Head Of Genetic Toxicology
Bristol Myers Squibb
**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: careers.bms.com/working-with-us .
Genetic Toxicology is a group of 4 subject matter experts in the areas of genetic toxicology and product quality reporting the Scientific Vice President of Nonclinical Safety, responsible for:
+ Have responsibility to conduct and monitor nonGLP and GLP genetic toxicology in support of BMS product development activities.
+ Support selection of lead molecules to progress from discovery into development by evaluating candidates for genotoxic potential and advising Discovery Toxicology Project teams on strategy for advancing lead candidates into further consideration for clinical development.
+ Identify genetic health hazards via in silico, in vitro and in vivo testing to support drug development, worker safety, and safety data sheet generation.
+ Conduct toxicology risk assessments for impurities.
+ Support multiple groups throughout BMS including corporate EOHSS, CMC, CSD, Discovery, GMS, etc.
+ Scientific and operational leadership of Genetic Toxicology supporting drug development, worker safety and chemical registrations. Subject matter expert providing oversite of internal/external genotoxicity studies, in silico impurity hazard assessment and establishment of patient and worker exposure limits (with Occupational Toxicology Group) for API, synthetic intermediates/reagents/raw materials, degradants and impurities/contaminants.
+ Lead development and implement innovative technologies and strategies for testing, risk evaluation and mechanistic understanding of potential/actual genotoxic liabilities.
+ Build strong collaborations across Process Chemistry, Discovery, and Nonclinical toxicology ensuring effective risk assessment and control strategies.
+ External recognition as a key opinion leader as evidenced by active participation/leadership roles in professional societies, trade associations and cross industry-regulatory special issue work groups.
+ Create and maintain an atmosphere of scientific excellence, open communication, inclusivity, and innovation to maximize productivity and encourage employee career development.
+ Continuous improvement in methods and techniques to refine, and reduce animal use while maintaining effective hazard assessment and exposure limit derivation.
**Responsibilities**
+ Provide scientific and operational leadership to the Genetic Toxicology functions to support BMS drug development and employee safety and chemical registrations.
+ Provide subject matter expertise (SME) in the areas of genetic toxicology and impurity hazard assessments; managing assignment of appropriate impurity limits to ensure patient and worker safety.
+ Develop genotoxicity and impurity strategy in support of BMS drug development, maintaining knowledge of current thinking and trends in Health Authority thinking for genotoxicity and drug substance/product impurities
+ Review study protocols and reports to ensure compliance with ICH, OECD, and GLPs in addition to sound study design and data interpretation.
+ Active member of the mutagenic impurities action committee (MIAC), the small molecule forum, the specifications committee, and the industrial toxicology committee. Contribute knowledge and make recommendations on topics pursuant to the goals of these groups.
+ Maintain external recognition as a key opinion leader as evidenced by active participation/leadership roles in national professional societies, trade-association focus groups, and organizations with missions to further human safety and to address genetic toxicology specific issues in drug development (e.g. PhRMA, EFPIA, HESI GTTC, EMSG, GTA, SOT, the toxicology forum, etc).
+ Provide scientific collaboration to exploratory and discovery groups within Research and Development to help evaluate and nominate drug candidates with minimal or predictable toxicity profiles.
+ Create and maintain an atmosphere of scientific excellence, open communication, inclusivity, and innovation to maximize productivity and encourage employee career development.
+ Ensure compliance with Good Laboratory Practice regulations, Standard Operating Procedures, administrative policies, and study protocols for GOT. Ensure compliance with all company/departmental policies, particularly those relating to animal welfare and employee health and safety.
+ Create an atmosphere of scientific excellence, open communication, and creativity in order to maximize productivity.
+ Embrace/demonstrate BMS Core Behaviors.
+ Provide overall supervision of the Genetic Toxicology group.
**Degree Requirements**
+ PhD degree in Toxicology, or related discipline
**Experience Requirements**
+ Minimum of 10 years pharmaceutical experience (preferably with supervisory experience).
**Key Competency Requirements**
+ Advanced understanding of genotoxic modes of action and ability to evaluate toxicological and QSAR data to identify and communicate actual and potential toxicological risks
+ Lead development and implement innovative technologies and strategies for testing, risk evaluation and mechanistic understanding of potential/actual genotoxic liabilities.
+ Experience conducting chemical risk assessments, assigning control limits, and explaining/defending decisions to management and Health Authorities
+ Advanced understanding of pertinent international Health Authority Guidelines (ICH, OECD TG, REACH, etc) and regulations to ensure compliance and acceptance of submitted data
+ Ability to lead and contribute to cross-functional teams to achieve department and corporate objectives.
+ Effective written and oral communication skills.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Uniquely Interesting Work, Life-changing Careers**
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 an inclusive culture, promoting diversity 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 a diverse 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 adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) 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: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
**Company:** Bristol-Myers Squibb
**Req Number:** R1590561
**Updated:** 2025-03-26 04:04:45.318 UTC
**Location:** New Brunswick-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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