Mapp Biopharmaceutical Senior Advisor Clinical Operations in San Diego, California

Senior Advisor Clinical OperationsJob #19-02AiPart-Time (50%)Mapp Biopharmaceutical, Inc. "Mapp" is an innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases. The Senior Advisor Clinical Operations is responsible for providing deep technical expertise and assisting in the management of contract research organizations (CROs) and clinical development across programs at Mapp Biopharmaceutical.Basic Qualifications:Masters degree or equivalent with 20-years minimum of relevant experience in Clinical OperationsExperience in management, oversight, and execution of clinical trials conducted within and outside of the United StatesExperience in selection and management of CROs both within the United States and in AfricaPrevious experience conducting clinical trials and managing clinical sites and CROs in developing countries and in resource limited environmentsExperience making investigational drugs available to patients under FDA's expanded access regulations and other compassionate use provisions outside of the United StatesExperience interacting with ethical and regulatory authorities in central or western Africa or in equivalent countries with a similar settingPrevious experience developing investigational products for the treatment or prevention of rare diseasesExperience developing investigational products for the treatment or prevention of diseases in the context of ongoing epidemic(s)Experience with FDA Animal Rule requirements for licensing drugsDemonstrated ability to work remotely with domestic and international team and in the context of ongoing outbreaks or epidemics teamsWilling and capable to assist with multiple projects and responsibilitiesExperience in management of clinical studies in the United States and AfricaAbility to engage in domestic travel and international travel to the degree appropriate to support in-country operations and business of the teamUnderstanding of FDA, GCP, ICH and/or other regulatory requirements that may impact global clinical studies and clinical trial managementDetail oriented with proven organization, prioritization and collaboration skillsAbility to work independently in a virtual team environment as well as within multi-disciplinary project teamsExperience supporting government contractsOutstanding written/verbal communication and presentation skillsPreferred Qualifications:Ability to manage multiple projects in a dynamic team environment which requires creativity, innovation and thinking outside the boxAbility to influence colleagues and leaders in various departmentsCustomer focused, passion to succeed and promote team work with high integrityResponsibilitiesProvides guidance in all aspects of conducting IND studies (Phase I-IV and expanded access), with emphasis on study design, planning and managementProvides input and guidance on the selection, management and oversight of CRO and other vendors both within and outside the United StatesAssists the Mapp clinical operations team in providing technical leadership to its CROs through effective coaching and developmentManages and assists in training team members in Africa for their roles to ensure compliance with study requirements, GCP and ICH Guidelines, and applicable local regulationsProvides technical input and expertise to cross-functional project teams, prepares written and oral presentations, authors or reviews protocols, procedures, clinical study reports and collaborates/interacts with cross functional groups including Clinical Operations, Project Management, Regulatory and QualityProvides guidance and instruction to key clinical research personnel within Mapp and its subcontractors on current operating procedures, work instructions and project scopeAssists with tracking and oversight of activities related to project progress, budget, timeline and resource allocati