Senior Principal Scientist, Nonclinical Drug Metabolism

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Nonclinical Research and Development (NCRD) is an integrated function with responsibility for characterizing nonclinical safety and disposition characteristics of the entire BMS Research and Development pipeline programs, with critical role from early discovery to submission of marketing authorization applications. We utilize our deep expertise in toxicology/pathology, ADME, PK/PD and Bioanalytics in all modalities (small and large molecules, cellular therapies and other novel modalities) to collaborate with peer R&D functions to identify and solve issues, discover high quality drug candidates, enable their clinical development and successful marketing authorizations across the globe.

The Nonclinical Research and Development (NCRD) has an opening for a Senior Principal Scientist, Nonclinical Disposition and Bioanalysis in Lawrenceville, NJ. The Senior Principal Scientist will represent Nonclinical Disposition and Bioanalysis (NDB) function on cross-functional project teams, be responsible for preparation of regulatory dossier/responses, oversee developmental drug metabolism and non-clinical pharmacokinetics activities of multiple projects, and work with simulation and modeling software. He/she will collaborate with Clinical Pharmacology, Toxicology, and Formulation groups to address drug development issues associated with drug candidates.

Responsibilities will also include, but are not limited to, the following:

• Represent NDB on cross-functional project teams, including preparing project strategies and development plans.
• Write and critically review submission documents such as CTD sections for INDs and NDAs, Investigator Brochures, briefing books, etc. to support clinical trials and global drug registrations.
• Lead efforts in the use of modeling software (e.g. SimCYP, GastroPlus) to predict human PK and DDI potential, and address drug development issues and concerns.
• Oversee internal and outsourced drug metabolism and PK activities on multiple projects, including study design, data interpretation, and report preparation.
• Apply novel techniques and approaches to address ADME and DDI issues.
• Keep senior management apprised of project status and current scientific trends using written and oral summaries, as well as presentations.

Requirements:

• Requires PhD degree in biochemistry, chemistry, biology or related fields, and 10 or more years of relevant drug development experience within the pharmaceutical industry.
• Requires in-depth expertise in drug metabolism and pharmacokinetics and a thorough understanding of drug development.
• Experience with PK and PKPD modeling platforms (e.g. SimCYP, GastroPlus) is a plus.

Skills/Knowledge Required:

• Broad based understanding of in vitro and in vivo techniques used to characterize drug metabolism, pharmacokinetics and drug interactions potential of drug candidates.
• 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.
• Extensive experience preparing drug metabolism reports and regulatory submission documents.
• Experience overseeing studies performed internally or at external CROs.
• Strong written and verbal communication skills, computer proficiency, and experience with modeling software are required.
• Ability to multi-task and work in a collaborative team environment.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.