This position will provide Preclinical Safety a wide range of support associated with Toxicology and Safety Pharmacology needs on Discovery and Development Project Teams for Group projects. This position would provide scientific expertise across the drug discovery and development value chain on biotherapeutics and small molecules. Activities include, but are not limited to:
- Serve as Preclinical Safety Project Team Representative on multi-disciplinary Discovery and Development teams responsible for the progression of both biotherapeutics and small molecule drug candidates for regulatory submissions. These activities include designing and coordinating a multi-disciplinary effort to support such projects through the development of the nonclinical safety strategy and program which includes, but is not limited to attending various project team meetings; the design and interpretation of toxicity studies; the preparation and/or review of written preclinical safety reports; and the authoring of the nonclinical document sections for regulatory submissions.
- Serve as internal biotherapeutics expert for scientific issues related to nonclinical safety issues related to the development of these molecules.
- Interact with multiple functions (Pharmacology, Regulatory Affairs, Clinical, Project Leaders & Managers, etc.) on a daily basis.
- Involved with the multiple Community of Practice groups in preclinical safety and provide input to address safety issues; including design and conduct of investigative studies in support of the toxicological evaluation of compounds.
- Participate in Preclinical Safety Department activities (staff meeting, scientific forums, etc.), and special projects.
- Participate in special projects or inter-industry working groups, as needed. Provide scientific input on design and analysis of research activities.
- Ensure high scientific standards and adhere to requested timelines in all aspects of the position.
Qualifications
Basic Qualifications:
PhD or DVM and post-doctoral experience.
Experience in development of biotherapeutics is required.
6-8 years of relevant industry experience.
Knowledgeable about GLP policies and/or regulatory nonclinical testing requirements for pharmaceutical development of biotherapeutics and small molecules.
Preparation of regulatory documents for submission to health authorities.
Additional Information
All your information will be kept confidential according to EEO guidelines.
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