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 Job #02766 Email this job to a friend
About our client
Our client is an international CRO headquartered in New York that is focused on the development and commercialization of various oncology and dermatology therapeutics. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees.
Position Location
Director of Clinical Affairs Rye Brook, 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 that the 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 superb team relations
17) Collaborate with staff, both inter- and intra-departmentally, on the proposal-development process
18) Assist with operations meetings and directives to improve departmental as well as 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) 5+ years of industry experience, including minimum 5 years of clinical trial experience
3) 5 years of project/team management experience in a CRO preferred
4) Experience in people management
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) Creative problem-solving and communication (verbal and written) skills
8) Excellent leadership and management skills
9) Superb time management, organizational and computer skills

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