Clinical Development Scientist

Job description

Details:
As a Clinical Development Scientist you will be expected to provide clinical development expertise into a multi-disciplinary matrix team overseeing the early clinical development of assets in the immune inflammation portfolio within Cytokine and Chemokine Discovery.

This role will be part of the Immuno-Inflammation Therapy Area and is focused on the discovery and early clinical development of biological and small molecule modifiers of complement, cytokine and chemokine biology.

The role also has the potential to act as the Clinical Investigative Leader for assigned early phase assets, providing support and expert scientific/clinical input to the planning, development, and implementation of early clinical development programmes. This role would be a great opportunity for someone with an enquiring attitude and the ability to think innovatively in experimental medicine study design to work across an exciting pipeline targeting immuno-inflammatory diseases.

Key responsibilities:
• Develop scientific expertise on the clinical development for assigned compounds
• Lead or contribute strategic input to the clinical development plan
• Key contributor into the translational package / biomarker strategy for a compound
• Act as the clinical representative on Study Conduct Teams to ensure the clinical/scientific integrity of the study, and that trials are conducted effectively within budget- and time-constraints in order to deliver submission-quality data
• Develops and writes relevant sections of clinical documents such as study protocols, study procedure manuals, patient informed consent, written responses to IRB/Ethics Committees, clinical study reports and scientific publications
• In partnership with the Medical Monitor, provides clinical protocol training to internal and external groups (including at Investigator Meetings)
• Support of regulatory interactions (e.g. contributing to the creation of regulatory documents such as Investigational New Drug / Clinical Trial Applications, Regulatory Briefing Documents, and Investigational Brochures, support/attendance at regulatory meetings as required)
• Key contributor to the review of study data, interpretation of results and internal / external communication of study conclusions.
• Actively engages and integrates external academic and clinical trial expertise and resource to enhance quality and delivery of experimental and clinical development trials.
• Drive presentation and publication of clinical and scientific outputs
• Work with and provide clinical support to the global clinical matrix teams, including late stage clinical development, regulatory and commercial experts, to deliver the overall needs of the medicine development strategy
• Must be able to manage and influence effectively across multiple geographies, cultures and time-zones in a matrix environment.
• Must be able to interface seamlessly with other functions and groups within GSK, as well as external regulatory agencies to advance clinical assets effectively
• Must be able to ensure alignment of Clinical Strategy for external collaborations

If requiring an adjustment for a disability, once selected for
Interview you may contact

Closing date for applications: 08th March 2017

When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.
The information that you have provided in your cover letter and CV will be used to assess your application.

Thank you for your interest in this opportunity.

*LI-GSK

Contact information:
You may apply for this position online by selecting the Apply now button.

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Desired profile

Basic qualifications:
• Bachelors degree in Biomedical or Health Care related specialty; advanced degree preferred (e.g. PhD, PharmD)
• Demonstrated experience in clinical research and the design and conduct of clinical studies, including knowledge and understanding of ICH/GCP guidelines and SOPs
• Strong scientific background; good knowledge of basic or clinical immunology preferred
• Flexible, focused, enthusiastic, self-driven and highly motivated
• Maintains a disciplined approach, ensuring a relentless focus on detail, quality, compliance and operational excellence
• Excellent interpersonal skills and experience of working collaboratively with teams in a matrix environment across functional and geographic boundaries; understands the necessity of a strong partnership with colleagues (e.g. Clinical Operations, Regulatory, Safety)
• Able to prioritise effectively, and rapidly assimilate information from a disparate range of sources.
• Proactively identifies problems and recommends solutions
• A proven ability to deliver clear and effective scientific messages both orally and in writing

Preferred qualifications:
• Clinical research expertise and experience in the early phases of drug development preferred
• Ideally sound knowledge of the immuno-inflammatory therapeutic area
• Has experience in the successful design and conduct of biomarker-focused experimental medicine studies