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Ensures that toxicology studies and programs are conducted in accordance with the appropriate guidelines and regulatory test standards (FDA, WHO, GLP, and ISO). Senior Scientific Director, Toxicology About the Role:As a Sr. Leader, executes the strategic direction of the Toxicology function.
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Experience in or potential to adapt to an ISO, GMP, or GLP environment. Familiarity with guidelines such as good manufacturing processes and ISO standards. Laboratory experience (synthetic organic chemistry preferred over biochemistry/bio but willing to review all laboratory resumes.
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Advises and directs the preparation of Safety Pharmacology and Toxicology sections of regulatory documents (IND, CTA, NDA, briefing books, Investigator Brochures, etc.) Represent Preclinical development on discovery and development teams and regularly interfaces with internal and external colleagues to ensure timely and accurate dissemination of Safety Pharmacology and Toxicology findings.
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Advises and directs the analysis, interpretation and reporting of Safety Pharmacology and Toxicology data for discovery and development programs. Designs and develops overall Safety Pharmacology and Toxicology development strategies for toxicology programs.
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Oversees and evaluates protocol preparation for toxicology studies and reviews reports. Supports Sr. Leadership with in-life resource planning, maintaining current testing procedures, program development, performance monitoring, budget planning and resource management.
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Provides strategic and operational direction ensuring that toxicology studies are conducted in line with the appropriate guidelines and regulatory test standards (FDA, WHO, GLP, and ISO). Oversee and provide direction in the preparation of Safety Pharmacology and Toxicology sections of regulatory documents (IND, CTA, NDA, briefing books, Investigator Brochures, etc.
$340,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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PhD in Toxicology, Pathology or closely related discipline and 12+ years of pharmaceutical/biotech experience, including managing clinical Contract Research Organizations. Works in collaboration with other Research and Development Team members and with Neurocrine leadership to ensure safety pharmacology and toxicology support is provided to ensure provision of requisite data in a timely manner to meet development goals.
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Possesses industry-leading knowledge of Toxicology assessment of small molecules and biologics. Represent Preclinical Development on discovery and development-stage program teams. in collaboration with AbbVie.
$366,875 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Experience with applicable GMP, ISO regulations, and knowledge of federal and state environmental and occupational safety and health regulations (EPA, OSHA, NFPA). The EHS Multi-Site Leader is responsible for management and performance of the Environmental, Health, and Safety function for the designated sites.
$220,800 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Familiarity with common standards, frameworks, and regulations such as: NIST, ISO, COBIT, SIG, CCM, SOC-2, FAIR, HITRUST, PCI, GDPR. Able to function independently and perform routine tasks such as: Facilitate meetings, organize conference calls, deliver presentations, and so forth.
$130,843.64 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Preferred Qualifications Experience in the field of video streaming, including commonly used streaming protocols such as HLS, DASH etc Experience using the CoreFoundation, AVFoundation and/or CoreMedia frameworks or equivalent technologies Knowledge of associated media file formats standards (ISO base media file format, CMAF, fMP4, MPEG-2 TS)Pay & BenefitsAt Apple, base pay is one part of our total compensation package and is determined within a range.
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Ensure facility compliance with applicable regulations, guidelines, and standards related to animal care and use (e.g., USDA, FDA, ISO, and AAALAC) Assist the Attending Veterinarian in managing the clinical care of animals in the vivarium as needed.
$125,000 - $140,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Critically evaluate toxicology results and provides timely strategic advice to project teams and senior management on the potential impact of toxicology results on Program and Clinical/Regulatory strategy ·Oversee and provide direction in the preparation of Safety Pharmacology and Toxicology sections of regulatory documents (IND, CTA, NDA, briefing books, Investigator Brochures, etc.
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Educates and supervises staff to ensure compliance with applicable Inova SOPs, ISO, FDA and other Quality System Regulations, as well as applicable Environmental, Health & Safety, Human Resources and all other regulatory and administrative policies.
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Represent Preclinical Development on discovery and development-stage program teams ·Develops critical insights from data summaries and shapes presentations of results to peers, colleagues and Company Management.
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