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Job #03251

About our client Our client is the biotech division of a world-leading medical device company that has developed a reputation for successfully bringing complex products to the market in a variety of therapeutic areas. The company has strong financials, an experienced Management Team and a loyal customer base. They have developed an industry-wide reputation for a positive work environment and an aggressive training program that ensures employees are up-to-date on current trends and best practices. This is a strong opportunity for an Executive that wants to put their drive and initiative to work! Position Location Senior Manager of Clinical Affairs Tennessee Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee the project management and execution of pharmaceutical development projects including formation and development of project teams’ plan 2) Conduct and follow-up on regular Project Team meetings 3) Lead on-going project processes 4) Manage emerging internal/external project interface issues 5) Oversee the development, implementation and controlling of project budget and the utilization of Gantt and other project management tools 6) Advise and direct project teams in developing timelines and budgets of all activities associated with project initiation, conduct and completion of projects 7) Manage key new product development projects via coordination of Project Team meetings 8) Prepare and maintain Gantt task/ time-schedules and management of team objectives and deliverables 9) Liaise with/and manage cross-functional teams in-charge of development and strategic planning for products moving through the drug development process 10) Interface internally with Senior Management, Quality Assurance, Regulatory Affairs, Clinical, Pre-Clinical, Research, Manufacturing, Business and Commercial Development to plan, coordinate and facilitate product development activities from Pre-IND to commercialization 11) Interface externally with vendors, contractors, contract manufacturers, CROs and consultants to ensure communication and deliverables as per planned project objectives 12) Coordinate, review and aid in selecting/managing vendors, contractors, contract monitors and other outsourcing options to support project goals 13) Manage the project teams in conducting multiple studies for several products moving through the development pipeline, aiding in the prioritization of tasks 14) Execute and/or oversee all aspects of the development project to completion 15) Manage and/or oversee management of vendor activities 16) Identify and resolve Project Team challenges (pro-actively and independently) 17) Represent projects at key meetings 18) Report to Director of Clinical Affairs on administrative and functional matters 19) Ensure the timely completion and management of the Project Team activities to ensure project deliverables are aligned with estimated project timelines Requirements 1) BS in Life sciences or Healthcare background with 5+ years of clinical project management and 7+ years of pharmaceutical industry experience 2) 2+ years of experience in managing people (direct headcount) with CRO management and international trial expertise (preferred) 3) Experience in supervising projects including all phases of drug development as a Project Leader or Project Manager 4) Experience in creating or working tools to support project management (Microsoft Project) 5) Ability to communicate to project teams and generate clear/brief understanding of the roles and interdependencies of all functional groups required in the projects and how group functions are managed/sequenced 6) Accurate and practical understanding of the overall drug development process, as well as its stages, what is critical for accomplishment in each and how various aspects of the process can be leveraged for speed, cost and quality 7) Pro-active individual with an extrovert attitude and strong leadership, analytical, organizational, collaboration, communication (written and oral), problem-solving and general people skills 8) Ability to coordinate staff in a matrix structure from Manufacturing, Commercial, Regulatory, Quality, Clinical, Pre-clinical and Chemistry groups into functional matrix teams 9) Skilled at evaluating resource and budgeting needs and projections 10) Ability to function autonomously, with an affinity towards detail while cognizant of the big picture 11) Willingness to travel (internationally)