Director of IBP optimizing planning processes at Smith+Nephew. Leading deployment of SIOP/IBP governance and driving cross - functional alignment for business objectives.
About the role
- Project Toxicologist at Bristol Myers Squibb overseeing nonclinical safety evaluation programs for drug candidates. Responsible for toxicity study design and reporting, team collaboration, and regulatory interactions.
Responsibilities
- 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.
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
- 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,
- Ability to interpret and apply available toxicity data to assess relative risk or hazard to humans.
Benefits
- 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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