Provides leadership and global oversight of operations for Site Intelligence and Activation (SIA) services. Responsible for development of the infrastructure to support advanced clinical trials, as well as strategy formulation and implementation for regulatory processes to ensure delivery of best-in-class SIA services. Creates a high performance culture through leadership, coaching and development to achieve delivery of SIA service targets/measures (e.g. cost, quality, time). Ensures alignment and integration of all SIA services to drive operational excellence, improve cycle times and rapid site activation.
Essential Functions Provides leadership through effective staffing, performance management and development. Develops the infrastructure, systems, processes and policies to effectively deliver innovative and customized solutions to meet clients' needs. Drives operational excellence to achieve SIA service targets, performance metrics and financial targets. Leverages data driven planning to ensure full integration of SIA services that support successful operations and site activation. Develops and fosters mutally beneficial relationships with internal and external stakeholders to assist in winning new business and execution of existing business. Champions process improvements and promotes compliance with industry standards and regulations.QualificationsQualifications:
Education and Experience:
Bachelor's degree in scientific or related discipline and previous clinical drug development experience (comparable to 15 years) in a CRO or Pharmaceutical industry. A visionary leader with at least 10 years of clinical operations management experience. Must have experience with site identification, patient enrollment and/or study start-up tasks including legal and investigator payments.
Knowledge, Skills and Abilities: Advanced leadership skills and executive presence Proven negotation skills and ability to effectively influence executives and other stakeholders Exceptional business acumen with comprehensive understanding of the organization and functional areas Ability to work in a high pressure/time sensitive environment including the ability to handle multiple issues on multiple projects simultaneously Advanced knowledge of strategic planning, budgeting, forecasting and fiscal management Strong organizational agility and demonstrated drive for results Track record of building peer relationships and effective teams with demonstrated global and cultural awareness Expertise motivating and integrating teams, as well as excellent coaching and mentoring skills Analytical skills, excellence in oral and written communications, strong attention to detail, priorization and time management proficiencies Thorough understanding of sponsor/CRO business practices and strong knowledge of PPD operational/financial practices, SOPs, GCPs and FDA/ICH guidelines with the ability to analyze and evaluate processes and proceduresManagement Role:
Manager role with significantly larger management scope (e.g. global or regional responsibilities or multiple departments) OR mastery of manager skills and responsibilities as demonstrated by consistent, multi-year successful performance. In some instances may be responsible for a functional area (as determined by executive management) and not have subordinate supervisors or employees.
Working Conditions and Environment Work is performed in an office environment with exposure to electrical office equipment. Occasional drives to site locations, frequent travel both domestic and international.Physical Requirements: Frequently stationary for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Moderate mobility required. Occasional crouching, stooping, bending and twisting of upper body and neck. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Ability to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others, relates sensitive information to diverse groups both internally & externally. Ability to apply abstract principles to solve complex conceptual issues. Requires multiple periods of intense concentration. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Regular and consistent attendance.Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.