Associate Director, Non-Clinical Safety

SoseiHeptares Cambridge United Kingdom Biotech

Company Description

Sosei Heptares is an international biopharmaceutical company with a mission to make a significant contribution to improving the quality of life and health of people around the world. To achieve this, we will discover, design, and develop the most innovative and effective medicines for patients worldwide, through our world-leading patent-protected technology and platform.

Our core focus is on the discovery and early development of new medicines originating from our proprietary G Protein-Coupled Receptor (GPCR) targeted StaR® technology and Structure Based Drug Design (SBDD) platform capabilities. Today, we are advancing a broad and deep pipeline of novel medicines across multiple therapeutic areas, including neurology, immunology, gastroenterology, and inflammation diseases.

We have established partnerships with some of the world’s leading pharmaceutical companies and multiple emerging technology companies, including AbbVie, AstraZeneca, Biohaven, Genentech (Roche), GSK, Neurocrine Biosciences, Novartis, Pfizer, Takeda and Verily.

Sosei Heptares is headquartered in Tokyo, Japan with corporate and R&D facilities in London and Cambridge, UK. We have approximately 170 employees based at our state-of-the-art R&D research centre at Granta Park, Cambridge. The size of our company ensures optimum agility and transparent linkage between all activities from early discovery through to clinical development.

For more information, please visit https://soseiheptares.com/. LinkedIn: @soseiheptaresco | Twitter: @soseiheptaresco | YouTube: @soseiheptaresco


Position

Provide scientific design, operational delivery and interpretation of toxicology studies required for Heptares development candidates derived from either internal drug discovery or by in-licensing.

Provide expert understanding of evolving methodologies in the assessment of drug toxicity and their application to development.

Reports to: Head, Preclinical Development

Key Responsibilities:

To act as a Nonclinical Safety/Toxicology Project representative to lead the scientific and operational design, conduct, implementation, and analysis of nonclinical toxicology programmes including general toxicology, safety pharmacology, reproductive toxicology and genetic toxicology, to support the progression of Heptares programs into clinical Phase I, II and beyond to NDA.

Develop and apply detailed understanding of issues in determining the safety impacts of compounds with novel pharmacology.

Engage with project teams and pharmacology to assist the prediction, interpretation and impact of PKPD modelling, toxicology findings, arising in nonclinical toxicology studies.

Work with Discovery to build the project appropriate screening cascade for the detection of possible safety risks of potential discovery candidates. Advise on, or manage, specific follow up studies.

Engage with other Preclinical Development lines, CROs and external experts regarding conduct and interpretation of both regulatory and bespoke nonclinical safety studies.

Ensure CROs are identified, selected and proactively managed, including GLP compliance, to meet the company’s objectives.

Communicate project status, progress, and potential impediments to the Head, Preclinical Development

Authoring and reviewing of toxicology sections of Regulatory documentation.

Pre-candidate selection: play an active role (within project teams) in the candidate selection

phase of lead optimisation projects to ensure the best molecules are selected for clinical

development.

Maintain awareness and application of Regulatory requirements relating to nonclinical

toxicology studies.

Develop realistic budgets for the toxicology element of development programmes to achieve the required project plan.

Work closely with and get expert input from scientists within Sosei Heptares to meet the company’s objectives.

Work closely with Clinical Project Leaders to assess progress against plans and budget.

Requirements

  • PhD would be desirable, but not a requirement given sufficient years of experience, with at least 5 years working in safety pharmacology or toxicology, ideally with significant project representative experience.
  • The ideal candidate would have experience in
  • designing Nonclinical Safety strategy for projects from compound nomination to Phase 1
  • designing in vitro and vivo studies to fit project need
  • running and managing these studies through a network of external collaborators/CROs
  • interpreting and integrating the returning data to report back to project with recommendations.
  • Excellent understanding of drug development, regulatory principles and clinical development requirements including GLP and 3Rs.
  • An excellent project manager, with ability to multitask through management of multiple projects at a time, with ability to prioritise.
  • Experience in writing regulatory documentation and answering regulatory questions


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