Scientific Associate Director - Toxicology
Bristol Myers Squibb
6 hours ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Position Overview (Project Toxicologist)
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 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 and NDAs, Investigator’s Brochures, PIPs, briefing books) to support clinical trials and global drug registration.
- Participate in internal and/or regulatory discussions to address safety findings and provide safety assessments.
- Evaluate, propose, and apply new scientific methodology to enhance nonclinical safety scientific excellence and/or productivity.
- Collaborate across disciplines to identify, characterize, and resolve target/compound-based toxicities.
- Represent BMS in external scientific and regulatory collaborations, committees, and consortia.
- Gain broad exposure to functional areas within Nonclinical Safety, with opportunity for independent research as appropriate.
- Collaborate with the Discovery organization to evaluate toxicity of drug candidates.
- Ensure compliance with GLP, Standard Operating Procedures, and study protocols (when applicable), including company/department policies related to animal welfare and safety.
Basic Qualifications:
- 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.
Preferred Qualifications:
- 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/in vivo mechanistic toxicology studies across biochemical, immunological, functional, molecular, and/or structural endpoints.
- Effective written and oral communication skills for accurate documents and data presentation.
- Ability to manage multiple research activities; provide/accept input on data interpretation; foster team effort; work well with others.
- Ability to interpret and apply toxicity data to assess relative risk or hazard to humans.
Compensation / Benefits (as stated):
- Starting compensation ranges listed by location (FTE basis) and possible incentive cash/stock opportunities (based on eligibility).
- Health Coverage: medical, pharmacy, dental, vision.
- Wellbeing Support: Well-Being Account, Living Life Better, EAP.
- Financial Well-being and Protection: 401(k), disability, life insurance, accident insurance, supplemental health insurance, travel protection, personal liability protection, identity theft benefit, legal support, survivor support.
- Work-life benefits include Paid Time Off and location-dependent holiday/vacation terms; additional time off may include paid sick time, volunteer days, summer hours flexibility, leaves of absence, and an annual Global Shutdown (per eligibility).
Application Instructions:
- Apply if the role is of interest even if experience does not perfectly align.
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 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 and NDAs, Investigator’s Brochures, PIPs, briefing books) to support clinical trials and global drug registration.
- Participate in internal and/or regulatory discussions to address safety findings and provide safety assessments.
- Evaluate, propose, and apply new scientific methodology to enhance nonclinical safety scientific excellence and/or productivity.
- Collaborate across disciplines to identify, characterize, and resolve target/compound-based toxicities.
- Represent BMS in external scientific and regulatory collaborations, committees, and consortia.
- Gain broad exposure to functional areas within Nonclinical Safety, with opportunity for independent research as appropriate.
- Collaborate with the Discovery organization to evaluate toxicity of drug candidates.
- Ensure compliance with GLP, Standard Operating Procedures, and study protocols (when applicable), including company/department policies related to animal welfare and safety.
Basic Qualifications:
- 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.
Preferred Qualifications:
- 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/in vivo mechanistic toxicology studies across biochemical, immunological, functional, molecular, and/or structural endpoints.
- Effective written and oral communication skills for accurate documents and data presentation.
- Ability to manage multiple research activities; provide/accept input on data interpretation; foster team effort; work well with others.
- Ability to interpret and apply toxicity data to assess relative risk or hazard to humans.
Compensation / Benefits (as stated):
- Starting compensation ranges listed by location (FTE basis) and possible incentive cash/stock opportunities (based on eligibility).
- Health Coverage: medical, pharmacy, dental, vision.
- Wellbeing Support: Well-Being Account, Living Life Better, EAP.
- Financial Well-being and Protection: 401(k), disability, life insurance, accident insurance, supplemental health insurance, travel protection, personal liability protection, identity theft benefit, legal support, survivor support.
- Work-life benefits include Paid Time Off and location-dependent holiday/vacation terms; additional time off may include paid sick time, volunteer days, summer hours flexibility, leaves of absence, and an annual Global Shutdown (per eligibility).
Application Instructions:
- Apply if the role is of interest even if experience does not perfectly align.