Director, Clinical Biomarkers, Precision Medicine, CV/Met

As part of the Precision Medicine team, this Director will independently lead implementation of a biomarker strategic vision for development programs across one or more therapeutic focus areas (TFAs). In this role, they will design, develop, communicate at senior levels and operationally implement Precision Medicine strategies to support all relevant programs in early and late stage drug development for Cardiovascular and Metabolism related programs.

• enhancing our understanding of indications at a molecular level,
• conducting novel biomarker discovery,
• qualifying biomarkers to expedite early proof-of-concept studies
• optimizing label claims for later stage candidates

The role requires in-depth knowledge of implementing biomarker strategy in clinical development, broad understanding of disparate biomarker technologies, and deep experience in biomarker assay development and validation in clinical drug development. The Director will conduct in-depth literature and technology reviews for all clinical development programs within the TFA, engaging KOLs/third-party labs as needed, and directly aligning on the clinical biomarker strategy with both research scientists and medical study directors. The Director will collaborate with various research colleagues within Regeneron and partnered alliances to participate on strategic project teams, clinical sub teams, and joint project teams as needed. The Director will work closely with the clinical operations team to ensure sample collection and biomarker analyses are successfully conducted in clinical studies. The Director will ensure fit for purpose validation for all clinical biomarker assays used in all programs throughout the TFA. The Director will independently prepare and make regular high-level presentations to development team leadership and senior management both to propose clinical biomarker strategies and summarize outcomes of biomarker-driven research. The Director will contribute 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.

This job may be for you if you have the following:

• Ph.D. and/or M.D.
• 10+ years’ experience participating optimally on cross-functional teams in pharmaceutical or biotech industry
• 2-5 years' experience in clinical development strongly preferred
• Experience in cardiovascular/fibrosis and/or metabolism drug development.
• Extensive insight and experience in basic, translational or clinical research related to biomarkers, pharmacogenetics, and/or other clinical technologies.
• Ability to drive, lead, execute and deliver results for complex multi-functional projects required
• High emotional intelligence, organizational skills and effective team skills required
• Excellent communication and presentation skills required.
• Excellent track record in mentorship and development of direct reports strongly preferred
• Evidence of positive influence of senior leaders and effective team skills 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. #LI-SC1