Clinical Development Director

Clinical Development Director

Celyad

Mont-Saint-Guibert, Belgium

The successful candidate will be based in Mont-Saint-Guibert (Belgium) and will report into the VP Head Global Clinical Development and Medical Affairs located in Belgium.

Role & Responsibilities

  • Provide leadership and medical expertise to Company’s clinical development programs including pivotal studies;
  • Build effective relationships with site investigators and KOL’s;
  • Write clinical study protocols in collaboration with the CMO;
  • Review and provide medical/safety input of periodic benefit risk evaluation report, periodic safety update report, clinical expert statement, and so forth;
  • Effectively communicate with clinical operations/development staff, project management, IT, clinical QA, legal and other internal and external (CRO) staff and support as appropriate;
  • Support regulatory submissions including NDA;
  • Lead the development of clinical strategies for the innovative new drug candidates and drive successful implementation of such strategies;
  • Responsible for drafting clinical development plans, writing clinical trial protocol synopses and study protocols; leading discussions and revisions of study design with internal stakeholders and external experts/consultants;
  • Key physician contact for sites and investigators during site start-up and study execution:
    • act as a liaison between the company and clinical investigators;
    • develop credible relationships with opinion leaders;
    • participate in the medical review;
    • conduct safety/pharmacovigilance reviews;
    • interpretation and reporting of the results of the research, including submissions to health authorities.
  • Contribute to INDs, IMPDs and other regulatory submissions, and play an important role in the required regulatory interactions with the FDA, EMEA and other regulatory authorities;
  • Evaluate scientific information and new ideas to assist in identifying new research and development opportunities;
  • Perform all job responsibilities in accordance with standards of Good Clinical Practice (GCP);
  • Support regulatory strategies and interactions with global regulatory authorities;
  • Reviews all protocols prior to acceptance at the site for feasibility;
  • Reviews Investigator's Brochure prior to performing any study related activities;
  • Delegate study responsibilities as appropriate to trained study staff (clinical operations, clinical development and translational science).

Qualifications & Experience

  • MD or PhD in life sciences or scientific field;
  • Immuno-oncology experience and/or certification is a must;
  • Extensive experience in early-stage development (focus on human clinical trial design and translational medicine);
  • Thorough understanding of medical coding (MEDRA);
  • Thorough knowledge of basic and clinical cancer research and its application to cancer drug development;
  • Proficient in computer skills (Microsoft Office);
  • Pharma/biotech industry experience in clinical research is a must;
  • Fluent in English, any other language is an asset;
  • GCP training.

Skills & Competencies

  • Outstanding communication skills with a broad range of stakeholders (KOL’s, PI’s, Scientific Community, and so forth);
  • Drive and hands on attitude;
  • Good organizational skills;
  • Team spirit;
  • Strong business presentation skills;
  • Pro-active and assertive;
  • Effective decision making and sound judgement;
  • Result driven;
  • International travel might be required (<30%).

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Celyad     Belgium     Clinical Research     Manager and Executive     Medical     Pharmacovigilance and Medical Information     Physician     Regulatory Affairs     5 Years+ Experience    

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© EuroJobsites 2018

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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