Director GSCM Network & Demand Center managing global supply chain activities at Bachem, an innovation - driven company specializing in peptides and oligonucleotides.
About the role
- Project Toxicologist overseeing nonclinical safety evaluation programs for drug candidates at Bristol Myers Squibb. Involves regulatory interaction, planning, and compliance with safety assessments.
Responsibilities
- Is 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.
- Represents BMS in external scientific and regulatory collaborations, committees and consortia.
- Gains broad-based exposure to the various functional areas within Nonclinical Safety with an opportunity to perform independent research as appropriate.
- Collaborates with the Discovery organization to help evaluate toxicity of drug candidates.
- Ensures compliance with Good Laboratory Practice, Standard Operating Procedures, and study protocols in conducting nonclinical studies, when applicable.
- Ensures compliance with all company/departmental policies, particularly those relating to animal welfare and safety.
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.
Benefits
- Health Coverage: Medical, pharmacy, dental, and vision care.
- Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
- Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
- Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
- Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
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