Director, Safety and Mechanistic Pharmacology

Waltham, Massachusetts
Full time
Posted
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AstraZeneca
Science & biotechnology
10,001+ employees
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Are you an expert within Safety Pharmacology with extensive knowledge in designing and interpreting high quality studies, translating scientific findings into applicable information in a drug development environment? Be part of a dedicated Research & Development team. Fuelled by our commitment to help more patients, strengthen our pipeline and grow our area.

To help deliver our growing portfolio, we are currently seeking an experienced Safety Pharmacologist to join the Safety & Mechanistic Pharmacology team at AstraZeneca as a Director, Safety and Mechanistic Pharmacology.

The Regulatory Toxicology and Safety Pharmacology team sits within CPSS and plays a central role in progressing a rich and diverse pipeline comprising many different modalities across all of our therapeutic areas. We work collaboratively to deliver safety science from early discovery through clinical development, with emphasis on the science and studies required to enable the clinical development of new medicines. Clinical Pharmacology & Safety Sciences (CPSS) is a multi-faceted department which underpins AstraZeneca's Biopharmaceutical and Oncology Portfolio from target selection through to Life-cycle management.

What you will do:

In this role you will apply your extensive drug discovery expertise to support the progression of a progression of a broad portfolio of drug projects. You'll be responsible for authoring Safety Pharmacology sections of submission documents, engaging with and responding to Health Authority questions and contributing to the labelling of new products. Earlier in the drug discovery pipeline, you will be designing and interpreting safety pharmacology studies enabling first time in human submissions as well as investigative work at all stages. This will involve close collaboration with a wide range of experts in a highly matrixed environment across the development chain, for multiple project safety teams in parallel. You'll be working with many different modalities beyond classical biopharmaceuticals, so you'll need to be creative and work in areas where there are no pre-defined solutions, utilising the best capabilities within and outside AstraZeneca.

In this role you will use your extensive drug discovery expertise to set the overall Safety Pharmacology strategy for the Cardiovascular, Renal and Metabolic (CVRM) portfolio, and applying this to enable the progression of a broad range of drug projects. To achieve this you'll work closely with multiple project safety teams, collaborating with a wide range of experts in a highly matrixed environment across the development chain. You'll be responsible for designing and interpreting safety pharmacology studies enabling first time in human submissions as well as investigative work at all stages. You'll be working with many different modalities beyond classical biopharmaceuticals, so you'll need to be creative and work in areas where there are no pre-defined solutions, utilising the best capabilities within and outside AstraZeneca.


Your main tasks will include:

  • Design and interpret fit for purpose safety pharmacology packages and guide projects with tangible, quantitative risk assessments that underpin science-driven decisions.
  • Develop patient-centric safety pharmacology risk assessment strategies applicable to novel therapeutic modalities, where conventional approaches may not be appropriate or possible.
  • Author non-clinical safety pharmacology sections of regulatory submission documents and engage with regulatory authorities to secure approval of IMPD/IND and MAA/NDA submissions.
  • Extend the Safety Pharmacology beyond the boundaries defined by ICH S7A and S7B and shape the discipline externally with publications, collaborations and involvement in consortia.

Essential in the role:

  • Extensive experience in pharmaceutical development, with a PhD (or equivalent experience) in pharmacology, toxicology, pathology or a related Natural Science field.
  • Experience of Safety Pharmacology in drug discovery and development, with exposure to non-clinical safety assessment in a project setting.
  • Experience with nonclinical regulatory submissions and health authority interactions
  • Demonstrable expertise in the design and interpretation of in vitro and in vivo studies, translating scientific findings into applicable information in a drug development environment.
  • Familiarity with pharmacokinetic-pharmacodynamic and systems pharmacology approaches.
  • Validated ability to run a large portfolio of projects including prioritize activities in a matrix environment.
  • Understanding of the external factors that shape the scientific and regulatory landscapes relevant to Safety Pharmacology.
  • Proven strong scientific track record and problem-solving capabilities.


We also believe that the successful candidate should have high ability to communicate and present your work in a natural and clear way and enjoy working across multi-disciplinary teams with efficiency.

Desirable in the role:

  • In depth knowledge of cardiac function, ECG and imaging modalities.
  • Diplomat of Safety Pharmacology, DABT or ERT accreditation.