managing contractor relationships.Strong leadership skills and proven ability to manage team of scientists.History of making public scientific presentations to peers; excellent communication skills Some travel required.