Clinical Sciences/Clinical Development Director Respiratory – Europe or US

Key Responsibilities

• Lead, manage and mentor Clinical Sciences respiratory projects and ensure timely delivery of all deliverables. The responsibilities of the company Medical Monitor may include but is not limited to the following: Contribute and/or provide review to key study related documents such as protocols, informed consents and amendments, eCRFs, SAP, MMP, SMP, and TLFs.
• Review of CRO medical monitoring capabilities as part of study start up and RFP process including the CRO MM CVs, MMP, and investigator/site lists as part of the vendor selection process or final CRO determination.
• Provide guidance on subject eligibility, deviations, and other medical, safety, or protocol related questions to CRO MM, site investigators, and CRO and Sponsor study team.
• Review of blinded efficacy and safety data, listings, tables, deviations, and provide supportive review of blinded SAE or SUSAR related documents and address or elevate any data ...