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Job #02965

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 to manufacturing, clinical, regulatory and commercial phases of drug development. Their executive team members 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 CMC Cincinnati, Ohio Salary Highly competitive package, commensurate with experience Responsibilities 1) Lead the CMC consulting practice 2) Provide strategic and operational leadership to current and potential clients by integrating pharmaceutical development, manufacturing, quality and regulatory functions for early- and/or late-stage small molecule development programs 3) Identify client program needs and evaluate them for strengths and weaknesses 4) Assist the client in overcoming deficiencies 5) Satisfy and exceed the clients’ CMC needs 6) Build the company business 7) Represent CMC expertise to clients in conjunction with Business Development and Marketing 8) Identify business opportunities 9) Develop plans and budgets for potential business opportunities 10) Establish critical business needs to support a growing, thriving CMC business 11) Build and improve the CMC Team 12) Coach and develop existing CMC Team members 13) Hire excellent personnel for the CMC Team 14) Guide the CMC Team on appropriate CMC activities to be performed at various stages of development, for enhancing the timely integration and alignment of all functions 15) Ensure the timely initiation of CMC-related activities and that activities are consistent 16) Build and improve intra-departmental activities 17) Work with the company team to define, build and communicate matrix structure across the various functions 18) Develop and apply resource as well as capacity models 19) Integrate and align CMC activities with client-development program objectives 20) Develop, maintain and communicate product development plans, timelines, milestones and budgets 21) Understand and optimize the relationship of CMC activities with research, pre-clinical, clinical and regulatory objectives 22) Develop risk-mitigation strategies 23) Facilitate and guide decision-making 24) Consolidate key cross-functional information to decision makers 25) Develop business processes and systems to support and streamline CMC Team activities 26) Work globally to implement processes and systems 27) Develop metrics and continuous improvement initiatives 28) Identify and develop (effectively) project management tools as well as methods to ensure documentation, communication and performance Requirements 1) BS/MS/Ph. D. (Pharmaceutical Sciences, Chemistry or Engineering) 2) 8 –12 years of experience in the pharmaceutical industry 3) Experience in a CMO or prior consulting experience a plus 4) Practical CMC experience in a technical role (in the pharmaceutical industry) 5) Experience in clinical, pre-clinical and regulatory operations in drug development 6) Excellent leadership, organizational and project-management skills 7) Superb communication, negotiation, problem-solving and decision making skills at all levels of the organization 8) Ability to work collaboratively to connect vision, strategy and goals