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Senior Toxicology Expert

2 months ago


Rahway, New Jersey, United States MSD Malaysia Full time
Job Description

Job Title: Principal Scientist, Toxicologist/Study Director

Job Summary:

MSD Malaysia is seeking a highly skilled and experienced Toxicologist to join our Nonclinical Drug Safety department. As a Principal Scientist, Toxicologist/Study Director, you will be responsible for conducting and/or monitoring toxicity studies, serving as a Study Director or Study Monitor, and potentially representing the department on product development teams.

Key Responsibilities:

  • Study Direction: Serve as the single point of control on assigned acute through chronic general toxicology studies across all modalities.
  • Data Analysis and Interpretation: Critically analyze and interpret data, integrating findings from other areas into written reports used for regulatory submissions.
  • Team Collaboration: Participate on cross-functional group teams to investigate mechanisms of toxicity, utilizing additional tools and applications available on site.
  • Regulatory Strategy: Potentially serve as a departmental representative on a product development team, overseeing the strategy and design of nonclinical safety studies and generating regulatory strategies and communications with global regulatory agencies.
  • Ophthalmic Examinations: Conduct nonclinical ophthalmic examinations (GLP and non-GLP) on a variety of species depending on experience and interest.

Requirements:

  • Education: PhD and/or DVM with graduate and/or post-graduate work training in toxicology, pharmacology, or related scientific discipline.
  • Experience: Minimum of 5 (five) years of relevant experience as a Toxicologist or Study Director in pharma, biotech, or at a CRO.
  • Skills: Demonstrated understanding of and experience with Good Laboratory Practices (US FDA 21 CFR Part 58), strong interest in collaborating with diverse cross-functional teams, and ability to communicate clearly using verbal and written formats.

Preferred Qualifications:

  • Ophthalmic Expertise: Expertise in ophthalmic examinations or expertise/knowledge in ophthalmology (e.g., anatomy, pharmacology, or toxicology).
  • Study Monitoring: Familiarity with outsourced study monitoring.
  • Product Development: Experience serving as a representative on a product development team.
  • Veterinary Medicine: Background in veterinary medicine or experience working with laboratory animals.