Director, Precision Medicine (CV/Met, Neuroscience, Infect Disease) -
Employment Type: Full-Time
Industry: Healthcare - Allied Health
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Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
As part of the Precision Medicine team and reporting to Head of Precision Medicine, this Director will lead implementation of a biomarker strategic vision in development programs. In this role, they will develop and operationally implement Precision Medicine strategies to support both early and late stage drug development. Clinical technologies applied include: biomarkers, pharmacogenetics, as well as clinical and other physiological testing devices. Such technologies will be applied to goals of: enhancing our understanding of indications at a cellular and molecular level, biomarker discovery and qualifying new biomarkers and approaches for expediting proof-of-concept for new drug candidates, optimization of label claims for later stage candidates, and enabeling 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, 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, (e.g. Discovery Research, Molecular Profiling, DNA Core, Regeneron Genetics Center), development team leadership, clinical operations, colleagues from allied companies, and senior management.
In partnership with the Head of Precision Medicine, lead implementation of program-level strategic vision that will broadly enable advances in target identification, indication selection, early indication of biological activity and patient stratification/selection
Provide strategic leadership and influence cross-functional teams to prioritize and execute a compelling Precision Medicine vision that will broadly enable advances in target identification, indication selection, early indication of biological activity and patient stratification/selection
Collaborate with Discovery Research and product development teams to facilitate appropriate incorporation of Precision Medicine strategies for molecules in discovery phases (leading to candidate molecule selection) or development.
Represent Regeneron and work with colleagues from allied companies to develop and implement Precision Medicine strategies for partnered programs.
Collaborate with clinical operations teams to implement exploratory sample collection and analyses in clinical studies.
Manage internal and external research collaborations in areas of clinical technologies and translational research.
Ensure complex clinical assays are fit-for-purpose (whether developed and validated internally or externally)
Collaborate with internal Regeneron laboratories (e.g. Discovery Research, Molecular Profiling, Regeneron Genetics Center, DNA core, BioAnalysis, etc.) to develop plan for validation and application of research assays.
Ensure timely delivery of results consistent with program team and senior management expectations in a way that maximizes the potential impact of Precision Medicine deliverables on Global Development programs.
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.
Supervise other Ph.D. scientists supporting Global Development Programs.
10 years' experience participating effectively on cross-disciplinary teams in pharmaceutical or biotech industry, including at least 5 years in clinical development, with a track record of high impact in drug development.
Experience in cardiovascular/metabolic, neuroscience, skeletal or infectious disease development preferred.
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.
Ph.D. and/or M.D.
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.
Associated topics: drug discovery, food, immunoassay, injury, medical, metabolism, microbiological, patient, pharmacy, therapeutic
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