The Principal Scientist - Toxicology will design, execute and critically evaluate non-clinical safety studies to support the development of Glenmark's innovative products, with a focus on biopharmaceuticals. This role will represent toxicology internally and externally for non-clinical safety issues, and prepare the toxicology sections of regulatory submission documents for Glenmark's innovative products.
Design and implement toxicology studies to support the non-clinical safety of novel biopharmaceuticals (NBEs)
Collaborate with CROs in the design, data interpretation and preparation of final reports.
Research and analyze all available data relating to a specific product class or therapeutic area to development candidates
Partner directly with cross functional project teams and participate on these teams as the toxicology representative and as a team member.
Prepare and review non-clinical sections of regulatory documents
Provide toxicology support to non-biopharmaceutical products as needed
Continue career development through learning and innovation
Education:
PhD in Toxicology or related discipline strongly preferred; equivalent experience will be considered.
Experience:
6+ years experience as a toxicologist in the Pharmaceutical/Biopharmaceutical Industry required.
Knowledge of GLPs and Health Authority regulation and guidances for the development of biopharmaceuticals required.
Experience in the design and execution of the nonclinical safety assessment of biopharmaceuticals required.
Prior experience of serving as a Study Director or Study Monitor for non-clinical safety studies required.
Experience working with Contract Research Organizations.
Experience authoring the toxicology sections of regulatory documents.
Skills:
Knowledge of regulatory requirements for the non-clinical safety assessment of biopharmaceuticals.
Expert written and verbal skills.
Able to effectively communicate across functions and with external partners.
Able to work well within a team environment.
Self-motivated and able to identify and resolve problems.
Must be willing to travel.
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