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Sensorion, le début d’une belle aventure

CLINICAL RESEARCH PHYSICIAN F/M

Paris - CDI

Poste

Sensorion is recruiting a Clinical Research Physician F/M on a permanent basis contract (CDI) based in Paris or Montpellier.  

 

Reporting to Head of Medical Department, the Clinical Research Physician F/M  is the primary clinical expert for the study.. The main role of the CRP is to lead, support and oversee the good execution of clinical activities of the study under his/her responsibility. The candidate must be a well-organized, autonomous with self-motivation and the ability to deliver on multiple medical tasks. The candidate will work in cross-functional environment with interactions with all internal and external stakeholders involved in the trial. This position requires strategic and operational competencies

 

Main Activities

    • Participate to clinical development plan
    • Contribute to the definition of Target Product Profile (TPP)
    • Collaborate and build a strong relationship with external partners.
    • Perform review of the literature to evaluate relevant medical information and status of the competitors.
    • Review or drafting supporting documents for the study (synopsis, protocol, investigator brochure and inform consent form, case report form and patient diary, etc.);
    • Participate in regulatory submissions and discussions with health authorities / ethics committee in conjunction with the regulatory department;
    • Contribute actively to develop the SAP
    • Review and validation of clinical data during the study and coordination of data analysis;
    • Responsible for the preparation of key results
    • Control of the progress of clinical studies;
    • Closely interact and collaborate with internal stakeholders and external providers by managing subcontracted activities (statistician, PV, experts…).;
    • Control, review and validation of clinical study reports and publications of clinical study results;
    • Responsible of the quality of clinical documents according to international standards and internal procedures;
    • Establishment and animation of networks of investigators and opinion leaders;
    • Presentation of clinical development projects to health authorities, investigators, opinion leaders and congresses;
    • Review and follow-up of adverse events, review of narratives (initial/follow-up), write or review annual safety reports.
    • Provide medical support to clinical operations team.

Profil

    • Diploma:
      • State Diploma of Doctor of Medicine or PhD or equivalent

 

    • Prior Experience:
      • At least 5 years of experience in a similar position
      • Significant experience in a health industry: biotech, pharmaceutical industry, health industry provider, etc;
      • Expertise in a rare disease and/or in gene therapy would be a plus.
    • Tongues:
      • Fluent in French & English

 

    • Crossfunctional skills:
      • Able to work in international and intercultural working context.
      • Very good teaching skills,
      • Have operational and fluent English;
      • Be comfortable and effective in communication, while being diplomatic;
      • Work as a team and cross-functionally ((R&D, Regulatory Affairs, Quality, Legal, Marketing and Finance);
      • Have writing skills and a capacity for analysis and synthesis;
      • Be rigorous, autonomous and dynamic;
      • Have a keen sense of listening and communication;
      • Be flexible, reactive and adaptable;
      • Open-minded for innovations and new solutions.
      • Have ethics (respect for the patient and the confidentiality of this data);
      • Comply with company policy.

 

    • Business skills:
    • Strong understanding of pharmaceutical product development
    • Scientific and medical expertise
    • Have a methodological approach to clinical studies, analysis, use of study results, statistical processing and bibliographic research;
    • Able to challenge the status quo with innovative approach of the clinical development plan
    • Have medical knowledge, clinical trial procedures and good clinical practices;
    • Know the guidelines and regulatory references in medical writing (clinical and regulatory documentation);
    • Know how to write clinical study documents and scientific publications according to regulatory standards;
    • Analyze, interpret and synthesize data from pre-clinical / clinical studies;
    • Proficiency in MS Word, Excel, Powerpoint and Adobe Acrobat Professional.

 

 

 

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CAUTION!

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