Associate Director, Precision Medicine (Immunology & Inflammation)

Location
Tarrytown, NY, United States
Posted
Mar 25, 2019
Ref
15591BR
Required Education
Doctorate/PHD/MD
Position Type
Full time
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.

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 teams to promote early adoption of biomarker strategy to guide clinical translation, collaborates with Clinical Sciences colleagues to develop the clinical experimental sciences (CES) studies for generating clinically testable, mechanistic hypotheses for each molecule. Precision Medicine leads the biomarker strategy and execution to achieve proof of mechanism/concept in early clinical trials. The team also implements Precision Medicine strategies to support late-stage clinical programs and companion diagnostics. Our team includes Precision Medicine Strategy Leads, Precision Medicine Operations specialists, as well as quantitative analytical and companion diagnostics scientists.

The Associate Director works closely with Director, Precision Medicine and other key clinical and research personnel to take ownership of and execute the Precision Medicine strategy for programs in Regeneron's Immunology & Inflammation pipeline. Leads I&I biomarker discovery efforts, including the internal platform development, academic and commercial collaborative programs. Technologies will be applied strategically to goals of expediting proof-of-concept for new drug candidates and combinations, assessment of PK/PD relationships, optimization of label claims, and enabling precision medicine principles to be applied, as appropriate, in full development. Collaborates with the development team leads, preclinical research, technology center colleagues, clinical operations, partners from allied companies, and senior management.

Job Duties:

• Lead Precision Medicine strategy development and execution to support the clinical development portfolio, including the biomarker driven clinical study design, implementation of novel technologies and incorporation of biomarker endpoints.

• Lead biomarkers development and implementation through the application of genomic (RNA and DNA sequencing), protein and cell/tissue analysis, and clinical device technologies, as needed.

• Champion early-adoption of biomarkers strategy for pipeline pre-clinical programs and generate proposals for clinical experimental sciences studies, in close collaboration with Clinical Sciences, I&I Research, and Regeneron Genetics Center (RGC) colleagues.

• Represent Precision Medicine on cross-functional strategic project teams and global clinical sub-teams across the development portfolio.

• Provide cross-functional team leadership of internal clinical biomarker discovery platform development (laboratory assays, computational biology methods), in collaboration with research, molecular profiling and genomics center teams.

• Present the clinical translational project plans, clinical trial protocols, biomarkers data and interpretation of results to internal stakeholders (including senior management), regulatory agencies and global opinion leaders, as needed.

• Evaluate emerging technologies and vendors to consider for future programs and to interpret data across programs.

• Willingness to work across multiple therapy areas such as Immunology & Inflammation, Muscle & Metabolism, and Immuno-oncology.
Requirements:

Education:

• Ph.D., M.D., or equivalent degree with post-doctoral experience
Experience and required skills:

• Minimum 5-10 years pharmaceutical industry experience which should include research and/or translational clinical development experience is preferred.

• Experience in translational biomarker data analysis and interpretation in collaboration with computational biology scientists desired.

• Excellent written and verbal communication skills, as well as experience in cross-functional team presentation of complex scientific data essential.

• Ability to work in a fast-paced, collaborative, and matrixed environment is a must.

• Has authored industry documents and/or has published in medical/scientific peer-reviewed journals.

SKC, #LI-SC1, clinical experimental sciences, CES, Immunology, Allergy, Respiratory, Asthma

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.