Senior Principal Scientist, Development DMPK

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Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

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Job Requisition: Senior Principal Scientist, Development DMPK

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Within the Pharmaceutical Candidate Optimization (PCO) organization at BMS, the Development DMPK Team provides ADME (absorption, distribution, metabolism, and excretion), DDI (drug-drug interactions) and PK (pharmacokinetics) support for all pipeline assets throughout clinical development, from candidate nomination through registration and lifecycle management. The Dev DMPK team is responsible for characterizing the ADME properties, and drug-interaction potential of drug candidates. Working closely with drug safety and clinical pharmacology, Dev DMPK plays a critical role in IND submissions and marketing authorization applications. We utilize our deep expertise in ADME and PK to collaborate with peer R&D functions to identify and solve issues, enable clinical development and successful marketing authorizations across the globe.

PCO is looking for a Senior Principal Scientist to join the Dev DMPK group that is an expert in ADME and pharmaceutical drug development of small molecule drugs and protein therapeutics. In this role, you will represent the Dev DMPK function on cross-functional development project teams; oversee developmental drug metabolism and disposition, and non-clinical pharmacokinetics activities of multiple projects; be responsible for preparation of regulatory dossier / submissions; and assist in developing strategy for the group. You will collaborate with discovery teams in PCO, Toxicology, Biopharmaceutic, Bioanalytical, Clinical Pharmacology to ensure transition from discovery to First-In-Human (FIH) and address drug development issues.

Key Responsibilities

• Represents Dev DMPK on cross-functional development project teams for small molecule therapeutics and biologics, including preparing project strategies and development plans.
• Leveraging specialized ADME/PK skills such as in vitro ADME, in vivo ADME, biotransformation, PK/PD, or physiologically based pharmacokinetic modeling (PBPK) to impact project progression and decision-making.
• Oversees internal and outsourced nonclinical drug metabolism and PK activities on multiple projects, including study design, data interpretation and presentation.
• Writes and critically reviews nonclinical submission documents such as DMPK sections for INDs and NDAs / BLAs, Investigator Brochures, briefing books, DSUR, etc. to support clinical trials and global registrations. Interacts with regulatory authorities to address questions as needed.
• Support clinical assets for all ADME, DDI and PK related inquiries and activities.
• Assists in guiding department strategy. Supervising and / or mentoring junior scientists may also be required.

Basic Qualifications:

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

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

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.

Preferred Qualifications:

• PhD degree in pharmaceu