Scientific Associate Director - Toxicology

Bristol Myers Squibb•New Brunswick, NJ

4d•$178,690 - $249,003•Hybrid

About The Position

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. 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 . Nonclinical Safety (NCS), within Nonclinical Research and Biotherapeutics, is responsible for designing and implementing overall nonclinical safety strategy to support the development and eventual marketing approval and post-marketing safety for the breadth of the BMS portfolio in oncology, hematology, cardiovascular disease, fibrosis, immunology and neurology. Located in any of our sites (New Brunswick, Lawrenceville, Princeton, NJ; San Diego, Brisbane, CA; Cambridge, Mass; Seattle, WA) NCS members work with discovery and development colleagues, as well as health authorities across the country and the world, to bring innovative and impactful medicines to patients around the globe. Level dependent on experience. Position Overview In the role as a Project Toxicologist , the ideal candidate: Is responsible for the oversight of the nonclinical safety evaluation programs for selected drug candidates. Assists in the proper design and timely reporting of toxicity studies (GLP/nonGLP), including single- and repeat-dose toxicity, investigative toxicity, and other toxicity studies as required. Act as a Nonclinical Safety representative on early- and late-stage project development teams. Provides scientifically and strategically sound nonclinical development plans to management and development teams. On an as-needed basis, interacts with regulatory agencies worldwide on issues of nonclinical safety evaluation. Writes and critically reviews submission documents, such as CTD sections for INDs and NDAs, IBs, PIPs, briefing books to support clinical trials and drug registration globally. Participates in discussions with internal development teams and/or regulatory agencies to address safety findings and provide safety assessments. Evaluates, proposes, and applies new scientific methodology to enhance scientific excellence and/or productivity in Nonclinical Safety. Works collaboratively across disciplines to identify, characterize, and resolve target/compound based toxicities. Represents BMS in external scientific and regulatory collaborations, committees and consortia. Gains broad-based exposure to the various functional areas within Nonclinical Safety with an opportunity to perform independent research as appropriate. Collaborates with the Discovery organization to help evaluate toxicity of drug candidates. Ensures compliance with Good Laboratory Practice, Standard Operating Procedures, and study protocols in conducting nonclinical studies, when applicable. Ensures compliance with all company/departmental policies, particularly those relating to animal welfare and safety. Embraces/demonstrates BMS Core Values to create an atmosphere of scientific excellence, open communication, and creativity in order to maximize productivity.

Requirements

Bachelor's Degree and 15+ years of academic / industry experience or Master's Degree and 12+ years of academic / industry experience or PhD and 8+ years of academic / industry experience
Plus 6+ years of leadership experience

Nice To Haves

10+ years regulatory toxicology/development experience.
Knowledge of biochemical and mechanistic toxicology, immunology, pharmacology, biology of disease, and/or experimental pathology.
Experience designing and interpreting in vitro and in vivo studies exploring mechanisms of toxicology involving biochemical, immunological, functional, molecular, and/or structural endpoints.
Effective written and oral communication skills, especially as they pertain to writing clear, and accurate documents and presenting data.
Individual must be able to manage multiple research activities, provide and accept input on data interpretation, foster a spirit of team effort, and be able to work well with others.
Ability to interpret and apply available toxicity data to assess relative risk or hazard to humans.

Responsibilities

Is responsible for the oversight of the nonclinical safety evaluation programs for selected drug candidates.
Assists in the proper design and timely reporting of toxicity studies (GLP/nonGLP), including single- and repeat-dose toxicity, investigative toxicity, and other toxicity studies as required.
Act as a Nonclinical Safety representative on early- and late-stage project development teams.
Provides scientifically and strategically sound nonclinical development plans to management and development teams.
On an as-needed basis, interacts with regulatory agencies worldwide on issues of nonclinical safety evaluation.
Writes and critically reviews submission documents, such as CTD sections for INDs and NDAs, IBs, PIPs, briefing books to support clinical trials and drug registration globally.
Participates in discussions with internal development teams and/or regulatory agencies to address safety findings and provide safety assessments.
Evaluates, proposes, and applies new scientific methodology to enhance scientific excellence and/or productivity in Nonclinical Safety.
Works collaboratively across disciplines to identify, characterize, and resolve target/compound based toxicities.
Represents BMS in external scientific and regulatory collaborations, committees and consortia.
Gains broad-based exposure to the various functional areas within Nonclinical Safety with an opportunity to perform independent research as appropriate.
Collaborates with the Discovery organization to help evaluate toxicity of drug candidates.
Ensures compliance with Good Laboratory Practice, Standard Operating Procedures, and study protocols in conducting nonclinical studies, when applicable.
Ensures compliance with all company/departmental policies, particularly those relating to animal welfare and safety.
Embraces/demonstrates BMS Core Values to create an atmosphere of scientific excellence, open communication, and creativity in order to maximize productivity.

Benefits

wide variety of competitive benefits, services and programs
Medical, pharmacy, dental and vision care.
Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
Financial well-being resources and a 401(K).
Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
Parental, caregiver, bereavement, and military leave.
Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
Other perks like tuition reimbursement and a recognition program.

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