Sr. Director Precision Medicine-Oncology

Location
Tarrytown, NY, United States
Posted
Aug 05, 2019
Ref
16827BR
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.

As part of the Precision Medicine team and reporting to Head of Precision Medicine, this Sr. Director will lead implementation of a strategic vision that will position Regeneron as a global Precision Medicine leader in Oncology. In this role, they will develop and operationally implement Precision Medicine strategies to support both early and late stage drug development in Oncology. 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 oncology 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.

Job Duties:

• In partnership with the Head of Precision Medicine, lead implementation of strategic vision that will broadly enable advances in target identification, indication selection, early indication of biological activity and patient stratification/selection to position Regeneron as a global leader in Oncology

• Provide strategic leadership, influence cross-functional teams and the broader organization to prioritize and execute a compelling Precision Medicine vision in Oncology that will broadly enable advances in target identification, indication selection, early indication of biological activity and patient stratification/selection

• Collaborate with Oncology 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 in Oncology.

• Represent Regeneron and work with colleagues from allied companies to develop and implement Precision Medicine strategies for oncology in partnered programs.

• Collaborate with clinical operations teams to implement exploratory sample collection and analyses in clinical studies related to oncology.

• Manage internal and external research collaborations in areas of clinical technologies and oncology 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 Oncology 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.

• Mentor independently of line management organization in the art and science of Oncology biomarkers and drug development.

• Supervise other Ph.D. scientists supporting Oncology projects.

Requirements:

Education

• Ph.D. and/or M.D.

Experience

• 10-15 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 Oncology drug development.

• 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.

SKC, #LI-SC1, biomarker strategy, clinical development, oncology, immuno-oncology

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.