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Jobs at Aurum

Careers at Aurum Biosciences

 

Title: Medical / Clinical Consultant

 

Reports to: Jim McGuire, CEO / Gerry McGettigan, Executive Chairman

Based at: Home based, requirement to come to office as needs

FTE: On average, 1 day (8 hrs) per week

1.  CLINICAL DEVELOPMENT

Advise and assist on the design, initiation, conduct and interpretation of data of clinical trials for ABL-101 and any other company products. Contribute to a corporate culture of medical and scientific rigour and ethical behaviour.

This includes:

  • Input into protocol content and writing, where appropriate
  • Input into CRF, TMF or other documents or documentation, where appropriate
  • Advise on required company processes and procedures to comply with GCP and all other relevant international (ICH, EMA / CHMP, FDA) clinical / regulatory requirements
  • Review of trial data and advice on, and interpretation of, the results thereof
  • Review and editing of Clinical Study Reports
  • Review of publications
  • Liaise with external parties regarding clinical study contact, e.g. investigators, NHS, GU, statisticians, pharmacy
  • Advise on specific clinical development aspects related to Regulatory Affairs, including Scientific Advice, Paediatric Plans, CTAs / INDs etc.
  • Advise on specific clinical development aspects related to Quality Assurance, including documentation requirements, SOPs etc.

2.  SAFETY, PHARMACOVIGILANCE

Interpreting data and advising on decisions related to the Investigator-Led Phase 2a Study of ABL-101 in Acute Stroke to start mid 2018, as required by the study sponsors, Glasgow University and NHS GGHB, and the company.
Advise on any other safety or pharmacovigilance related matters relevant to the company and its products under clinical development.

3.  SCIENTIFIC ADVISORY BOARD

Assist with the agendas of, and communication with, the SAB including advice on potential new clinical developments with ABL-101 and / or other company products.

4.  CORPORATE CULTURE

Synthesize information into clear, timely, accurate and consistent messages and guideposts for the company as this relates to medical and clinical matters, and consistent with GCP and other international regulatory requirements.
Ensure that all colleagues are aware of the highest standards of professional behaviour required for a company dedicated to, and involved in, clinical trials, including the expected level of quality of both verbal and written communication. This relates to internal and external communication with all parties involved in clinical trials.

5. CANDIDATE PROFILE

The candidate should have a proven expertise and experience in all key aspects of the role. This is likely to be a minimum of 10 years employed in clinical development roles at recognised pharmaceutical or biotechnology companies. The candidate should ideally have a medical degree but applications from scientists with relevant clinical development experience are also actively encouraged. The candidate should have an intimate knowledge of all relevant clinical and regulatory aspects of the drug development process.

If interested in this opportunity please send an up to date CV and a supporting letter to dbrennan@aurumbiosciences.com.