Director, Biomarker Assay Validation, Precision Medicine

Location
Tarrytown, NY, United States
Posted
Jan 07, 2021
Ref
23008BR
Required Education
Doctorate/PHD/MD
Position Type
Full time
Precision Medicine is looking to build a team passionate about Biomarker Assay Context of Use and Laboratory Management/Oversight.

As a Director, Precision Medicine this position will provide leadership for establishing a process for development, validation and implementation of our clinical biomarker assays, and proper control of pre-analytical variables. This effort will support both early and late stage clinical studies, clinical experimental science (CES) and CDx studies in all disease areas. We use clinical technologies on all technical platforms including and not limited to: immunoassay, LCMS, IHC, flow cytometry, pharmacogenetics, as well as clinical and other physiological testing devices.

A typical day may include
  • Developing and implementing our new department-level strategy and approach that will ensure that biomarker and CDx assays for clinical endpoints and patient stratification/selection are
  • Leading our internal efforts and influence external vendors to standardize and harmonize processes for biomarker sample matrix selection, specimen collection, processing and storage.
  • Collaborating with Global Clinical Operations to build positive relationship with Central and Specialty labs and provide monitoring and oversight for laboratory execution at vendors.
  • Establishing data and harmonized approaches for Sample Lab Manual development and implementation and for investigator site training
  • Provide guidance for building resource and tools to improve efficiency within precision medicine, Regeneron external laboratory vendors/partners, diagnostic vendors/partners as well as cross-functionally across Regeneron.


This may be for you if:
  • You can drive manage execute and deliver results for complex multi-functional projects
  • You can build process and influence positive change among internal and external partners.
  • You enjoy mentoring and development of scientists
  • You have a track record of high impact drug-development.

To be considered for this position, you should have and Phd and/or MD with over 10 years' experience participating effectively on cross-disciplinary teams in pharmaceutical or biotech industry, including at least 7 years in clinical assay development, validation and implementation. It is expected you would have an understanding of the unique challenge for biomarker assay development, validation and implementation. In depth knowledge of regulatory requirement and CLIA/CAP guidelines for biomarker method validation, and industry best practice.
  • Extensive experience with contract laboratory outsourcing and relationship management and governance.
  • Extensive insight and experience in basic, translational or clinical research related to biomarkers, pharmacogenetics, imaging, and/or other clinical technologies. Strong understanding of technical, regulatory, clinical, and strategic aspects of these areas required.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.