MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a difference in people's lives every day. As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease.
We're constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We're pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines.
And we're industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.
MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.
This is a middle-senior level position within the Biologics Safety Assessment group at MedImmune. The position requires experience in designing, planning, conducting, monitoring, and reporting of nonclinical safety studies.
Significant biologics therapeutic product development experience at a pharmaceutical or biotechnology company is required. Familiarity with GLP regulations and regulatory guidelines for the testing of biopharmaceutical products and experience with compilation of toxicology information into various regulatory submission documents is required. Excellent communication skills are required. Toxicologists within the BSA group serve as Toxicology Project Leaders (TPLs). TPLs are key members of Research and Development teams, contribute to the creation of overall drug development plans, and are accountable for the delivery of the preclinical safety assessment component of these plans, ensuring appropriate strategies and toxicological interpretations are provided to meet business objectives.
Major Duties and Responsibilities (including supervising others):
The Principal Toxicologist will serve as a TPL for the design, conduct, and reporting of nonclinical safety studies. Acts as Study Director, Study Monitor and/or Principal Investigator for nonclinical safety studies conducted in-house and at contract facilities.
Contributes to, prepares, and/or reviews regulatory documents (CTAs, IMPDs, INDs, BLAs, etc) and interacts with regulatory authorities as needed. Communicates toxicology data to project teams and ensures delivery of the preceding in line with the business objectives of validity, integrity, quality, timing and cost. Provides budgeting and forecasting information to management.
Identifies threats to the preclinical safety assessment plan, and proposes options for resolution or mitigation. Maintains immunological and toxicological expertise relevant to nonclinical safety of biologics; this includes, but is not restricted to, keeping up to date with the scientific literature, attending and contributing to relevant international meetings, and publishing in peer reviewed journals if appropriate. Provides risk assessment for novel targets within multiple disease areas. Represents MedImmune within the AZ group of companies and externally.
Ph.D. in Toxicology or Biomedical Sciences (e.g., immunology or pharmacology)
7-10 years post-Ph.D. experience, including 5 years in biopharmaceutical industry research.
Hands on and project management related experience in preclinical safety of biologics and vaccines.
Ability to interact successfully in a cross-functional team setting.
Understanding of CRO functions and how to work with CROs. Experience working with common toxicological species, including primates. Understanding of toxicological mechanisms as the basis for developing safe medicines.
Understanding of the regulatory requirements for the toxicology testing of biologics. Understanding of the drug development process. Basic understanding of immunology.
Basic understanding of pharmacokinetics and PK/PD relationships, in particular in relation to biologics. Basic understanding of CMC for biologics. Knowledge of the mechanistic basis of disease processes in humans. Knowledge of medical terminology.
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AstraZeneca is an equal opportunity employer.
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