Clinical Science Director
- Experience Level
- Senior Management
Hobson Prior are seeking for a Clinical Science Director to join a leading pharmaceutical organisation in London on a permanent basis. In this role you will be responsible for all clinical scientific aspects and strategic planning of one or more clinical projects.
- To establish and evaluate on an ongoing basis a development project strategy and clinical development plan in line with the corporate objectives and to maintain a state-of-the-art CDP that is consistent with the latest regulatory requirements and competitive environment.
- Working closely with different in-house functions and appropriate external groups/individuals to ensure all risks are identified and plans implemented to allow the rapid resolution of scientific or regulatory issues and the successful completion of the project.
- Providing appropriate review, interpretation and management of both clinical and non-clinical data and make appropriate recommendations to streamline and expedite the development project and support potential go/no-go decisions.
- Ensuring each protocol is designed with scientific integrity with the endpoints clearly addressing the protocol objectives and that the protocol addresses one or more of the strategic project aims, in addition to overseeing the scientific integrity of each study.
- Specifically analysing potential issues and risks that affect the project, particularly those that affect the quality and integrity of the data and safety of the drug.
- Where the specific area of expertise is not in-house, identify a suitable external expert for appropriate input.
- Contributing to the development of the Target Product Profile for the project.
- Contributing to the development of the Translational Research Plan for the project.
- In liaison with regulatory colleagues, development of regulatory documentation and setting-up, preparing and presenting at meetings with regulatory agencies. Reviewing and approving study documentation as appropriate.
- Providing input to study operational issues where appropriate to allow the efficient set up, implementation and reporting of the study.
- Providing leadership and support to the internal and external project team.
- Manufacturing Practice regulations and ensure training in these areas is kept up-to-date at all times.
- Excellent oral and written communication, organisational skills and personal presentation.
- Ability to communicate effectively in English.
- Good experience of interpersonal and communication skills when dealing with internal and external clients/vendors, supporting colleagues and making presentations.
- Excellent IT Skills.
- Bachelor's degree (scientific/medical) or higher; advanced degree is preferred.
- Demonstrable experience of a number of therapeutic areas.
- Experience working in a team environment under time and resource pressures.
- Able to organise and oversee multiple on-going tasks and understand the differing priorities.
- Must have excellent project management and time management skills, a flexible approach and be able to adapt in a changing environment.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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