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Job #03063

About our client Our client is a leading provider of contracted drug development services to the pharmaceutical industry. Their services span from pre-clinical through manufacturing, clinical, regulatory and commercial phases of drug development. Our client’s executive team are accomplished leaders in the full spectrum of drug development and have extensive experience working in and with pharmaceutical, biotech and contract services organizations. Position Location Vice President of Scientific and Clinical Affairs Cincinnati, Ohio Salary Highly competitive package, commensurate with experience Responsibilities 1) Lead the clinical consulting practice 2) Provide strategic and operational leadership to current and potential clients by integrating protocol design and preparation, clinical conduct, clinical monitoring, data management and statistics, etc. 3) Ensure that the overall scientific and medical content of all clinical programs is accurate 4) Ensure the integration of pre-clinical and early clinical findings with planned clinical programs 5) Secure cross functional alignment and/or transparent discussion of risks associated with clear plans to investigate and track clinical development 6) Prepare clinical development plans and institute properly designed clinical protocols 7) Design scientifically rigorous and maximally cost-effective clinical development programs for the desired indications 8) Present and defend protocols to internal management, client and FDA as well as other regulatory authorities 9) Satisfy and exceed the clients’ clinical needs 10) Establish expertise and the company clinical team as the experts for 505(b) clinical programs 11) Build the clinical consulting business 12) Represent clinical expertise to clients in conjunction with Business Development and Marketing 13) Identify business opportunities 14) Develop plans and budgets for potential business opportunities 15) Establish critical business needs to support a growing clinical business 16) Build and improve the Clinical Team 17) Coach and develop existing CMC Team members 18) Hire the best Clinical Team members 19) Provide guidance to the Clinical Team regarding the appropriate clinical activities to be performed at the various stages of development, for enhancing the timely integration and alignment of all functions 20) Ensure the timely initiation of clinical-related activities and that activities are consistent 21) Build and improve the intra-departmental activities 22) Develop and apply resource and capacity models 23) Work with the company team to define, build and communicate the matrix structure across the various functions 24) Develop, maintain and communicate product development plans, timelines, milestones and budgets consistent with company operating objectives 25) Integrate and align clinical activities with client development program objectives 26) Understand and optimize the relationship of clinical activities with research, pre-clinical, CMC and regulatory objectives 27) Develop risk mitigation strategies 28) Facilitate and guide decision making 29) Consolidate key cross-functional information to decision makers (i.e. clients and internal staff 30) Develop business processes and systems to support and streamline Clinical Team activities 31) Work globally to implement processes and systems 32) Develop metrics and continuous improvement initiatives 33) Identify and develop (effectively) project management tools and methods to ensure documentation, communication as well as performance Requirements 1) Ph. D., MD or Pharm. D. (MS degree will be considered only with significant experience) 2) Fellowship or training and certification in Clinical Pharmacology or Pharmacokinetics 3) 7+ years of experience in the pharmaceutical industry 4) Prior experience at a senior management, leadership role in clinical research design/implementation of protocols, review/interpretation of data 5) Direct clinical research and managerial experience 6) Knowledge of the clinical development process 7) In-depth knowledge of clinical trial management, data management and drug development process 8) Understanding of human disease, pharmacology, biochemical medicine and the relevance of pharmacodynamic/clinical endpoints that underlie the action of the drugs being developed 9) Ability to work collaboratively in a team environment, including client companies in and outside the US 10) Willingness to travel domestically and internationally (up to 25%)