Director, Safety and Mechanistic Pharmacology

1 month ago

Waltham, United States AstraZeneca Full time

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**:

- 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.

**Desirable in the role**:

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

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