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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
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"
Expire: Feb 12, 2018
Posted on Nov 14, 2017

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