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. 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: careers.bms.com/working-with-us . 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.
- 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 research plus 2+ years of leadership experience.
- Extensive expertise in drug disposition, DDI and small molecule therapeutics, including understanding of techniques used to characterize ADME/PK properties of drug candidates.
- Hands-on experience with PBPK modeling to predict drug interactions and human PK profiles is a plus.
- A thorough understanding of drug development of small molecule therapeutics, biologics and new modalities including ADCs
- Effective in independently working with multidisciplinary 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 overseeing studies performed internally or at external CROs.
- Strong written and verbal communication skills.
With a single vision as inspiring as Transforming patients' lives through science⢠, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected] . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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