Scientific Associate Director - Toxicology
Bristol Myers Squibb
7 hours ago
Remote friendly (Princeton, NJ)
United States
Clinical Research and Development
Position Overview (Project Toxicologist)
Responsibilities:
- Oversee nonclinical safety evaluation programs for selected drug candidates.
- Assist in the design and timely reporting of toxicity studies (GLP/nonGLP), including single- and repeat-dose toxicity, investigative toxicity, and other required toxicity studies.
- 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 on nonclinical safety evaluation issues (as needed).
- Write and critically review submission documents (e.g., CTD sections for INDs/NDAs, IBs, PIPs, briefing books) supporting clinical trials and global drug registration.
- Participate in discussions with internal development teams and/or regulatory agencies to address safety findings and provide safety assessments.
- Evaluate, propose, and apply new scientific methodology to improve scientific excellence and/or productivity; collaborate across disciplines to identify, characterize, and 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, Standard Operating Procedures, and study protocols (when applicable), including policies related to animal welfare and safety.
Basic Qualifications:
- Bachelor’s degree with 15+ years of academic/industry experience, or
- Master’s degree with 12+ years of academic/industry experience, or
- PhD with 8+ years of academic/industry experience.
- Plus 6+ years of leadership experience.
Preferred Qualifications / Skills:
- 10+ years regulatory toxicology/development experience.
- Knowledge of biochemical/mechanistic toxicology, immunology, pharmacology, biology of disease, and/or experimental pathology; experience designing and interpreting in vitro and in vivo mechanism-of-toxicity studies.
- Effective written and oral communication skills for clear documents and data presentation.
- Ability to manage multiple research activities; provide/accept input on data interpretation; work well in a team.
- Ability to interpret and apply toxicity data to assess relative risk/human hazard.
Responsibilities:
- Oversee nonclinical safety evaluation programs for selected drug candidates.
- Assist in the design and timely reporting of toxicity studies (GLP/nonGLP), including single- and repeat-dose toxicity, investigative toxicity, and other required toxicity studies.
- 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 on nonclinical safety evaluation issues (as needed).
- Write and critically review submission documents (e.g., CTD sections for INDs/NDAs, IBs, PIPs, briefing books) supporting clinical trials and global drug registration.
- Participate in discussions with internal development teams and/or regulatory agencies to address safety findings and provide safety assessments.
- Evaluate, propose, and apply new scientific methodology to improve scientific excellence and/or productivity; collaborate across disciplines to identify, characterize, and 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, Standard Operating Procedures, and study protocols (when applicable), including policies related to animal welfare and safety.
Basic Qualifications:
- Bachelor’s degree with 15+ years of academic/industry experience, or
- Master’s degree with 12+ years of academic/industry experience, or
- PhD with 8+ years of academic/industry experience.
- Plus 6+ years of leadership experience.
Preferred Qualifications / Skills:
- 10+ years regulatory toxicology/development experience.
- Knowledge of biochemical/mechanistic toxicology, immunology, pharmacology, biology of disease, and/or experimental pathology; experience designing and interpreting in vitro and in vivo mechanism-of-toxicity studies.
- Effective written and oral communication skills for clear documents and data presentation.
- Ability to manage multiple research activities; provide/accept input on data interpretation; work well in a team.
- Ability to interpret and apply toxicity data to assess relative risk/human hazard.