Director, Project Toxicologist, BioPharma Safety in Clinical Pharmacology & Safety Sciences (CPSS)

What you will do

As a Director Project Toxicologist BioPharma Safety in Clinical Pharmacology & Safety Sciences (CPSS)at AstraZeneca your main accountabilities will be:

• As a core member of multi-disciplinary BioPharma drug development teams you will design deliver and interpret innovative toxicology strategies to predictassessand mitigate target- andmodality relatedsafety risks.

• Develop and implement innovative solutions to combine regulatory toxicology withground breakingscience 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 andcontributeto regulatory submissions.

• Maintainexpertisein regulatory requirements and preclinical safety approaches applied to Drug Candidates and awareness of industry trends.

• Additionalresponsibilities include to provide experienced nonclinical evaluation of in-licensing and out-licensing opportunities and to provide mentorship and guidance toemergingtoxicologists with respect to the regulatory environment and support their career growth and development in this field.
  

Essential requirements for this role

• A PhD in toxicology cell biology pharmacology systems biology or a related scientific discipline or an advanced university degree accompanied by at least 10 years of relevant professional experience.

• Extensive experience in the pharmaceutical or biotechnology industry working as a non-clinical safety lead supporting cardiovascular renalmetabolicor respiratory programs with planning executioninterpretationand communication of regulatory toxicology data.

• Experience with design of strategies and execution of in vitro and in vivo experiments todeterminethe safety and efficacy of cardiovascular renal and metabolism therapeutics.

• Demonstrates a proven understanding ofend-to-enddrug development witha track recorddelivering toxicology programs from IND throughlate stageclinical development.Late-stageexperience leading or contributing to New Drug Application (NDA) and/or Biologics License Application (BLA) submissions is essential for the role.

• Strong understanding of regulatory guidelines and experience with compilation of toxicology information into regulatory submission documents.

• Exhibits excellent verbal and written communication strong interpersonal effectiveness and the ability to influence stakeholders at all levels; this capability is essential for the role.

• Demonstrates an inclusive collaborative working style that builds trust and shared ownership; combines ahandsondrive to dive into details when needed with a strong commitment to enabling others success consistently acting with an enterprise mindset across teams and functions

• Ability to solve problems in a goal-focused fashion with willingness to challenge conventional thinking and capacity to coordinate tasks across multiple projects.

• Represent AstraZeneca interestsmaintaininghigh ethical and scientific standards.

• Established record of scientific contribution in peer-reviewed journals and scientific symposiums.

• Experience with various modalities such as small molecules siRNAs ASOs peptides andbiologicsfor example.
  

Desirable in the role

• Certifications such as Diplomate of the American Board of Toxicology (DABT) and/or European Registered Toxicologist (ERT) is preferred.
  

The annual base pay (or hourly rate of compensation) for this position ranges from $178540.80 - 267811.20 USD Annual. Our positions offer eligibility for various incentivesan opportunity to receive short-term incentive bonuses equity-based awards for salaried roles and commissions for sales roles.Benefits offered include qualified retirement programs paid time off (i.e. vacation holiday and leaves) as well as health dental and vision coverage in accordance with the terms of the applicable plans.