Associate Director, Biomarker Assay Validation, Precision Medicine

Local Jobs Regeneron in Business Development
  • United States, Tarrytown, NY View on Map
  • Post Date : July 9, 2020
  • Apply Before : August 8, 2020
  • Share:

Job Description

Position Summary

Regeneron is advancing its pipeline portfolio using a data-driven human translational approach. As part of this initiative, the Precision Medicine team in Early Clinical Development & Experimental Sciences (ECD&ES) is integrated with Discovery Research and Clinical Development teams to promote early adoption of biomarker strategy to guide clinical translation. The team collaborates with Clinical Sciences colleagues to develop the clinical experimental sciences (CES) studies for generating clinically testable, mechanistic hypotheses for each molecule, including developing scientific rationale for initial and new indications for PoC. Precision Medicine leads the biomarker strategy and execution to achieve proof of mechanism/concept in early clinical trials. .

As part of the Precision Medicine Operations team (PMops) and reporting to Head of PMops, this Assoc. Dir. will provide leadership for establishing a process for development, validation and implementation of clinical biomarker assays, and proper control of preanalytical variables. This effort will support both early and late stage clinical studies, clinical experimental science (CES) and CDx studies in all disease areas, and leverage 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. This is aligned with the overall goal of the Precision Medicine Group to enhance understanding of indications at a cellular and molecular level, to support biomarker discovery and qualifying new biomarkers and approaches for expediting proof-of-concept for new drug candidates, to optimize label claims for later stage candidates and to enable personalized medicine principles to be applied, as appropriate, in full development. The role requires in-depth knowledge of clinical assay development and validation approaches and applications in drug development, good understanding of regulatory requirement and industry best practice, detailed literature and technology reviews, consultations with experts in multiple therapeutic areas, understanding of logistical and regulatory factors pertaining to clinical technologies, and close collaborations with research colleagues.

Responsibilities:
Precision Medicine is looking to fill a strategic role to to build a team focused on Biomarker Assay Context of Use and Laboratory Management/Oversight:

  • In partnership with the Head of Precision Medicine Laboratory Operations, develop and implement a new department-level strategy and approach that will ensure that biomarker and CDx assays for clinical endpoints and patient stratification/selection are validated for the Context of Use and meet regulatory requirements
    • Oversight across all technical platforms, e.g., immunoassay, LCMS, IHC, flow cytometry, pharmacogenetics
    • Supporting clinical studies (FIH to post-marketing), clinical experimental science (CES) and patient selection/stratification studies across all disease areas
  • Provide leadership for internal efforts and influence external vendors to standardize and harmonize processes for biomarker sample matrix selection, specimen collection, processing and storage. This effort should be guided based on industry best practice to ensure that the preanalytical variables are well understood and properly controlled to ensure quality data to guide decisions and clinical endpoints.
  • Collaborate with Global Clinical Operations to build strong partnership with Central and Specialty labs and provide monitoring and oversight for laboratory execution at the external vendors. Conduct regular audit/technical visits to ensure that assays are properly validated and implemented for clinical sample analysis, the analytical assay performance and operational rigor meet our clinical study needs and ensure scientific excellence and execution.
  • Establish data-driven 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 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 documents
  • Ensure timely delivery of clinical assays consistent with program team and senior management expectations that maximizes the potential impact of Precision Medicine deliverables on Global Development programs.
  • Support internal and external research collaborations in areas of clinical technologies and translational research
  • Contribute to and ensure the quality of Precision Medicine technical reports, study memos and clinical study reports, data reviews and interpretations, scientific publications and recommendations to development teams and management.
  • Contribute to and review documents pertaining to regulatory interactions and filings related to Precision Medicine, including product labeling and participates as appropriate in internal and external meetings.
  • Work in close collaboration 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 role is also responsible to establish strategic relationships with external laboratory partners and to gain a solid understanding of business processes to guide direct reports to facilitate study teams to effectively manage potential escalations and enable proactive quality business processes to ensure quality clinical trial data delivery and execution.
  • Provide support as point of contact to review study documentation to ensure external laboratory processes are considered to minimize gaps and mis-alignment between study team needs and external laboratory processes.
  • Supervise other Ph.D. scientists supporting Global Development Programs.

Experience and Required Skills:
Requirements:

  • Education: 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.
  • 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 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

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.

An important note about privacy: Regeneron is committed to your privacy and will not ask for sensitive personal information such as social security number, date of birth or bank account details via email or social media. We do not interview candidates on Google Hangouts. Any questions about job listings can be directed to [email protected] We also do not hire for “at-home data entry” positions.

Other jobs you may like

Go to Top