Head of Clinical Biomarker Integration

Organization: 
Sanofi
Job Location: 
Cambridge, MA
Job Description: 

Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. At Sanofi US, we are committed to the growth of our people, connected in purpose by career, life and health. Headquartered in Bridgewater, NJ, Sanofi US is part of a leading global healthcare company that is dedicated to improving health and driving back disease by making innovative medicines accessible to people around the world. Our extensive research and development efforts encompass a wide range of therapeutic areas that are in line with public health issues, trends and the most pressing health needs.

Job Title: Head of Clinical Biomarker Integration

Development of first-in-class/best-in-class targeted oncology drugs requires integration of translational objectives into clinical development, including assessment of mechanism of action, early signs of clinical efficacy, and discovery/validation of the appropriate patient populations in which to focus drug development. The head of Clinical Biomarker Integration will lead a team of clinically-oriented scientists to ensure successful design, planning and execution of translational medicine objectives in clinical development. The role will be accountable for the following aspects of biomarker discovery and development: - Experimental design for translational and biomarker objectives in clinical protocols, including molecular and imaging biomarker hypothesis testing and discovery of novel biomarkers - assessment of biomarker assays as analytically validated and fit for the intended purpose - Execution of translational objectives in clinical protocols including specimen or image acquisition, handling, processing, analysis and dissemination of results - Contribution of clinical and imaging scientists to program-level biomarker strategy - Translational and Experimental Medicine contribution to development of companion in vitro diagnostics - Contribution to overall business unit biomarker/translational medicine strategy and biomarker platform development - Management and mentorship of clinical scientists and imaging scientists to ensure successful design and execution of translational medicine objectives in clinical trials -Primary accountability for ensuring molecular and imaging biomarkers supporting primary or secondary objectives in clinical protocols are analytically validated and fit-for-purpose, including interaction with biomarker vendors and academic collaborators -Management of Cambridge molecular pathology laboratory to support development of molecular pathology assays, oversight of outsourced molecular pathology assays, and analysis of clinical specimens from select clinical trials -Primary accountability for Translational and Experimental Medicine contribution to in vitro diagnostic development plans and regulatory documents (e.g. IDE, PMA) -contribution to biomarker/translational medicine strategy and platform building for the business unit, including assessment of external biomarker/translational science opportunities -Representation of sanofi Translational and Experimental Medicine at external meetings with industry and academic collaborators; interaction with professional societies and consortia (AACR, ASCO, etc)

Requirements: 

Basic QualificationsRequired: PhD or MD/PhD with 8+ years of experience in clinical biomarker discovery/development or translational science

Preferred: Board certification in anatomic pathology, clinical pathology or oncology 4+ years in the pharmaceutical, diagnostic, or medical device industries In vitro diagnostic development experience Skills: - Background in molecular biology, pathology, genomics or imaging science - Experience in the design of clinical biomarker experiments: identification of most appropriate molecular or imaging biomarker platforms; identification of appropriate clinical endpoints; identification of appropriate specimen or image collection protocols; understanding of statistical principles to ensure experiments are appropriate to detect clinically significant results - Track record of successful execution of clinical biomarker experiments demonstrated by abstracts, peer-reviewed publications and/or patents - Strong written and verbal communication skills - Ability to work in a team environment.

Contact Information: 

Please apply via our website. www.sanofi.us Req. ID 19732.

About Our Organization: 

Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme.

Sanofi US

At Sanofi US, we are committed to the growth of our people, connected in purpose by career, life and health. Headquartered in Bridgewater, NJ, Sanofi US is part of a leading global healthcare company that is dedicated to improving health and driving back disease by making innovative medicines accessible to people around the world.

Our extensive research and development efforts encompass a wide range of therapeutic areas that are in line with public health issues, trends and the most pressing health needs.

Sanofi US, along with the other US affiliates, Genzyme, Sanofi Pasteur, Merial and Chattem, employs more than 17,000 people across the country.

Commitment is our Strength. Ready to grow together.

Sanofi US endeavors to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-800-207-8049 Option 7, then Option 3.

Sanofi US is an equal opportunity employer that embraces diversity to foster positive, innovative thinking that will benefit people worldwide. Sanofi US is also committed to employing qualified individuals with disabilities and, where warranted, will provide reasonable accommodation to applicants, as well as its employees.