Associate Director, Biomarker Assay Validation, Precision Medicine

As an Associate Director in Precision Medicine Operations, you will establish a process for development, validation and implementation of clinical biomarker assays, and proper control of pre-analytical variables. This effort will support both early and late stage clinical studies in all disease areas. We will bring to bear 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.

Our goal is to enhance understanding of indications to enable personalized medicine principles to be applied, in full development.
Responsibilities:Develop and implement a strategy and approach to ensure biomarker and CDx assays for clinical endpoints and patient stratification/selection are validated for the Context of Use and meet regulatory requirements

• Provide leadership for internal efforts and influence external vendors to standardize and harmonize processes for biomarker sample matrix selection, specimen collection, processing and storage.
• Collaborate with Global Clinical Operations to build positive relationship with Central and Specialty labs and provide monitoring and oversight for laboratory execution at the external vendors.
• Provide guidance for building resource and tools to improve efficiency for biomarker assay development and validation within precision medicine, Regeneron external laboratory vendors/partners, diagnostic vendors/partners as well as cross-functionally across Regeneron.
• Collaborate with internal Regeneron laboratories (e.g. Discovery Research, Molecular Profiling, Regeneron Genetics Center, DNA core, BioAnalysis, etc.) to apply and validate research assays and generate standardized assay method documentsEnsure timely delivery of clinical assays consistent with program team and senior management expectations that maximizes the potential impact of Precision Medicine results on Global Development programs.
• Partner with Clinical Trial Management, Vendor Management, Outsourcing and Procurement and Precision Medicine to ensure the vendors are executing clinical trials on time, and with the highest quality, through cross-company and cross-partnership collaboration.

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.

Experience and Required Skills:
To be considered for this position, you will need a Ph.D. and/or MD along with 10 years' experience on cross-disciplinary teams in the pharmaceutical or biotech industry, including at least 5 years in clinical assay development, validation and implementation. In depth knowledge of regulatory requirement and CLIA/CAP guidelines for biomarker method validation, and best practices. Extensive experience with contract laboratory outsourcing and effective relationship management and governance. Experience in basic, translational or clinical research related to biomarkers, pharmacogenetics, imaging, and/or other clinical technologies. Understanding of technical, regulatory, clinical, and strategic aspects of these areas required.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

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.

Requirements:
• Ph.D. and/or M.D.
• 10 years' experience participating effectively on cross-disciplinary teams in pharmaceutical or biotech industry, including at least 5 years in clinical assay development, validation and implementation, with a track record of high impact in drug development.
• Good 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 effective 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.
• Excellent track record in mentorship and development of direct reports, as well as evidence of positive influence of senior leaders and effective team skills.
• Ability to drive, manage, execute and deliver results for complex multi-functional projects required
• High emotional intelligence required
• Excellent communication and presentation skills required.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

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