Director, Project Toxicologist, BioPharma Safety in Clinical Pharmacology

Job Title: Director, Project Toxicologist, BioPharma Safety in Clinical Pharmacology & Safety Sciences (CPSS)Location: Gaithersburg (MD), Waltham (MA), Boston (MA), Gothenburg (SE), Cambridge (UK).At AstraZeneca, it is our bold ambition to achieve disease modification, clinical remission, and cure, toimpactthe lives of millions of people worldwide suffering from cardiovascular, renal,metabolicand respiratory diseases. We are now expanding our diverse pipeline to secure leadership innumerousBioPharma indications.  We are looking for a motivated and passionate individual to join us as a Director, Project Toxicologist, BioPharma Safety in Clinical Pharmacology & Safety Sciences (CPSS) with a focus on enabling the delivery of transformative and safe drugs to patients. This is a Senior Project Toxicology position. As an individualcontributoryou will provide non-clinical safetyexpertisefor our diverse portfoliocontaininga broad range of drug modalities. This high-impact development role supports the advancement of the BioPharma pipeline by designing,planningand interpreting toxicology studies, assessing safety risks, and contributing to project strategy supporting all phases of clinical development. The position is based in a collaborative, multidisciplinary environment within the Clinical Pharmacology and Safety Sciences function. The position will be based at one of our vibrant strategic R&D sites inGaithersburg (MD), Waltham (MA), Boston (MA), Gothenburg (SE), Cambridge (UK). (3 days onsite per week) What you will doAs 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 predict,assessand 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 roleA 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, renal,metabolicor respiratory programs with planning, execution,interpretationand 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 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 functionsAbility to solve problems in a goal-focused fashion with willingness to challenge conventional thinking and capacity to coordinate tasks across multiple projects.Represent AstraZeneca interests,maintaininghigh 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 roleCertifications such as Diplomate of the American Board of Toxicology (DABT) and/or European Registered Toxicologist (ERT) is preferred.Date Posted17-Dec-2025Closing Date06-Jan-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.