Senior Director - Strategic Safety / Toxicology Leader (Oncology) - Clinical Pharmacology and Safety Sciences
AstraZeneca

Job Info

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Senior Director - Strategic Safety / Toxicology Leader (Oncology) - Clinical Pharmacology and Safety Sciences

Location: Gaithersburg MD or Waltham, MA

Are you passionate about applying your skills and expertise to turn ideas into life changing medicines?

AstraZeneca is looking to recruit a Senior Director, Strategic Safety / Toxicology Leader, in Oncology Safety, to provide strategic and scientific non-clinical toxicology leadership versus our exciting Oncology portfolio, specifically supporting Immune-Oncology programs.

The Oncology Safety department, part of the Global Safety Sciences organization, consists of diverse and international teams based across sites in UK, US and Sweden, and delivers drug discovery safety, regulatory toxicology and investigative safety science to discover and develop safe and efficacious innovative treatments for patients. This position is preferably based in Gaithersburg, MD (Washington DC metro area) or in Waltham, MA (Boston metro area).

As an empowered Strategic Safety / Toxicology Leader at AstraZeneca, you will work at the forefront of toxicology and safety science, operating in a multidisciplinary, diverse and international environment. You will play a key role in progressing our rich Oncology R&D pipeline. The Strategic Safety / Toxicology Leader will provide critical insight and judgement to enable successful non-clinical development of oncology projects for the AstraZeneca portfolio, with a focus on Immune-Oncology. You will combine your experience in toxicology, drug safety and drug development with strong leadership, communication and interpersonal skills to communicate across all levels of internal and external stakeholders.

This role will report to the Global Head of Oncology Safety and will be a member of the Oncology Safety department leadership team.

As Strategic Safety / Toxicology Leader, your main accountabilities will be:

• Ensuring the optimal toxicology strategy is delivered to support the Oncology R&D portfolio, enabling clinical development, including first-time in human, early and late-stage development and marketing.
  
• Coach project toxicologists on technical/operational aspects of project toxicology: ensuring line of sight from discovery through to licensure.
  
• Partner with Discovery Safety leaders, Safety Innovation and Regulatory Toxicology Safety Pharmacology departments to secure peer input on investigative safety work across the entire portfolio.
  
• Critical review of Oncology Safety data and communications, prior to key governance presentations and health authority interactions.
  
• Ensure quality of non-clinical summaries of high-level regulatory documents for internal decision-making bodies and external health authorities.
  
• Take accountability for non-clinical safety strategies and decisions, e.g. as a voting member of non-clinical safety review board or active contributor to Oncology portfolio governance on relevant topics.
  
• As a member of the Oncology Safety Leadership Team, identify, set, and deliver on overall department objectives, to support our strategy to Deliver growth and TA leadership, Accelerate innovative science and Be a great place to work.
  
• Engage with key internal and external stakeholders anticipating scientific and portfolio trends to ensure adequate resourcing (e.g. budget forecasting) and capability development.
  
• Proactively contribute to our inclusive culture and provide the right support/challenge balance to enable engaged colleagues to develop their skills and deliver on theirp objectives.
  
  Required skills and qualifications include:
  
• A strong scientific track record, with a PhD in a relevant life-science (e.g. Toxicology, Biology, Pharmacology, Pharmaceutical Science), or equivalent experience.
  
• Specialist knowledge of and extensive experience within the Oncology Immunotherapy field, ideally with a focus on immune related adverse drug reactions.
  
• Extensive Drug Safety / Toxicology experience within a pharmaceutical R&D environment (Pharma, biotech, CRO) and deep knowledge and experience of all phases of drug development from discovery to marketing, from a non-clinical perspective but also with good understanding of key partners such as Clinical and Regulatory functions.
  
• Significant experience in providing expert design and interpretation of toxicology programs, ideally across modalities engaging with the immune system (e.g. checkpoint inhibitors, T cell engagers, CAR T cells).
  
• Excellent influencing, project leadership and communication skills.
  
• Ability to operate with sensitivity and flexibility within an ever-evolving organizational 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.
  
• An inclusive leadership and collegiate working style that contributes to our Great Place to Work objectives.
  
  

Benefits:

AstraZeneca is a leading company in the healthcare industry, with a mission to enrich the lives of others. It's our business to support healthy living, not only for our patients, but also for our employees. Our benefits program is flexible enough to meet employees' varying needs, offers valuable choices, and is highly competitive.

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together.

Come and join our journey - Apply today!

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

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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.

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