This includes strategic and operational leadership relative to the direction, planning, execution, and interpretation of clinical programs and the data collection activities. Establishes and approves (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 supply training, labeling, package design & pulmonary drug development. Overall responsibility for 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.
Consistently works on abstract problems across functional areas of the business. Identifies and evaluates fundamental issues, providing strategy and direction for major functional areas. Interacts internally and externally with executive level management requiring negotiation of extremely difficult matters to influence policymaking bodies. Oversees the development and management of Clinical Development Plans (CDP) which includes timelines, budget, and resource requirements. Ensures the development and implementation of clinical program strategy and directs those systems and programs in order to meet Company goals and objectives. Coordinates and directs outsourcing activities across program(s). Creates and directs program advisory committees as needed, such as Program Advisory Committee, DSMB and/or expert consultants. Identifies program/resource gaps; devises and implements solutions. Provides weekly enrollment and program updates to Senior Management. Drives project risk analysis and develops solutions to a variety of complex problems. Ensures that Clinical Operations department effectively interfaces with key functional groups. Remains current with medical developments and publications on similar and competitor products. Applies this knowledge to current programs. Mentors and develops Clinical Operations staff. Directs internal staffing and performance management, including hiring, training, coaching and performance reviews.
A Bachelors/Masters degree in a scientific discipline is required. A PhD in a scientific discipline is preferred. Equivalent experience may be accepted. A minimum of 15 years Pharmaceutical development experience moving product candidates from Phase I through pivotal, with at least 8 years managing CROs is required. A minimum of 12 years previous management experience may be required. Must have a demonstrated ability to solve problems with innovative solutions along with strong organizational skills. Excellent written and verbal communication skills are required. Previous experience working with senior management is 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.
Valid Through: 2019-9-20