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Director – Project Toxicologist – Immune Oncology safety

Director – Project Toxicologist – Immune Oncology safety

CompanyAstraZeneca
LocationCambridge, UK, Gaithersburg, MD, USA
Salary$Not Provided – $Not Provided
TypeFull-Time
DegreesPhD
Experience LevelSenior, Expert or higher

Requirements

  • DABT or PhD in toxicology, immunology, or immunopharmacology with several years of experience in the pharmaceutical or biotechnology industry working as a non-clinical safety lead, supporting immune-Oncology programs with planning, execution, interpretation and communication of regulatory toxicology data.
  • A proven understanding of drug development and a track record of delivering multiple toxicology programs to IND and through clinical development.
  • High level of knowledge and expertise in designing toxicology strategies and delivering in vitro/in vivo and risk assessment of immune related risks / adverse events, driven by mechanism and/or TCE.
  • Expertise in immunology or oncology, including T-cell biology.
  • Ability to solve problems in a goal-focused fashion with willingness to challenge conventional thinking and capacity to coordinate tasks across multiple projects.
  • Excellent verbal and written communication-, interpersonal- and influencing skills. Adopting an inclusive and collegiate working style, and a desire to drive own- and support others development.

Responsibilities

  • As a core member of multi-disciplinary oncology drug development teams, you will design, deliver, and interpret innovative toxicology strategies to predict, assess and mitigate target- and modality related safety risks.
  • Develop and implement innovative solutions to combine regulatory toxicology with ground-breaking science and technologies to progress novel drug candidates to the clinic and through development to the market, in line with business needs.
  • To influence project strategy and decision making, you will communicate clear positions on integrated risk assessments in various formats including informing internal decision-making governance bodies and interacting with external health authorities.
  • Delivering quality nonclinical summaries and other high-level regulatory documents for internal decision bodies and external health authorities.
  • Maintain expertise in regulatory requirements and preclinical safety approaches applied to Drug Candidates and awareness of industry trends.
  • Additional responsibilities include providing experienced nonclinical evaluation of in-licensing and out-licensing opportunities and to provide mentorship and guidance to emerging toxicologists with respect to the regulatory environment and support their career growth and development in Immune oncology department.

Preferred Qualifications

  • Experience with TCE and other large molecules will be desirable.
  • In addition to possessing scientific competence, we value individuals who can contribute to our inclusive, positive, and collaborative working environment.
  • DABT is considered an advantage.