Associate Director, Clinical Operations
Manages all aspects of clinical operations for assigned project(s). This includes contributing to the strategic and operational leadership relative to the direction, planning, execution, and interpretation of clinical programs and the data collection activities. Works with senior Clinical Operations management to establish and approve (with CRO, Program Executive or Clinical Managers) scientific methods for design and implementation of clinical protocols, data collection systems and final reports. May also have responsibility for partnered programs in the areas of training, labeling, package design & pulmonary drug development. Monitors adherence to protocols. Interacts with various inside/outside groups to facilitate clinical programs. May select, develop, and evaluate personnel to ensure the efficient operation of the function. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.
Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgments within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Ensures budgets, schedules and performance requirements are met. Contributes to the development, management, and execution of the Clinical Development Plan (CDP) which includes timelines, budget, and resource requirements. Contributes to the development and implementation of the clinical program strategy and manages those systems and programs in order to meet Company goals and objectives. Provides strategic input into the CDP. Aides in the management of program advisory committees and/or expert consultants. Identifies program/resource gaps and proposes solutions. Provides weekly enrollment and program updates to senior manager. Ensures that Clinical Operations department functions effectively internally. Proposes innovative ideas to help resolve challenges faced by the project team. Remains current with medical developments and publications on similar and competitor products. Applies this knowledge to current programs. Manages internal staffing and performance management, including hiring, training, coaching and performance reviews. Mentors and develops clinical operations staff.
A Bachelors/Masters degree in a scientific discipline is required. Equivalent experience may be accepted. A minimum of 10 years Pharmaceutical development experience with at least 4 years managing CROs is required. A minimum of 8 years previous management experience is may be required. Must have demonstrated ability to solve problems with innovative solutions along with strong organizational skills. Excellent written and verbal communication skills are required. Experience and understanding of ICH, and GCP is required. Knowledge of GMP and GLP is preferred. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must possess excellent project management skills. Must have strong computer skills with a proficiency in Microsoft Project, Word, Excel, Visio, and PowerPoint.