Principal / Senior Principal Scientist (DMPK Project Representative) (R1559683-en-us)
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.
The (Sr) Principal Scientist should have experience in DMPK and pharmaceutical drug development. They will represent the Nonclinical Disposition and Bioanalysis (NDB) function on cross-functional project teams; with guidance, be responsible for preparation of regulatory dossier/responses; and oversee developmental drug metabolism and non-clinical pharmacokinetics activities of multiple projects. They will collaborate with Clinical Pharmacology, Toxicology, and Formulation groups to address drug development issues associated with drug candidates.
Responsibilities will include, but are not limited to, the following:
Represent NDB on cross-functional project teams, including assisting in the preparation of project strategies and development plans.
With guidance, write and review submission documents such as CTD sections for INDs and NDAs, Investigator Brochures, briefing books, etc. to support clinical trials and global drug registrations.
Oversee internal and outsourced drug metabolism and PK activities, 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.
Work with colleagues to expand department capabilities and improve processes.
Qualifications & Skills
MS or PhD degree in biochemistry, chemistry, biology or related fields, with 15 (MS) or 5 (PhD) years of relevant drug development experience within the pharmaceutical industry.
Requires expertise in drug metabolism and pharmacokinetics and an understanding of drug development.
Previous experience as a drug metabolism project team representative is preferred.
Understanding of DMPK and drug development
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 working with interdisciplinary project teams, including assisting in the development of 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, is a plus.
Strong written and verbal communication skills, and computer proficiency required.
Experience with PK/PD and/or PBPK modeling is a plus.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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