Search
Zip code

Biotech, R&D, & science

Sponsored Links

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
Ads has expired
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"
Ads has expired
Posted on Nov 14, 2017

Here are some similar ads

Microbiologist - PhD (Modesto, CA) - Biotech, R&D, & science - Los angeles
Price: contact | USA, California, Los angeles, | Posted on Feb 24, 2018
IEH Laboratories and Consulting Group is accepting applications for PhD - Microbiologist position in its facility in Modesto, CA.Minimum requirement - Ph Din Microbiology RequiredExperience in Food Microbiology preferredTo apply for this position please access the com
Quality Assurance Q.A. Lab Technician (Chino, CA) - Biotech, R&D, & science - Los angeles
Price: contact | USA, California, Los angeles, | Posted on Feb 24, 2018
Specialty Enzymes and Biotechnologies is a rapidly growing enzyme manufacturer and distributor to a wide range of industries throughout the worldWe are currently recruiting for a QA Lab Tech to perform Quality Assurance testing and analysis of enzyme products and raw
Quality Assurance Q.A. Supervisor (Chino) - Biotech, R&D, & science - Los angeles
Price: contact | USA, California, Los angeles, | Posted on Feb 24, 2018
Specialty Enzymes and Biotechnologies is recruiting for a Q.ASupervisor.This position supervises and performs Quality Assurance testing and analysis of commercial enzyme products and rawmaterialsEnsures GMP requirements are met for Quality Assurance operations.Maintai
FDA Compliance Researcher Bilingual, Japanese/English - Biotech, R&D, & science - Los angeles
$35 | USA, California, Los angeles, | Posted on Feb 24, 2018
FDA Consulting company is seeking a Compliance ResearcherBilingual, Japanese/ English a mustMust have at least a Bachelor's Degree in Science fields: Biology, Chemistry, Engineering, Medical, Biochemical, Pharmaceutical, etcGlobizz Corpis one of the first Japanese-Eng
Document Specialist (Clinical Operations) - Biotech, R&D, & science - Los angeles
Price: contact | USA, California, Los angeles, | Posted on Feb 24, 2018
THIS IS ON-SITE, NO REMOTE OR TELECOMMUTEOur growing biotechnology client has experienced tremendous success with their oncology clinical trials and needs a Document Specialist for a long term contractYou will be responsible for assisting the Clinical Operations team
Analytical Chemist GC - Biotech, R&D, & science - Los angeles
Price: contact | USA, California, Los angeles, | Posted on Feb 24, 2018
Analytical chemist - Gas Chromatography American Analytics Inc., (www.americananalytics.com) is an established environmental analytical laboratory, in business for over 30 years, located in Chatsworth (north Los Angeles), California, 91311As result of our current grow
Analytical Chemist (Long Beach, CA) - Biotech, R&D, & science - Los angeles
$25 | USA, California, Los angeles, | Posted on Feb 24, 2018
BelCosta Labs, a 3rd party analytical testing lab, is looking for a full-time analytical chemist.ESSENTIAL FUNCTIONS AND RESPONSIBILITIES-Using and Maintaining the following equipment: HPLC-DAD, GC-FID, LC/MS, ICP-MS -Experience with Method Validation according to ICH
Medical Training Event Steward - Part Time - CA (Long Beach) - Biotech, R&D, & science - Los angeles
$16 | USA, California, Los angeles, | Posted on Feb 24, 2018
Job DescriptionThe Medical Training Event Steward position is a great opportunity to network with physicians and representatives from the medical device and the biomedical engineering industryPosition has high level of exposure to surgical procedures and cutting edge
Anatomical Assistant Laboratory Technician - CA (Long Beach) - Biotech, R&D, & science - Los angeles
$16 | USA, California, Los angeles, | Posted on Feb 24, 2018
Job DescriptionAnatomical Laboratory Technician will participate as a productive team member to execute Science Care policies, procedures, job duties, standards, quality, and metrics within the human tissue recovery laboratory.The technician will report to the Laborat
Sponsored Links
Sponsored Links

Categories

Sponsored Links