Clinical Scientist, Early Clinical Development & Experimental Sciences

Location
Tarrytown, New York, US
Posted
Jun 08, 2018
Ref
12993BR
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Summary

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:
Qualified physician or scientist with training in the pharmaceutical/biotechnology sector, or academic or clinical setting. Works closely with supervisor and other members of the cross-functional team, contributes to early development and clinical experimentation for projects for discovery phase through Proof of Concept (POC).

Regeneron, has made a major effort in discovery of immunotherapeutics across all disease areas. Results of this research include Aflibercept for age-related macular degeneration, Alirocumab for hyperlipidemia, Dupliumab for atopic dermatitis, Sarilumab for rheumatoid arthritis and Cemiplimab, an anti-PD-1 antibody now in registrational cancer trials.

We are committed to advancing our immunotherapeutics using a data-driven approach. Tenable this, ECD&ES are a) conducting clinical experimental studies aimed at state-of-the-art disease tissue profiling analytics, conducted in-house, including DNAseq, RNAseq, in-situ RNA hybridization; b) developing novel antibody-based clinical imaging platforms; c) embedding clinical translationalists into Discovery research teams, to generate clinically testable mechanistic hypotheses for each therapeutic, and design plans to achieve proof of mechanism early in clinical testing, d) designing and executing on informative early development phases, from first-in-human through POC. Our team comprises a small group of clinical scientists. This clinical group reports to the Vice President of Therapeutic Areas within ECD&ES, who reports through the Head of ECD&ES to the Head of Global Clinical Development.

Responsibilities:
Supports the cross-functional study team on the following activities, including but not limited to:
  • Provides background literature searches and contributes to the design of the early clinical strategy in terms of indication selection, study rationale, scientific/clinical endpoints
  • Provides background literature searches and contributes to the design of POC-enabling human studies, First-In-Human (FIH) studies, clinical experimental studies as per clinical strategy
  • Contributes to he writing of clinical study concepts (CSCs) and clinical study protocols (CSPs) and amendments.
    • Identifies key internal and external collaborators/advisors, organizes and conducts consultations with global subject matter experts
  • Represents the clinical ECD&ES function on clinical study teams, contributing medical/scientific knowledge to timely and compliant clinical trial execution and quality of deliverables
    • Work alongside Clinical Trial Manager to provide day-to-day clinical input to the study team
    • Train and support study team and CRO personnel
    • Contribute to key documents: briefing books, IND/IMPD submissions, consent forms, ethics submissions, medical monitoring plans, statistical analysis plans, clinical study reports, abstracts and manuscripts for publication
    • Accountable to the Clinical Lead for the project for a specific trial: first-line medical monitoring, raising and responding to investigator queries, writing safety narratives
    • Maintains and develops relationship with key study investigators, organizes steering committees and data safety monitoring boards as required
    • Identifies program, trial or data risks, creates and implements mitigation strategies
  • Ensures Clinical Team compliance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety.
  • Demonstrated capability to supervise and mentor less experienced personnel.

Requirements:
Education:
  • M.D. degree, or
  • Ph.D. degree, post-doctoral experience preferred, or
  • Bachelor's degree in biomedical subject, master's degree preferred.
Experience
  • 0-3 years prior industry experience or clinical practice experience, preferably in a research/academic setting
  • Training in analysis of clinical and basic research information
  • Effective communications (verbal & written) and presentation skills are essential.
  • Must be able to work productively in a fast-paced collaborative environment.
  • Demonstrated/potential for critical thinking skills and sound decision-making

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.

Requisition Number: 12993BR