Senior Principal Scientist- General Toxicology Study Director
Posted on Apr 6, 2021 by Pfizer
Pfizers Drug Safety R&D (DSRD) is a global organization that provides input into drug target selection, helps identify promising drug candidates, discovers and develops biomarker and screening assays, and leads the conduct and interpretation of toxicology studies in support of clinical development programs and registration. Within DSRD, Global Toxicology executes general and specialized toxicology study strategies to aid in compound selection and enable clinical development across all phases for all therapeutic areas and modalities, derisk and manage issues, and communicate key information to support decision making in the drug development process. The General Toxicology Senior Principal Scientist- Study Director is responsible for the design, conduct, interpretation, and reporting of exploratory, mechanistic and GLP in vivo toxicology studies, either conducted internally or by managing the conduct of studies externally. This role will also serve as liaison from General Toxicology to therapeutic area leadership teams and/or serve on multidisciplinary project teams.
The successful candidate will be recognized as a collaborative scientist and subject matter expert who will apply advanced and comprehensive scientific knowledge and prior work experience to design and execute experiments, participate in and/or lead interdepartmental projects, and engage with external professional societies and consortia. This individual will identify, develop, and lead scientific strategies to support group goals and set direction for the group. The candidate is expected to work independently using their own ideas, knowledge, and experience to routinely develop hypotheses and investigate/solve complex problems, promote the use of novel approaches, and apply business acumen and high level of scientific judgement to make decisions and achieve alignment with stakeholder/interdepartmental needs.
Responsibilities- Study Director
Responsible for overall technical conduct of in vivo toxicology studies, as well as for the overall interpretation of the studies as described in 21 CFR 58.33., while ensuring compliance with applicable SOPs and guidelines, and Animal Use Protocols.
Responsible for communicating with Drug Safety Team Leads (DSTL) to understand study design, including variation from standardized protocol outlines.
Decision-making responsibilities include:
Final call on interpretation of study findings including overall study conclusion
Major modification to study design (eg, discontinuation, dose changes, etc.)
Handling study deviations and amendments
Responsible for dose selection in conjunction with the DSTL
Other responsibilities may include serving as a portfolio liaison for Global Toxicology to Therapeutic Area Leadership Teams, serving as a DSTL, participating in or leading cross-site teams or consortia, acting as Principal Investigator for animal use protocols, developing new models and methods, authoring guidelines, formal or informal mentoring of junior colleagues, and/or data collection systems updates and implementation processes.
Responsibilities Associated with External Studies
Responsible for oversight of all phases of outsourced studies (study enabling, study setup, in-life, and reporting)
Responsible for partnering with DSTLs and subject matter experts to ensure study milestones are appropriately timed and meet necessary scientific and regulatory requirements
Responsible for participating in on-site monitoring of study activities at CRO sites and CRO qualifications as needed
Provides input/feedback to General Toxicology Study Management group, Outsourcing Operations, and CRO staff on issue resolution, best practices and opportunities for improving activities and relationships
PhD in toxicology, pharmacology, or other appropriate discipline with 8 years relevant professional experience OR
MS with at least 10 years pharmaceutical industry experience in the design, conduct, direction, or monitoring of toxicology studies.
Prior pharmaceutical industry experience developing and executing drug safety strategies to advance therapeutic drug candidates
Familiarity working under GLP regulations
Experience working in or leading multidisciplinary teams
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