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

AstraZeneca
Full-time
On-site
Gothenburg

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, 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 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 individual contributor you will provide non-clinical safety expertise for our diverse portfolio containing a broad range of drug modalities. This high-impact development role supports the advancement of the BioPharma pipeline by designing, planning and 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 in Gaithersburg (MD), Waltham (MA), Boston (MA), Gothenburg (SE), Cambridge (UK). (3 days onsite per week) 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 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. Demonstrates a proven understanding of end-to-end drug development with a track record delivering toxicology programs from IND through late stage clinical development. Late-stage experience 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 a handson drive 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 interests, maintaining high 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, and biologics for 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 $178,540.80 - 267,811.20 USD Annual. Our positions offer eligibility for various incentives—an 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. Date Posted 17-Dec-2025 Closing Date 06-Jan-2026 Our 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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.