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Senior Director, Vaccines & Immunity (V&I) Therapeutics Toxicology Strategy

Cambridgeshire, Gaithersburg, Maryland, Waltham, Massachusetts
Full time
Posted
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AstraZeneca UK
Healthcare & medical
10,001+ employees
46 jobs
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Senior Director, Vaccines & Immunity (V&I) Therapeutics Toxicology Strategy- Clinical Pharmacology and Safety Sciences

Gaithersburg, US; Waltham, US; Cambridge, UK

Are you passionate about working for global health care company who truly puts patients first? Would you like to apply your toxicology expertise in a company that is accelerating innovative science and turns ideas into life changing medicines?

AstraZeneca is looking to recruit a talented and experienced Project Toxicologist at the Senior Director career level to provide non-clinical toxicology strategic and scientific leadership versus our exciting Vaccines & Immunity portfolio, specifically supporting COVID, influenza, respiratory syncytial virus (RSV) and bacterial infections, particularly those resistant to current antibiotics via a range of drug modalities and vaccines.

As an empowered Project Toxicologist at AstraZeneca, you will work at the forefront of toxicology and safety science, working in a multidisciplinary and international environment where you will play a key role in progressing our rich and diverse pipeline. The Strategic Toxicology Leader will provide critical insight and judgement to enable successful nonclinical development of V&I projects for the global AstraZeneca portfolio. You will combine your experience in toxicology and drug development with strong communication and interpersonal skills to communicate across all levels of internal and external stakeholders.

This role will report to the head of the Head of Respiratory & Immunology, Neuroscience, Vaccines & Immune Therapies (RINVI) Safety and will be a member of the RINVI Safety department leadership team.

As Strategic Toxicology Lead, your main accountabilities will be:

  • Ensuring the optimal toxicology strategy is delivered to support V&I portfolio clinical development, including first-time in human-enabling, early and late stage development and marketing.
  • Act as project toxicologist leading nonclinical safety aspects of early and late stage projects with in the V&I portfolio including high profile projects such as SARS-CoV-2 mAbs and vaccine.
  • Coach project toxicologists on technical/operational aspects of project toxicology: ensuring line of sight from discovery through to licensure
  • Partner with V&I scientists, Discovery Safety leaders, Safety Innovation and Regulatory Toxicology Safety Pharmacology departments to address potential project safety liabilities and secure peer input vs investigative safety work across the V&I portfolio.
  • Provide High level (regulatory) document review to ensure quality nonclinical summaries and other high-level regulatory documents for internal decision-making bodies and external health authorities
  • Nonclinical safety expert on due diligence teams for vaccine and anti-infective drug candidates
  • Represent CPSS on the V&I Research Board and project teams and present nonclinical safety findings and the relevant mitigation strategies to the leadership team
  • Member of the AstraZeneca R&D Safety Assessment Review Board vs V&I projects
  • RINVI Safety Leadership Team member: identify, set, and deliver on overall department objectives and talent development

Required skills and qualifications include:

  • A PhD education (or equivalent experience) in Toxicology or a related life-science subject, with typically 10-15 years' experience working as a Toxicologist within a pharmaceutical project environment and extensive knowledge and experience of all phases of drug development from early discovery to marketing; from a nonclinical perspective but also with a good understanding of key partners such as Clinical and Regulatory functions
  • Specialist toxicology knowledge and extensive experience of anti-infective therapy development
  • Significant experience in providing expert design and interpretation of toxicology programmes
  • Excellent influencing and project leadership skills
  • Ability to operate with sensitivity and flexibility within an organisational matrix of project and line management, both functionally and across the business
  • Willingness to challenge conventional thinking and implement creative ideas balanced with a high regard and understanding for the regulatory framework in which AstraZeneca operates

Why AstraZeneca

At AstraZeneca, we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

Salary: Competitive

So, what’s next?

Are you already imagining yourself joining us? Good, because we can’t wait to hear from you!

Additional information

Our Company Values & Behaviours underpin everything we do so please take a moment to familiarize yourself with them. You may also want to check out our new R&D Video showing how we turn Science into Medicines.

Date Posted

25-Jul-2022

Closing Date

29-Jul-2022

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.