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Job Details

Senior Director/Director Clinical Development

Company: Barrington James Clinical
Location: Berkshire/Bedfordshire
Reference: AMJN: ONCOLOGY
Closing Date: 25 Jul 18
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

I’m working on a search for a global biopharma based in the UK looking for a senior clinical development expert to assist with the growth and development of their leading oncology portfolio.  This opportunity offers an experienced medic the chance to transition into a more senior position reporting into the Vice President, as well as allowing them exposure into multiple therapy areas besides Oncology.

Requirements:

Responsibilities:   To provide strategic input to long range planning Western Development recommendations.

  • To be responsible for the overall robustness of the study data (evaluation scales, primary endpoint measures, etc.).
  • To perform medical monitoring, create Medical Monitoring Plan, interacts with study site personnel on protocol-related medical issues, resolves errors and inconsistencies in clinical data with Biostatistician and other study team members, as necessary.
  • To provide study-specific and/or therapeutic training and education for internal and external study team members and WDO colleagues if applicable.
  • To be responsible for publication strategy/plan and co-ordination, reviews/authors publications if applicable.

Requirements

  • M.D. degree (or equivalent) with an post-graduate medical training
  • Additional post-graduate degree (e.g. PhD, MBA etc.) would be desirable
  • Extensive industry experience, especially on clinical development within Hematology/Oncology therapeutic area.
  • Experience in biologics development with MAA/BLA submission would be desirable
  • Experience in writing and conducting clinical protocols in all phases of clinical development , with in-depth understanding of the scientific methodology and clinical research based on scientific and medical principles
  • A good knowledge of ICH-GCP, FDA and EMEA regulations and guidelines, as well as applicable international regulatory requirement

  

 

Apply for this job: Senior Director/Director Clinical Development

Contact Information:

Address:  Head Office
Victoria House Consort Way Horley Surrey
RH6 7AF
England
Tel:  01293 776644
Fax:  01293 822333
Website:  Visit Our Web Site

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