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AD, Toxicology As a scientific leader, will develop and lead Toxicology/Safety Pharmacology projects, oversees studies from planning through to final reporting. Participates in formulating the strategic and operational direction of the function ensuring all studies are conducted in line and adhere to appropriate guidelines and regulatory testing standards and individual program objectives. Recommend scientific strategies for overall programs and/or department. Represents Toxicology on Development teams and may advise senior technical leadership of Toxicology/Safety pharmacology findings and recommendations.Important requirement: experience: Authors and/or reviews Toxicology and Safety Pharmacology sections of all regulatory documents, including IND, CTA, IB, annual report, and NDA/MAA submissions_ Your Contributions (include, But Are Not Limited To)
Participates in formulating scientific strategies and leads the execution in order to develop and implement plans for preclinical testing of new and current drug candidates Drive the identification, evaluation, selection and management Toxicology and Safety Pharmacology CROs, act as technical expert and ensure CROs have sufficient capabilities, resources to executes against contractual obligations Evaluate and implement protocol preparation for assigned Toxicology and Safety Pharmacology studies. Manages the conduct and reporting of individual studies, including study placement, contract development/budgeting, coordination of pre-study activities, and approving study protocols and reports Continuously performs extensive analyses/interpretations of Toxicology/Safety Pharmacology data and serves as a key opinion leader(s) making a go/no-go decision Proactively recommends and drives process optimizations and SOP changes as needed to guide the Toxicology and Safety Pharmacology programs. Proactively researches and stays current with regulatory guidance, keeps key stakeholders aware of potential changes Works collaboratively with other scientists, technicians and colleagues as part of multidisciplinary project teams Own preparation of documents and annual investigational new drug and new drug application reports Authors and/or reviews Toxicology and Safety Pharmacology sections of all regulatory documents, including IND, CTA, IB, annual report, and NDA/MAA submissions Independently performs quality control checks on non-clinical pharmacology and toxicology documents for regulatory submission May provide support to build and maintain technical databases, archives and department procedures manuals Oversees lower level scientists and/or team members Will lead the development of intellectual property Performs other duties as assigned
Requirements
BS/BA in Toxicology, Pharmacology, Biology or related discipline required and 15+ years of CRO and/or pharmaceutical industry experience, including Safety Pharmacology. Experience in with oversight of small molecule Toxicology/Safety Pharmacology programs. Technical leadership experience in managing preclinical Contract Research Organizations. Extensive experience with preparation of INDs, CTDs, NDAs, and MAA OR MS/MA in Toxicology, or related discipline and 13+ years of similar experience noted above OR PhD in Toxicology or related discipline and 7+ years of similar experience noted above DABT certification is preferred Emerging as an internal thought leader with technical and/or business expertise Applies in-depth knowledge of own area of expertise to solve problems Applies expertise to manage critical projects and/or relationships Integrates analysis of business objectives and strategic direction to resolve problems and recommend solutions Has input into short-term strategy and may be involved in long-term strategy on a functional level Strong communications, problem-solving, analytical thinking, influencing skills. Strong expertise in Safety Pharmacology, Toxicology, Pathology or other other related specialization Demonstrated oversight of small molecule or gene therapy Toxicology/Safety Pharmacology programs Expert and current knowledge of ICH and FDA guidance Demonstrated technical leadership experience in managing preclinical Contract Research Organizations Extensive experience with preparation of INDs, CTAs, NDAs, and MAAs Proactive, innovative, with exceptional problem-solving skills Demonstrated experience working in a cross functional team and matrix environment
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Participates in formulating scientific strategies and leads the execution in order to develop and implement plans for preclinical testing of new and current drug candidates Drive the identification, evaluation, selection and management Toxicology and Safety Pharmacology CROs, act as technical expert and ensure CROs have sufficient capabilities, resources to executes against contractual obligations Evaluate and implement protocol preparation for assigned Toxicology and Safety Pharmacology studies. Manages the conduct and reporting of individual studies, including study placement, contract development/budgeting, coordination of pre-study activities, and approving study protocols and reports Continuously performs extensive analyses/interpretations of Toxicology/Safety Pharmacology data and serves as a key opinion leader(s) making a go/no-go decision Proactively recommends and drives process optimizations and SOP changes as needed to guide the Toxicology and Safety Pharmacology programs. Proactively researches and stays current with regulatory guidance, keeps key stakeholders aware of potential changes Works collaboratively with other scientists, technicians and colleagues as part of multidisciplinary project teams Own preparation of documents and annual investigational new drug and new drug application reports Authors and/or reviews Toxicology and Safety Pharmacology sections of all regulatory documents, including IND, CTA, IB, annual report, and NDA/MAA submissions Independently performs quality control checks on non-clinical pharmacology and toxicology documents for regulatory submission May provide support to build and maintain technical databases, archives and department procedures manuals Oversees lower level scientists and/or team members Will lead the development of intellectual property Performs other duties as assigned
Requirements
BS/BA in Toxicology, Pharmacology, Biology or related discipline required and 15+ years of CRO and/or pharmaceutical industry experience, including Safety Pharmacology. Experience in with oversight of small molecule Toxicology/Safety Pharmacology programs. Technical leadership experience in managing preclinical Contract Research Organizations. Extensive experience with preparation of INDs, CTDs, NDAs, and MAA OR MS/MA in Toxicology, or related discipline and 13+ years of similar experience noted above OR PhD in Toxicology or related discipline and 7+ years of similar experience noted above DABT certification is preferred Emerging as an internal thought leader with technical and/or business expertise Applies in-depth knowledge of own area of expertise to solve problems Applies expertise to manage critical projects and/or relationships Integrates analysis of business objectives and strategic direction to resolve problems and recommend solutions Has input into short-term strategy and may be involved in long-term strategy on a functional level Strong communications, problem-solving, analytical thinking, influencing skills. Strong expertise in Safety Pharmacology, Toxicology, Pathology or other other related specialization Demonstrated oversight of small molecule or gene therapy Toxicology/Safety Pharmacology programs Expert and current knowledge of ICH and FDA guidance Demonstrated technical leadership experience in managing preclinical Contract Research Organizations Extensive experience with preparation of INDs, CTAs, NDAs, and MAAs Proactive, innovative, with exceptional problem-solving skills Demonstrated experience working in a cross functional team and matrix environment
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