Programme AD/Director

SoseiHeptares Cambridge 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 its proprietary G Protein-Coupled Receptor (GPCR)-targeted StaR® technology and Structure-Based Drug Design (SBDD) platform capabilities. We are 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 161 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

Purpose:

To lead drug development programmes from late phase Discovery/Candidate Selection onwards

  • Responsibilities will vary depending on the stage/needs of the programme and requirements within the Development group.

  • Programmes will include preclinical projects moving towards clinical development as well as clinical phase projects

  • Additional non-project leadership and management level roles may be required

  • Programme directors may also have line management responsibilities.

Reports to: Head of Project Management

Key responsibilities

  • Leadership of one or more development project teams ensuring effective team performance utilising the full scientific and operational expertise within the team
    • Establish the project development strategy through effective engagement with the multidisciplinary team and if appropriate engagement with external key opinion leaders/experts
    • Establish/maintain the overall development plan and ensure delivery to agreed standards of quality, time, and cost.
    • Ensure that plans are aligned with strategic /portfolio and budgetary needs.
    • Seek opportunities to accelerate timelines in a cost-effective manner and/ or response to portfolio needs to modify project timelines/ budget.
    • Identify information requirements for key decision points and undertake “what if” analyses to ensure timely progression.
    • Ensure that a risk management strategy is in place for the project and that this is regularly reviewed, updated, communicated, and identified mitigation strategies are implemented.
      • Critically review project findings to identify issues/ risks/ opportunities and work with the team to recommend strategies and plans to address the issues.
    • Maintain awareness of the competitive position (mechanism and therapeutic area)
    • Prioritise work or individual team member activities as required.
    • Through discussion with Development functional leaders ensure adequate resource allocation
    • Contribute to overall pipeline management and coordination.
    • This may include being a member of various management/governance bodies, formal Alliance manager for external partnerships and leading initiatives for the benefit of the whole of development.
  • Design and execution of studies
    • Contribute to the successful and timely execution of nonclinical and clinical studies by working in collaboration with team members, external consultants, pre-clinical or clinical investigators and CROs as required.
  • Documentation
    • Act as project information custodian and keeper of programme ‘dataroom’.
    • Where appropriate, lead and/ or directly assist in the preparation of regulatory documentation to agreed timescales
  • Communication
    • Be spokesperson for the project presenting with authority to a variety of internal (including Quarterly Development Review (QDR) forum) and where required, external audiences including scientific, development, regulatory and commercial parties.
    • Organise and generally act as chair for project team interactions. This may include regular meetings; leading agenda setting and ensure minutes are documented.
    • Communicate effectively with team members, internal management/ groups/ individuals, and external parties ensuring timely and accurate information flow.
      • As requested, provide information to Line Manager/ Management body
      • For urgent matters arising, a programme director is expected to escalate information promptly to relevant management.
    • Alert their Line Manager to significant positive or negative aspects regarding effective stakeholder performance.
  • Governance interactions
    • As requested, provide project information to Governance authority (e.g. Board)
      • For QDR: prepare regular quarterly updates to documentation
  • Business development and due diligence
    • If requested, contribute to business development activities and due diligence assessments satisfying the timelines required.
  • Financial and contract tracking
    • Maintain financial plan for a programme and/or specific study
    • Provide input to company financial forecasts
    • Ensure appropriate contract negotiation, implementation, and supervision.
    • Provide pertinent updates for formal financial audits (including supporting proof).
  • Training
    • Maintain ongoing professional development relevant to the role including scientific and clinical awareness of relevant therapeutic areas
    • Maintain awareness of relevant current regulatory and guidance relevant to tasks assigned.
    • Ensure required training relating to Development quality expectations, therapeutic area training, study/programme specific training and GxP requirements is completed at the required time and maintain adequate documentary evidence of such training.
    • Communicate training requirements when additional training is required in order to perform assigned tasks
  • Ensure best practice is adopted within the programmes
    • learning from other projects, interacting with discovery and external publications

Requirements

Core Skills Required

  • Technical and practical experience of all drug development including nonclinical and clinical development activities
  • Knowledge of drug development quality requirements including GCP
  • Demonstrated leadership capabilities
  • Ability to manage successfully a varied workload and multi-task.
  • Ability to work independently or as part of a team.
  • Ability to exercise sound scientific and clinical development judgment through understanding of drug properties/ mechanism of action/ therapeutic indication.
  • Ability to, identify, engage and manage a variety of specialist consultants.
  • Good communication skills both written and verbal (English).
  • Ability to be proactive and use initiative.
  • Ability to ensure accuracy, with good attention to detail.
  • Be self-motivated, focused and delivery orientated.
  • Maintain an active interest in the Company and its objectives.
  • The postholder will be responsible for adhering to all health and safety guidance, provided by the company.

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. This job description will be reviewed during the annual performance review process.

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’ with your application in pdf format, quoting reference number 2021-PM-Prog-Dir. The closing date for applications is 31st October 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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