Staff Scientist, Clinical Pharmacology

Location
Tarrytown, NY
Posted
Nov 09, 2019
Ref
17829BR
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:
The Clinical Pharmacologist role provides clinical pharmacology (CP) expertise to programs across all stages of drug development. The Clinical Pharmacologist is responsible for delivering comprehensive CP strategic development plans and applying quantitative-based methodologies to optimally support drug development programs.

Responsibilities:

• Contribute to comprehensive CP strategic development plans for assigned development programs

• Provide CP subject matter expertise to clinical study and project development teams in the design, conduct, and reporting of clinical trials for development programs in both early and late development

• Integrate knowledge of PK/PD, patient covariates, and disease state to optimize dose selection, dosage regimens, and study designs throughout the different stages of drug development

• In collaboration with Quantitative Pharmacology, develop and deliver modeling & simulation (M&S) strategies to support assigned development plans and inform key drug development decisions/milestones

• Supervise and/or conduct PK, PK/PD, and dose/exposure-response analyses in both early and late development

• In collaboration with preclinical PK/PD, translate preclinical data to support human PK and efficacious dose projections; provide scientific justification for optimal human starting dose and dose escalation schemes for FIH studies

• Contribute to and/or author CP sections of clinical study protocols, study analysis plans, CP study reports, clinical development plans, and scientific publications

• Contribute to regulatory strategy for CP, prepare CP contributions to regulatory documents including Investigator Brochures, IND's, briefing books, BLA and MAA submissions, post-approval filings, and responses to health authority questions

• Stay abreast of new developments in CP, drug development, regulatory, and M&S by publishing in peer-reviewed journals, attending and presenting scientific data at conferences, and participating in special interest groups within professional societies

Requirements:
Minimum Requirements

• PhD in Pharmaceutics, Biology, Pharmacology, Engineering, Pharmacy (Pharm.D.), Medicine (MD)

• 3 plus years of industry or equivalent experience in CP and/or clinical PK/PD

• Ability to analyze and critically assess PK/PD data; proficient in PK/PD software eg, WinNonlin, R, NONMEM, Monolix

• Demonstrated ability to work in a collaborative, cross-functional team environment

• Excellent verbal and written communication skills

• Self motivated, able to work independently

Preferred Qualifications

• Prior experience in PK and PK/PD of large molecule (eg, monoclonal antibodies, bispecifics, fusion proteins, antibody-drug conjugates) and/or RNA therapeutics

• Prior CP experience in infectious disease, neuroscience, or ophthalmology drug development is desired

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.