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Company

Original Job Post

Bristol Myers Squibb · 3 days ago

Sr. Principal Scientist DMPK Project Representative

Princeton, NJ

Full-time

Hybrid

Senior Level

8+ years exp

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Responsibilities

Represents Dev DMPK on cross-functional development project teams for biologics and small molecule therapeutics, including preparing project strategies and development plans.

Oversees internal and outsourced nonclinical drug metabolism and PK activities on multiple projects, including study design, data interpretation, report preparation.

Writes and critically reviews nonclinical submission documents such as CTD sections for INDs and NDAs/BLAs, Investigator Brochures, briefing books, DSUR, etc. to support clinical trials and global drug registrations. Interacts with regulatory authorities to address questions as needed.

Supports clinical assets for all ADME and PK related inquiries and activities.

Assists in guiding department strategy. Supervising and/or mentoring junior scientists may also be required.

Qualification

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PK/PD ModelingDrug DispositionADME PropertiesTMDDADABioanalysisDrug DevelopmentRegulatory RequirementsClinical PharmacologyProject ManagementProblem-SolvingInterpersonal Communication

Required

Bachelor's Degree with 10+ years of academic and / or industry experience

OR Master's Degree with 8 + years of academic and / or industry experience

OR Ph.D. or equivalent advanced degree in the Life Sciences with 6 + years of academic and / or industry experience. Plus 2 years of leadership experience.

Experience with preclinical PK and PK/PD modeling for biologics is a plus.

Extensive expertise in drug disposition and small molecule therapeutics, including understanding of in vitro and in vivo techniques used to characterize ADME properties of drug candidates, and factors that impact large molecule PK (TMDD and ADA).

A thorough understanding of drug development of biologics and small molecule therapeutics

Working knowledge of bioanalysis.

Working knowledge of PK/PD concepts and models, as well as proficiency in human PK and dose prediction.

Effective at independently working with interdisciplinary project teams, including developing ADME strategies and implementing drug development plans.

Understanding of regulatory requirements in the areas of drug metabolism, drug-drug interactions, bioanalysis, toxicology, and clinical pharmacology.

Experience preparing drug metabolism reports and regulatory submission documents.

Experience overseeing studies performed internally or at external CROs.

Strong written and verbal communication skills.

Preferred

PhD degree in pharmaceutics, biochemistry, chemistry, biology or related fields, and 8+ or more years of relevant drug discovery and development experience within the pharmaceutical Plus 2+ years of leadership experience

Benefits

Competitive benefits

Services and programs

Resources for personal goals

Company

Bristol Myers Squibb

Glassdoor

3.8

At Bristol Myers Squibb, we work every day to transform patients’ lives through science.

Founded in 1887

New York, New York, USA

10,001+ employees

http://www.bms.com

H1B Sponsorship

Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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