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Head of Scientific & Medical affairs - Belgium   The Head of Medical and Scientific Affairs manages the Clinical Development Plans, signs the Clinical Study Protocol and Clinical Study Report, leads the Medical and Scientific Affairs team and ensures medical and scientific input is given where needed wi

BrightOwl managed [?] Still accepting applications

Project Types : Permanent position ,
FTE : 100 %
Min.Experience : 10 year
Start Date : ASAP
End Date : N/A
Posted on : 27 June 2017

Project is currently here

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Application
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BrightOwl Screening
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BrightOwl Interview
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Company Screening
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Company Interview
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Budgets & Contracts
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Position filled

Project Description

  • Organize Medical and Scientific Affairs activities: manage and oversee the daily work of Medical and Scientific Affairs personnel and provide directions and support.
  • Ensure that the objectives set for Medical and Scientific Affairs are met; anticipate, identify and report any issues in a timely fashion
  • Report on a regular basis and as needed on the progress of the Medical and Scientific Affairs activities to the Management Team. These activities include Clinical Research responsibilities and Medical Affairs responsibilities
  • Ensure Medical and Scientific Affairs personnel is properly trained and motivated, provide coaching and/or assistance where and when needed
  • Support an open and constructive communication within the Medical and Scientific Affairs team as well as with the different departments within the company to allow efficient team work
    • Liaison with External Scientific advisors. Plan, organize and lead Scientific Advice meetings with external experts
    • Elaborate a protocol synopsis and review Clinical Study Protocol drafts
    • Review the Statistical Analysis Plan and Data Management Plan, and provide the Head of Clinical Operation with comments and improvements
    • Review the Clinical Study Report, provide additional analyses comments and improvements
    • Update the Investigator Brochure, including the Reference Safety Information and Guidance for Investigators

      Clinical Research responsibilities:

    • Provide Medical and Scientific support to Regulatory Affairs activities (EMA, FDA 

      ·       Organize Medical and Scientific Affairs activities: manage and oversee the daily work of Medical and Scientific Affairs personnel and provide directions and support.

      ·       Ensure that the objectives set for Medical and Scientific Affairs are met; anticipate, identify and report any issues in a timely fashion

      ·       Report on a regular basis and as needed on the progress of the Medical and Scientific Affairs activities to the Management Team. These activities include Clinical Research responsibilities and Medical Affairs responsibilities

      ·       Ensure Medical and Scientific Affairs personnel is properly trained and motivated, provide coaching and/or assistance where and when needed

      ·       Support an open and constructive communication within the Medical and Scientific Affairs team as well as with the different departments within the company to allow efficient team work

       

      Clinical Research responsibilities:

      ·       Liaison with External Scientific advisors. Plan, organize and lead Scientific Advice meetings with external experts

      ·       Elaborate a protocol synopsis and review Clinical Study Protocol drafts

      ·       Review the Statistical Analysis Plan and Data Management Plan, and provide the Head of Clinical Operation with comments and improvements

      ·       Review the Clinical Study Report, provide additional analyses comments and improvements

      ·       Update the Investigator Brochure, including the Reference Safety Information and Guidance for Investigators

      ·       Provide Medical and Scientific support to Regulatory Affairs activities (EMA, FDA meeting e.g.) and to Clinical Operations (Investigator Meetings)

      ·       Review (and participate with writing) the Development Safety Update Report

      ·       Review (and participate with writing) the Risk Management Plan and Efficacy and Safety sections of the eCTD

      ·       Participate to the development and maintenance of a Clinical QA system

       

      Medical Affairs responsibilities

      ·       Execute the Presentations and Publication plan

      ·       Public relations with Key Opinion Leaders and Patient Organizations in the framework of Scientific and Medical Affairs mission

      ·       Provide Medical Education and Training (including preparing/approving materials); review and approve publically available materials

      ·       Perform regular and ad hoc literature reviews and participate to key congresses to stay up to date with key scientific and medical knowledge (e.g. competitive intelligence)

      ·       Elaborate and keep up to date a Target Product Profile for each product

      ·       Support the elaboration of a Global Value Dossier

      ·       Provide Medical and Scientific support to Marketing and Sales (e.g. training, presentations at congress and meetings, local reimbursement)

      ·       Ensure International and National laws and regulations are respected (Code of Practice)

       

Others

Project FTE 100%
Work from home:   Not Allowed
International Travel:   Yes
No. of Positions:   1

Knowledge

Immunology immunotherapy Allergy and immunology respiratory diseases

Skills and Expertise

Communicate effectively on different company levels Presentation Skills Team Player flexible

Degree

Medical Degree

Field of study

Biotechnology (Optional)
Immunology (Optional)
Medicine (Optional)

Languages

English
Full Proficiency
Mandatory
French
Professional Proficiency
Is a big plus

Desired Skills & Experience

  • Must have a medical degree.
  • At least 10 years experience with international clinical development at Head Quarters level, experience with Clinical Development Plans and processes, writing of phase II/III clinical study protocols, clinical study reports and regulatory submission documents (eCTD).
  • Experience with meeting and communicating with regulatory agencies. Having participated to successful EU and/or US registration(s) is an asset
  • Excellent and up to date knowledge of international guidelines related to GCP and conduct of clinical trials
  • Experience with immunotherapy, immunology, allergy and/or respiratory diseases is an asset.
  • Experience with Medical Affairs at Head Quarter level is an asset.
  • Excellent organizational and communication skills.
  • Excellent presentation skills.
  • Team player, flexible, conflict handling and problem solving skills.

Very good spoken and excellent written English.