Responsibilities:
- Oversee nonclinical safety evaluation programs for selected drug candidates.
- Design and ensure timely reporting of toxicity studies (GLP/nonGLP), including single- and repeat-dose toxicity, investigative toxicity, and other toxicity studies as required.
- Serve as a Nonclinical Safety representative on early- and late-stage project development teams.
- Provide scientifically and strategically sound nonclinical development plans to management and development teams.
- Interact with regulatory agencies worldwide (as needed) on nonclinical safety evaluation.
- Write and critically review submission documents (e.g., CTD sections for INDs/NDAs, IBs, PIPs, briefing books).
- Participate in discussions with internal teams and/or regulatory agencies to address safety findings and provide safety assessments.
- Evaluate, propose, and apply new scientific methodology to enhance scientific excellence and/or productivity; collaboratively identify/characterize/resolve target/compound-based toxicities.
- Represent the company in external scientific and regulatory collaborations, committees, and consortia.
- Collaborate with Discovery to help evaluate toxicity of drug candidates.
- Ensure compliance with GLP, SOPs, and study protocols (when applicable), and with company/departmental policies, especially those related to animal welfare and safety.
Basic Qualifications:
- Bachelor’s degree and 15+ years academic/industry experience, or
- Master’s degree and 12+ years academic/industry experience, or
- PhD and 8+ years academic/industry experience
- Plus 6+ years of leadership experience
Preferred Qualifications:
- 10+ years regulatory toxicology/development experience.
- Knowledge of biochemical/mechanistic toxicology, immunology, pharmacology, biology of disease, and/or experimental pathology; experience designing/interpreting in vitro and in vivo mechanism-of-toxicity studies with biochemical/immunological/functional/molecular/structural endpoints.
- Effective written and oral communication skills for clear documents and data presentation.
- Ability to manage multiple research activities, collaborate on data interpretation, and work well in teams.
- Ability to interpret/apply toxicity data to assess relative risk or hazard to humans.
Benefits:
- Health Coverage (medical, pharmacy, dental, vision)
- Wellbeing Support (e.g., BMS Well-Being Account, BMS Living Life Better, EAP)
- Financial Well-being and Protection (401(k), disability, life/accident insurance, supplemental health, business travel protection, personal liability, identity theft benefit, legal and survivor support)
- Paid Time Off (flexible time off for US exempt employees; vacation/national holidays/options for certain hourly/exempt groups, plus other eligible time off such as paid sick time, volunteer days, leaves of absence, and Global Shutdown)