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Consultant Director Global Clinical Development
Responsibility for clinical development strategy, clinical programs, clinical study concepts, scientific and medical aspects of clinical study protocols, clinical scientific issues during the performance of clinical trials.
Act as Medical Monitor for the assigned clinical study/studies – provide day-to-day medical oversight including safety data review and follow-up, protocol deviations assessments and responding to medical/scientific questions.
Provide strategic clinical input on the global clinical development plan of new therapeutic indications, both internal and external opportunities in line with the overall corporate strategy as relevant and appropriate
Provide strategic clinical direction, clinical development input to clinical and cross-functional team including Medical Affairs programs as relevant and appropriate
Address clinical scientific and medical issues related to one or more projects and indications in the organization.
Contribute to the clinical sections of IND, NDAs and BLAs, protocols, investigator brochures, medical reports, efficacy and safety summaries, scientific rationales, benefit/risk rations and SMPC/PI representing the Clinical function
Prepare for and participate in regulatory agency meetings as a Clinical representative representing the Clinical function
Serve as lead author or key contributor to clinical documents, including clinical trial protocols, reports and publications and integrated clinical documents for regulatory submissions.
Contribute to the clinical strategy of the clinical program(s) and to translation into sound Clinical Development Plans (CDPs).
Bear primary responsibility and accountability for quality and timeliness of clinical trial synopses and protocols.
Interaction with and management of CRO and other vendors
Interaction with and relationship building with Clinical Investigators and Key Opinion Leaders in the field of interest
Oversee or perform feasibility assessment and investigator/site selection
Manage and assist with Competent Authority and Ethics Committee/IRB submissions
Develop or approve monitoring plans
Approve the design, format and content of (e)CRFs and study guidelines
Oversee activities associated with clinical site start-up
Coordinate preparation and negotiation of investigator contracts
Manage and participate in Investigator Meetings
Resolve patient eligibility and protocol deviation issues
Oversee the overall Investigational product accountability and reconciliation process
Conduct co-monitoring/site visits as necessary to assess adherence to protocol and GCP for sites and vendors and to establish Sponsor relationship with investigators
Ensure timely resolution of data queries and integration of vendor data
Assist in preparation of Annual IND safety reports and ASRs
Address scientific and medical issues related to one or more projects in the organisation.
Pay special attention to serious adverse events and SUSARs occurring during clinical trials and potential safety signals.
Contribute to the clinical sections of regulatory files, including SmPC.
Assume lead role in review of data including listings and related items, communication planning and communication, review and preparation of topline data, and preparation of the Clinical Study Report
Assume lead role in planning and preparation, including speaker preparation, of clinical data presentations and publications for the appropriate and relevant clinical programs
Coordinate project close out, review/reconciliation of documents, reconciliation of project budget; coordinate project archiving with Clin Ops.
Contribute to the clinical components of "Due Diligence" and other clinical activities in support of Business Development and Licensing (BD&L) as relevant and appropriate representing the Clinical function.
Contribute to preclinical/clinical liaison work and collaborations to support smooth transitions of preclinical research to clinical development programs
Contribute to clinical/medical affairs liaison work and collaborations to support clinical development program understanding and key messages communicated externally
Maintain clinical expertise in program indications at hand and a knowledge base of new techniques, technologies, and relevant endpoints to apply to clinical development programs and study designs
Actively participate in planning and execution on Clinical Advisory panels and similar meetings and symposia relevant and appropriate to current and future clinical programs
Interact with relevant Health Authorities.
Coordinate project close out, review/reconciliation of documents, reconciliations of project budget; coordinate project archiving with Clinical Ops.
Participate in the preparation, review, updating and training of SOPs.
Support and back-up to Safety Physician role in Safety/Pharmacovigilance activities including medical evaluation of safety reports (individual and periodic)
Continuous QA improvement and cooperation with QA department
Any other duties the company may reasonably assign
Education & Degree
MD with further education seen as beneficial
Knowledge and Experience
10 years of experience in Clinical Development in Bio/Pharma industry (Sponsor and/or CRO)
Minimum of 6 years of clinical development project management experience.
Therapeutic Area experience strongly preferred
MS Office, good general IT capabilities
+- 5 year to 10 years
Higher Scientific Degree
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