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Job #02567

About our client A global CRO that serves the pharmaceutical, biotechnology and medical device industries, our client is built upon a strong foundation of clinical, process and systems expertise. They specialize in major therapeutic areas such as oncology and dermatology. The company has supported more than 51 FDA approvals to date, with no refusals among submissions accepted for filing. Position Location Director of Clinical Affairs New York Salary Highly competitive package, commensurate with experience Responsibilities 1) Provide leadership and supervision to the Clinical Affairs Group 2) Oversee client interaction 3) Define and manage project requirements, deliverables, schedule adherence and budgets 4) Monitor resource needs and manage staff 5) Promote SOP and policy compliance as well as use of tools and metrics 6) Develop and manage the Project Management Department 7) Manage consistency of project management and clinical monitoring regarding project requirements, deliverables, schedules and budgets 8) Communicate with clients and client project managers to promote project schedule adherence 9) Ensure that projects are adequately staffed with personnel and resources 10) Meet high quality standards 11) Oversee development and maintenance of operations and procedure manuals, work guidelines, department metrics and project tools 12) Coordinate training and education programs to ensure staff is trained (as needed), including, but not limited to relevant therapeutic areas, ICH guidelines and regulatory requirements 13) Assist in managing and monitoring departmental budget 14) Monitor departmental billable percentages 15) Work closely with clinical project managers to promote operational efficiency, teamwork and high morale 16) Interact with clients in a customer service role to ensure solid team relations 17) Collaborate with staff, both- inter and intra-departmentally, on the proposal development process 18) Assist in Operations meetings and directives to improve departmental and corporate policies and procedures 19) Direct projects involving monitoring, database management, data management/entry, programming, statistics, report writing and agency presentations 20) Make presentations and represent the company in professional meetings and in front of prospective and existing clients 21) Manage personnel activities and provide guidance for professional development of staff 22) Coordinate resource distribution across projects, interviews, make hiring recommendations, lead disciplinary actions, deliver performance reviews, etc. 23) Act as back-up for project managers 24) Perform other tasks as assigned Requirements 1) BS/BA (advanced degree preferred) 2) Minimum of 5+ years of project management experience with a CRO 3) 5+ years of management experience 4) 5 years of clinical trial experience 5) Excellent knowledge of at least two departmental processes and functions within the pharmaceutical industry and drug development process 6) Ability to handle multiple projects simultaneously and multi-functional teams (preferred) 7) Extensive creative, problem-solving and communication (oral and written) skills preferred 8) Strong leadership, management, time management, organizational and computer skills preferred