Senior Manager / AD Development Non-Clinical Safety Leader

SoseiHeptares Cambridge Reino Unido
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Descripción de la Organización

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

Puesto

Pre-clinical Development at Sosei Heptares is seeking an experienced Senior Manager / AD Development Non-clinical Safety (Safety Pharmacology/Toxicology) to act as a Toxicology Project Lead and be responsible for the progression of all aspects of non-clinical safety. You will support the transition of molecules between Discovery and Development.

The position is an exciting opportunity to work at the interface between Pharmacology, Medicinal Chemistry, Translational Sciences, DMPK/PKPD and Development groups to aid in the correct selection of targets, the best compounds for clinical nomination and to progress compounds through clinical development

The successful individual will be empowered to develop and implement safety strategies and studies to bring a quantitative and mechanistic interpretation to the potential safety pharmacology and toxicology risks associated with a broad range of projects and therapeutic areas, working closely with internal colleagues and our external collaborators.

Responsibilities:

The successful candidate will be expected to work independently and:

  • Lead the scientific and operational design, conduct, implementation, and analysis of nonclinical toxicology programmes* to support the progression of Heptares development portfolio into clinical Phase I (* to include general toxicology, safety pharmacology, reproductive toxicology and genetic toxicology).
  • 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.
  • Engage with other Preclinical Development lines, CROs and external experts regarding conduct and interpretation of both regulatory and bespoke non-clinical safety studies.
  • Communicate project status, progress, and potential impediments to the Head of Preclinical Development.
  • Authoring and reviewing of toxicology sections of Regulatory documentation.
  • 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.
  • Maintain awareness and application of Regulatory requirements relating to nonclinical toxicology studies.

Requisitos

The successful candidate is expected to have:

  • PhD would be desirable, but not a requirement given enough years of experience, with at least 5 years working in safety pharmacology or toxicology, ideally with project representative experience.
  • The ideal candidate would have experience in
    • designing in vitro and vivo studies to fit project need
    • running and managing these studies through a network of external collaborators
    • 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

What’s in it for you?

  • State-of-the-art R&D centre located in the heart of the Cambridge science cluster
  • Competitive compensation package including discretionary cash bonuses
  • Eligible for grants of Restricted Stock Units in Sosei Group Corporation
  • 25 days annual leave in addition to public holidays
  • Employer contribution to pension
  • Private Medical Insurance and a cash plan for dental and optical reimbursement
  • Health and wellbeing benefits including a subsidised individual gym membership
  • Income protection to cover long term absences due to ill health
  • Group Death in Service equal to 4x basic annual salary

Why Sosei Heptares?

At Sosei Heptares, we are dedicated to the pursuit of scientific innovation. Our mission is 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.

Working at Sosei Heptares

The Sosei Heptares R&D centre is a modern, state-of-the-art centre located within easy shuttle reach of Cambridge and Whittlesford Parkway train stations. We offer a collaborative, diverse and inclusive working environment that considers your individual needs and believes in maintaining a sustainable work-life balance. You will be welcomed by a team of colleagues with decades of accumulated experience in their areas of expertise, happy to help you develop your own skills in a highly collaborative environment and who are keen to provide guidance and support in your personal and career development plans.

Our Vision and Values

To become one of Japan’s science and technology-led biopharmaceutical drug discovery champions. To achieve this, we will leverage our global know-how and operating agility to deliver a sustainable pipeline of first or best-in-class therapeutics, ensuring our place amongst the next generation of leading innovators.

We are guided by three fundamental values.

  • Limitless Compassion
  • Unswerving passion
  • Continuous self-innovation

These unchanging set of core values that serves as a guide across all our activities

Join Us!

Otra información

The successful candidate will be employed by Heptares Therapeutics Ltd, a UK wholly owned subsidiary of Sosei Group Corporation.

Sosei Heptares is committed to building a diverse and ambitious workforce, and to promoting equal opportunities in employment. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore, all qualified applicants will be considered for employment: we do not discriminate based on age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex, sexual orientation, or any other classification prescribed by law.

Applications should include a CV and covering letter, providing a short description of the background to their interest in the role. Please apply through our on-line job’s portal with your application in pdf format, quoting reference number 2021-Nonclinical-Safety-Dev004 The closing date for applications is 31st May 2022.

Sosei Heptares does not accept speculative or unsolicited CVs from agencies. All speculative or unsolicited CVs submitted without an agreement in place will be considered Sosei Heptares's property and will not obligate us to pay a referral fee.

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