Publiée le 09 mars
Description de l'offre
Due to continued growth, PPD is now looking to appoint an Medical Director, Haematology, to join our client-dedicated team of Medical Directors in EMEA/NA. This role can be office-based or home based.
This position provides strategic leadership and tactical oversight for the clinical/medical aspects of all phases of the clinical drug development process. This person is responsible for the design, development and execution of Clinical Development Plans (CDPs), clinical trials and protocols in accordance with applicable GCP regulations. This person leads and contributes to the analysis of study results, the assessment of the extent to which the study(ies) has achieved clinical/regulatory objectives and the documentation of study results.
This person may act as a clinical/medical representative in meetings with external stakeholders (e.g. collaborators, Key Opinion Leaders (KOLs), investigators, regulatory authorities, etc.), partners (e.g. vendors, consultants, etc.) and other external audiences as needed.
* Provides medical content and leadership of the clinical studies
* Medical Monitoring of clinical studies
* Establish and approve scientific methods underlying the design and implementation of clinical protocols
* Regularly review adverse event, laboratory and other clinical data, ensure reporting is done on a timely basis
* Collaborate with the study executive and independent safety committee when needed
* Represent clinical research through membership on trial teams.
* Contributes to, reviews and approves study protocols, protocol amendments, study manuals, Investigator Brochures (IBs), Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs) and other clinical documents as required for the conduct of clinical trials
* Interprets, summarizes and documents clinical data for regulatory documents (e.g. INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications as required.
* Collaborate with leading academic medical centres
* Ensure study compliance by understanding and applying all relevant SOPs and GCPs
* Participate in long range strategic planning
Ranges, Clinical Research, Vigilant, Strategic Planning, Protocols, Annual Reports, Hematology, Clinical Monitoring, SOP, Clinical Research, Clinical laboratory, Medical Center, Informed Consent, Process Development, Design, IBS, Health & Safety, Trials, Medicine, Leadership, CSRS, EMEA, Committees, Clinical Research, Publications, Reporting, Manuscript, Engagement, Analysis, Brochure, Therapy, Clinical, Science, Vendors, Implementation