Director, Project Toxicologist, BioPharma Safety

Göteborg
Tillfälligt
Heltid

6 timmar sedan

Om jobbet:At AstraZeneca, it is our bold ambition to achieve disease modification, clinical remission, and cure, to impact the lives of millions of people worldwide suffering from cardiovascular, renal, metabolic and respiratory diseases. We are now expanding our diverse pipeline to secure leadership in numerous BioPharma indications.We are looking for a motivated and passionate individual to join us as a Director, Project Toxicologist, BioPharma Safety with a focus on enabling the delivery of transformative and safe drugs to patients. You will provide non-clinical safety expertise for our diverse discovery portfolio containing a broad range of drug modalities. This high-impact role supports the advancement of the BioPharma pipeline by designing, planning and interpreting toxicology studies, assessing safety risks, and contributing to project strategy. 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 in Gaithersburg (MD), Waltham (MA), Boston (MA), Gothenburg (SE), Cambridge (UK).What you will doAs a Director, Project Toxicologist 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, 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 contribute to regulatory submissions.Maintain expertise in regulatory requirements and preclinical safety approaches applied to Drug Candidates and awareness of industry trends.Additional responsibilities include to provide 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 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, renal, metabolic or respiratory programs with planning, execution, interpretation and communication of regulatory toxicology data.
*Experience with design of strategies and execution of in vitro and in vivo experiments to determine the safety and efficacy of cardiovascular, renal, and metabolism therapeutics.
*A proven understanding of drug development and a track record of delivering multiple toxicology programs from IND through late-stage clinical development.
*New Drug Applications (NDA) or Biologics License Applications (BLA) submissions experience is preferred.
*Strong understanding of regulatory guidelines and experience with compilation of toxicology information into regulatory submission documents.
*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. Represent AstraZeneca interests, maintaining high ethical and scientific standards.
*Established record of scientific contribution in peer-reviewed journals and scientific symposiums.Desirable in the role*Experience with various modalities, such as small molecules, siRNAs, ASOs, peptides, and biologics.
*In addition to possessing scientific competence, we value individuals who can contribute to our inclusive, positive, and collaborative working environment.
*Certifications such as Diplomate of the American Board of Toxicology (DABT) and/or European Registered Toxicologist (ERT) is preferred.Are you ready to bring your expertise in non-clinical safety to our mission of improving patients' lives?We welcome your application and look forward to learning more about what you can bring to AstraZeneca BioPharma Safety. Please note applications must include your CV and a cover letter which presents you and your key areas of strength / development and why you should be considered for the role (Please make sure to combine your cover letter and CV into a single document, as the system only allows you to upload one file). Submit your application no later than September 22nd, 2025.

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