Senior Principal Scientist Development DMPK

Working with Us

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.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more:

Senior Principal Scientist - DMPK Project Representative

When you join BMS, you are joining a diverse, high-achieving team united by a common mission.

The Pharmaceutical Candidate Optimization organization at Bristol Myers Squibb is a dynamic, multi-disciplinary department that works to discover and optimize new drug candidates. We work across all therapeutic areas and all modalities (small molecules, biotherapeutics, gene and cell therapies and other novel modalities), and engage with all other R&D functions to advance new assets in the BMS portfolio. Our integrated, cross-functional teams apply deep expertise in drug metabolism, pharmacokinetics (DMPK), toxicology, pharmaceutics, and bioanalysis to identify and solve issues, discover high quality drug candidates, and enable their clinical development.

Within the Pharmaceutical Candidate Optimization (PCO) organization at BMS, the Development DMPK Team provides ADME (absorption, distribution, metabolism, and excretion) 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 Scientific Associate Director to join the Dev DMPK group that is an expert in ADME and pharmaceutical drug development of small molecule and protein therapeutics. In this role, you will represent the Dev DMPK function on cross-functional development project teams; oversee developmental drug disposition metabolism and non-clinical pharmacokinetics activities of multiple projects; be responsible for preparation of regulatory dossier/responses;

and assist in developing strategy for the group. You will collaborate with discovery team in PCO, Toxicology, Biopharmaceutic, Bioanalytical, Clinical Pharmacology to ensure transition from discovery to First-In-Human and address drug development issues.

Key Responsibilities

In the role, the ideal candidate:

* 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.

* Support 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.

Basic Qualifications:

* Bachelor's Degree with 10+…