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Senior Director of Toxicology (palo alto) - Biotech, R&D, & science - San francisco bay area

Ad ID: 739326
Posted by: Unregistered user
Posted on Nov 14, 2017
Expire: Feb 12, 2018
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The Senior Director will be accountable for nonclinical toxicology
They will collaborate with nonclinical pharmacokinetic and pharmacology scientists to drive the global nonclinical regulatory submission strategy

Job Responsibilities and Requirements:
• Conceptualizing, developing, revising, and finalizing toxicology (GLP and non-GLP) study designs, , and, reports and nonclinical sections for IND and NDA/BLA submissions, as well as required minor and major submissions to ensure regulatory compliance.
• Critically review and edit CRO nonclinical toxicology study reports, analyze and interpret data, and coordinate report finalization with the help of nonclinical study monitors.
• Provide critical input on nonclinical pharmacology, and pharmacokinetic programs, protocols, reports, and regulatory content.
• Ensure documentation consistent with global regulatory and compliance requirements.
• Manage and monitor nonclinical studies (GLP and non-GLP) at the CROs per vendor management SOPs and ensure global regulatory/compliance requirements are met/exceeded
• Provide analysis, interpretation, and visualization of nonclinical pharmacology, PK, and toxicology data in preparation for internal department communication and final study reports.
• Leadership and participation on cross functional teams as nonclinical development expert to ensure proper integration of these activities into overall project plans
• Partner with and provide subject matter expertise to key internal constituencies (regulatory, Quality, Clinical, CMC and formulations, Drug safety, Medical affairs) and their external contractors or collaborators.
• Contribute to departmental processes such as SOP's and templates
• Maintain a current understanding of relevant literature and methodology, as well as the scientific literature related to the specific pipeline products and R&D projects

Requirements:
• DVM or Ph.D
in Pharmacology /Toxicology or Biological Sciences required.
• 10-15 years of industry experience in conducting biologics and pharmaceutical research and development
DABT required.
• Experience with both large and small molecules, for oncology and non-oncology disease targets, during early/late stage clinical development and post-marketing.
• Experience in outsourcing, vendor management, and interfacing with internal Finance and legal groups, establishing and managing consultants and CROs driving timely delivery of clear, accurate, and well-written nonclinical study data; as well as real-time communication of unexpected outcomes and mitigation plans.
• Strong knowledge of FDA, EMA, and ICH guidance documents including GLP regulations
• Required experience in authoring regulatory submissions, including full BLA/NDAs or significant sNDAs, as well as multiple INDs and preparing detailed science-based responses to regulatory questions.
• Deep understanding of QA, regulatory, and clinical functions to guide key nonclinical activities, setting up drug candidates for success at all stages of development.
• Working knowledge of CMC, and product quality, to enable impurity assessment and justification of specifications.
• Demonstrated experience in evaluating PK/PD correlations, PK modeling, and parameter estimation a plus.
  • Principals only
    Recruiters, please don't contact this job poster.
  • do NOT contact us with unsolicited services or offers


View map ",San francisco bay area,California"
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Posted on Nov 14, 2017

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