Director Clinic Operations - Phase I

Summarized Purpose: Establishes, implements and assesses department goal achievement while managing the day-to-day activities of the clinical and technical operations staff in the Phase I clinic. Responsible for logistical, operational and strategic planning for all projects being conducted in the Phase I unit. Essential Functions and Other Job Information: Plans for the appropriate study conduct and staffing logistics to ensure a successful weekly workflow (including volunteer recruitment, clinical conduction, and client deliverables). Assures appropriate and adequate staffing of the CRU. Attends regular standing meetings and key sponsor initiation meetings. Schedules operational and study meetings as needed. Communicates with client representatives on a regular basis to gain feedback. Participates in meetings with senior management to provide updates, receive feedback, discuss strategic business plans, etc. Initiates and participates in weekly meetings with each department manager detailing the workload ahead and determining future needs. Participates in and leads work teams in automation to further give PPD a competitive advantage utilizing these technological advances. Occassionally participates in weekend coverage as it relates to management oversight of the CRU and is available for client dinners and entertainment opportunities as needed. Travels to client companies for business development opportunities. Participates and represents PPD in 1-2 industry conferences per year for the purpose of solidifying client relationships and bringing in new business. Interacts with Business Development for scheduling purposes and to drive business into the unit. Establishes policies appropriate for the function. Interprets and recommends modifications to company-wide policies and practices and implements such recommendations. Develops and is responsible for budgets, schedules, and performance standards.

#PPDLABS

#LI-33456501_TG1 Summarized Purpose: Establishes, implements and assesses department goal achievement while managing the day-to-day activities of the clinical and technical operations staff in the Phase I clinic. Responsible for logistical, operational and strategic planning for all projects being conducted in the Phase I unit. Essential Functions and Other Job Information: Plans for the appropriate study conduct and staffing logistics to ensure a successful weekly workflow (including volunteer recruitment, clinical conduction, and client deliverables). Assures appropriate and adequate staffing of the CRU. Attends regular standing meetings and key sponsor initiation meetings. Schedules operational and study meetings as needed. Communicates with client representatives on a regular basis to gain feedback. Participates in meetings with senior management to provide updates, receive feedback, discuss strategic business plans, etc. Initiates and participates in weekly meetings with each department manager detailing the workload ahead and determining future needs. Participates in and leads work teams in automation to further give PPD a competitive advantage utilizing these technological advances. Occassionally participates in weekend coverage as it relates to management oversight of the CRU and is available for client dinners and entertainment opportunities as needed. Travels to client companies for business development opportunities. Participates and represents PPD in 1-2 industry conferences per year for the purpose of solidifying client relationships and bringing in new business. Interacts with Business Development for scheduling purposes and to drive business into the unit. Establishes policies appropriate for the function. Interprets and recommends modifications to company-wide policies and practices and implements such recommendations. Develops and is responsible for budgets, schedules, and performance standards.

#PPDLABS

#LI-33456501_TG1 Qualifications: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12 years) or equivalent and relevant combination of education, training, & experience. Strong background in project management, regulatory, FDA, and ICH guidelines 5 years of management responsibility Strong leadership skills Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions. Knowledge, Skills and Abilities: Extensive knowledge of clinical trials Ability to drive and adjust departmental day to day activities to effectively conduct clinical trials Excellent verbal and written communication skills Attention to detail and ability to multitask Knowledge of Microsoft Office software Strong leadership skills and critical thinking skills Excellent organizational skills Effective time management and project management skills Ability to lead and facilitate cross functional teams successfully Ability to act as a liaison with the client, investigator, study team and other departments Management Role: Directs through lower management levels. Has responsibility for managing a function that includes multiple related departments. 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 travels 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. Qualifications: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12 years) or equivalent and relevant combination of education, training, & experience. Strong background in project management, regulatory, FDA, and ICH guidelines 5 years of management responsibility Strong leadership skills Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions. Knowledge, Skills and Abilities: Extensive knowledge of clinical trials Ability to drive and adjust departmental day to day activities to effectively conduct clinical trials Excellent verbal and written communication skills Attention to detail and ability to multitask Knowledge of Microsoft Office software Strong leadership skills and critical thinking skills Excellent organizational skills Effective time management and project management skills Ability to lead and facilitate cross functional teams successfully Ability to act as a liaison with the client, investigator, study team and other departments Management Role: Directs through lower management levels. Has responsibility for managing a function that includes multiple related departments. 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 travels 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.