Clinical Associate Director - Clinical Operations

SoseiHeptares Great Abington United Kingdom Biotech

Company Description

Sosei Heptares (the corporate brand of Sosei Group Corporation) is a research-focused biotechnology group, publicly listed in Japan (TSE: 4565) and with sites in Tokyo, London and Cambridge (UK).

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.

Our primary focus is 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. The company is advancing a broad and deep pipeline of novel medicines across multiple therapeutic areas, including CNS, immuno-oncology, gastroenterology, inflammation and other rare/specialty indications.

Our Company has established partnerships with some of the world’s leading pharmaceutical companies, including AbbVie, AstraZeneca, Biohaven, Genentech (Roche), GSK, Novartis, Pfizer and Takeda and additionally with multiple emerging technology companies. Sosei Heptares is headquartered in Tokyo, Japan with corporate and R&D facilities in Cambridge, UK.

Sosei Heptares has approximately 170 employees based at its new R&D research facility at Granta Park. The size of the company ensures a transparent linkage between all activities from early discovery through to clinical development.

Position

Provide oversight in the design, set-up, execution and analysis of one or more clinical studies and input to other aspects of clinical operations activities as needed working with other members of the programme development team.

Works principally on Phase I, Phase Ib type studies and may also support Phase II studies.

Reports to: Head of Clinical Operations

Key responsibilities

  • Work with the Clinical/Programme Director/VP Clin. Dev., specialist development project team members and stakeholders to ensure full scientific and operational input into protocol design
  • Develop protocol synopsis and full study protocol
  • Contribute to vendor selection process for CRO
  • Contribute to regulatory authority application and updates
  • Ensure effective and appropriate data collection/management and where appropriate contribute to analysis and interpretation of data
  • Drive and contribute to preparation of the study report
  • Working with Clinical administrators ensure the collection and preparation of an inspection ready Trial Master File
  • Ensure all contractual processes with CRO and insurers in place and implemented according to contract
  • Engage and work with specialist CRO providers to support Phase 1 studies as required (e.g. Pharmacovigilance, clinical monitoring).
  • Operate to Heptares SOPs
  • Contribute ideas to evolve optimal (best practice) approaches within the development and clinical operations groups.

Requirements

Core Skills Required

  • Average 5 years plus experience (with minimum of 3 years) with proven successful track record in the design, conduct and execution of Phase I studies either within a company or a CRO.(Ideally with Phase II experience also).
  • Understanding of drug development and discovery through participation in either preclinical discovery, preclinical development or clinical development
  • Scientific expertise in a development related discipline such as Pharmacology, DMPK, Biopharmaceutics, Toxicology, Clinical Science of a disease area, Clinical Investigation
  • Experience working with CROs to design and execute clinical studies
  • Experience in regulatory and ethical applications, review and approval of clinical studies
  • Good understanding of GCP

Required personal skills

  • Scientific understanding
  • Attention to detail
  • Ability to work in teams
  • Proactive in identifying issues
  • Constructive and creative in developing solutions
  • Timely in responding with sense of urgency

This is an evolving role and the above list of responsibilities is not exhaustive; the postholder may be requested to assume additional duties, as might reasonably be required.

Other information

We offer a competitive salary and benefits package commensurate with qualifications and experience.

Heptares is an equal opportunities employer.

Applications should include a covering letter, providing a short description of the background to their interest in the role, with curriculum vitae including the names and contact details for two referees. Please apply through our on-line jobs portal with your application in pdf format, quoting reference number Dev002. The closing date for applications is 23rd May 2021.

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' property and will not obligate us to pay a referral fee.

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