Staff Scientist, Clinical Pharmacology - Tarrytown
Compensation: $120,440.00 - $159,620.00 /year *
Employment Type: Full-Time
Industry: Scientific Research
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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.
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.
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
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
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.
Associated topics: aseptic technique, food, immunology, industrial hygienist, microbiology, nephrology, physiologist, protein, therapeutic, trauma
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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