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Lieu: Cambridge, Angleterre, Royaume-Uni
ID de l'offre 13375795
Date de publication: 09/18/2019

Associate Director/Director Translational Medicine - Neuroscience

Location(s) – Cambridge (UK)

Salary - Competitive salary and company benefits apply

Are you passionate about joining a company that truly puts patients first? We would love to hear from you if you are keen to hear more about an opportunity in our Neuroscience group.

At AstraZeneca, every one of our employees makes a difference to patient lives every single day. We are building on our strong pipeline and turning ideas into life-changing medicines that benefit patients around the globe.

The new BioPharmaceuticals R&D organisation brings together research and development teams, from discovery through to late-stage development for Cardiovascular, Renal & Metabolic (CVRM), Respiratory, Inflammatory and Autoimmune (RIA) therapy areas, and opportunistically for Microbial Sciences and Neuroscience.

Role

You will play a key role in translating preclinical knowledge to impact early clinical development of novel molecules to treat chronic pain and neurodegenerative diseases.

We will need you to contribute clinical insights and disease understanding to the selection and evaluation of targets. An understanding of translational approaches as they pertain to clinical trial design and regulatory process, proof-of-concept studies, and identification and implementation of biomarkers and diagnostics is required.

The individual will help design, execute and analyse translational biomarker studies to support clinical development, with an emphasis on proof of mechanism (PoM) and identification of patients likely to respond to the agent under development.

You have a strong background in research and early clinical development of therapeutics, biomarker assay development and execution in clinical settings, PK/PD and regulatory standards.

You’ll be part of a team that pulls together to put patients first.

Responsibilities

Reporting to the Head of Translational Medicine, you will have the following duties:

  • Working alongside Research Biology and Clinical Development, lead effort to develop an overall translational (biomarker) strategy to support rapid progression of molecules into early clinical development to demonstrate PoM (target engagement) and clinical PoC.
  • Working with Research Biology, Clinical Development and external organisations, contribute to the design and conduct of disease linkage studies and methodology studies to support clinical indications, selection of patient population and biomarker development to impact early clinical trials.
  • Working within a matrix environment, help develop appropriate in vivo translational pharmacology models pertinent to the Neuroscience portfolio that will demonstrate target engagement and build a relationship between dose, schedule, PK, and pharmacodynamics (with translational biomarkers).
  • Working alongside DMPK and Clinical Pharmacology groups, ensure quantitative PK/PD methods are applied to enable translation from preclinical research to clinical development, including dose selection in clinical trials.
  • Working closely with Statistics, Clinical Pharmacology and Clinical Development, propose and develop quantitative clinical decision criteria and optimal trial design operating characteristics.
  • Serve as key point person to oversee early activities for successful translation of preclinical research to clinical settings to establish PoM and PoC.
  • Identify, develop and qualify biomarker analytical methods through collaboration with internal laboratories or CROs, including laboratory oversight and project management.
  • Provide input on biological sampling and biomarker assays in pre-clinical and clinical protocols, Investigator’s Brochure and regulatory documents.
  • Set up and manage collaborations with academia, public-private partnerships and CROs to ensure project translational objectives are met.
  • Lead translational working groups to address specific translational biomarker development challenges.

Requirements

You will possess extensive industry experience in R&D of novel therapeutics. A proven track record in Translational and Clinical Research in drug development is required.

And you will be M.D/PhD educated in pharmacology, clinical pharmacology, pharmaceutical science or biological sciences. Neuroscience training and experience in academia or industry, particularly in chronic pain or neurodegeneration is desirable.

Other skills needed for the role are:

  • Strong leadership and interpersonal skills are needed for this role, to work and lead in a matrix team environment
  • Excellent verbal and written communication skills.
  • Organisational skills with attention to detail, as well as a proven ability to write technical reports, biomarker protocols, perform quantitative analyses and graph and present data.
  • Experience in both preclinical, laboratory-based, research and clinical development
  • Hands-on experience in development of in vitro and in vivo assays for research and clinical use, with the aim of assessing biomarkers for PoM and patient selection.
  • Strong knowledge of research and clinical development of biologic and small molecule therapeutics. Experience with other modalities e.g. PROTACs, siRNA, gene editing would be desirable.
  • Familiarity with predictive biomarkers and personalized medicine approaches as they pertain to research and early clinical development
  • Familiarity with clinical protocols and regulatory processes.
  • Proven record in successful management/steering of external collaborations (academic, CRO, public-private consortia)

Next Steps – Apply today

We feel that we are a great place to work, coupled with an industry-leading portfolio of products that make AstraZeneca an employer of choice.

Director, Translational Medicine - Neuroscience
Domaines scientifiques

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