Assoc Director/ Director Clinic Pharmacy Services

Submission for the position: Assoc Director/ Director Clinic Pharmacy Services - (Job Number: 185321)

Summarized Purpose:

Provides strategic direction and oversight of Pharmacy Servicesin-patient clinical research unit. Proactively collaborates in the development, implementation, and maintenance of appropriate policies, procedures and systems to ensure compliance with all regulatorybodies governing the pharmacy and research. Represents the departmentin clinic team meetings, sponsor meetings, audits and client consultationwith the goal of efficient, accurate drug accountability, dose administration, and complete documentationof all processes needed to accomplishthis goal.

Essential Functions: Supervises staff to include training, developmentand performance assessment.Analyzes the performance of the Pharmacyin terms of cost effectiveness and productivity. Establishes, approves and maintains Pharmacy procedures and policies to support managementoperationguidelinesrelated to investigational drugs and their administrationto study volunteers. Ensures adherence to all FDA regulations, state and federal laws and maintains documentationof such. Provides consultationto clients concerning future studies as it relates to pharmacy procedures and drug preparationand/or equipmentfor drug delivery. Provides pharmacydepartmental and supply costs for prospective studies/assist with study feasibility from a pharmacy perspective. Establishes a positive working relationship betweenthe pharmacy department and all other departments,teams and project managersto ensure a total environmentof teamworkthroughoutthe course of a trial. Participates in planning and implementationof automationmodules as it relates to the pharmacy and dosing of investigational drugs to study volunteers. Establishes operating policies & procedures that affect departments and subordinate sections of work units. Interprets company-wide policies and procedures. Develops budgets, schedules, and performance standards. Interacts frequently with internal and external managementand senior-level customer representatives concerning projects, operational decisions, scheduling requirements, and / or contractual clarifications. Leads briefings and technical meetings for internal and external representatives.

Management Role: Directs through lower management levels and / or highly skilled specialistemployees who exercise significantlatitude and independent judgment. Often heads one or more departments or a large centralized staff function. In some instances may be responsible for a functional area (as determined by executive management) and not have subordinate supervisorsor employees. May manage employees across multiple regions.

Summarized Purpose:

Provides strategic direction and oversight of Pharmacy Servicesin-patient clinical research unit. Proactively collaborates in the development, implementation, and maintenance of appropriate policies, procedures and systems to ensure compliance with all regulatorybodies governing the pharmacy and research. Represents the departmentin clinic team meetings, sponsor meetings, audits and client consultationwith the goal of efficient, accurate drug accountability, dose administration, and complete documentationof all processes needed to accomplishthis goal.

Essential Functions: Supervises staff to include training, developmentand performance assessment.Analyzes the performance of the Pharmacyin terms of cost effectiveness and productivity. Establishes, approves and maintains Pharmacy procedures and policies to support managementoperationguidelinesrelated to investigational drugs and their administrationto study volunteers. Ensures adherence to all FDA regulations, state and federal laws and maintains documentationof such. Provides consultationto clients concerning future studies as it relates to pharmacy procedures and drug preparationand/or equipmentfor drug delivery. Provides pharmacydepartmental and supply costs for prospective studies/assist with study feasibility from a pharmacy perspective. Establishes a positive working relationship betweenthe pharmacy department and all other departments,teams and project managersto ensure a total environmentof teamworkthroughoutthe course of a trial. Participates in planning and implementationof automationmodules as it relates to the pharmacy and dosing of investigational drugs to study volunteers. Establishes operating policies & procedures that affect departments and subordinate sections of work units. Interprets company-wide policies and procedures. Develops budgets, schedules, and performance standards. Interacts frequently with internal and external managementand senior-level customer representatives concerning projects, operational decisions, scheduling requirements, and / or contractual clarifications. Leads briefings and technical meetings for internal and external representatives.

Management Role: Directs through lower management levels and / or highly skilled specialistemployees who exercise significantlatitude and independent judgment. Often heads one or more departments or a large centralized staff function. In some instances may be responsible for a functional area (as determined by executive management) and not have subordinate supervisorsor employees. May manage employees across multiple regions.

Educationand Experience: BS in Pharmacy required Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10-12 years as a licensed pharmacist). 5 years of managementresponsibility in a pharmacy setting to include 1-2 years experiencein pharmaceutical research.

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities: Expert pharmaceutical knowledge Excellent knowledge of GCP’s, FDA, DEA regulations and guidelines as they apply to the dispensation of investigational drugs in a clinical researchenvironment Excellent knowledge of radiationsafety regulations as they apply to the preparationand administrationof radioactive substances in a clinical researchenvironment Proficiency with microsoftoffice Excellent verbal and written communicationskills Demonstrated strong leadership skills Excellentjudgmentand decisionmaking skills Excellentinterpersonal skills and problem solving ability Effective organizationand negotiationskills Ability to multi-task

Working Conditions and Environment: Work is performed in an office environment with exposure to electrical office equipment. 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 Long and variable work hours to include early mornings and weekends Occasionaltravel both domestic and international.

Physical Requirements: Frequently stationary for 6-8 hours per day. Exposure to various Investigational Products including radio-labeled compounds. Repetitive hand movementof both hands with the ability to make fast, simple, repeatedmovements of the fingers, hands, and wrists. Extended periods of standing, walking and sitting. Occasional crouching, stooping, bending and twisting of upper body and neck. Light to moderate lifting and carrying of objects up to 25 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Ability to communicate complex informationand ideas so others will understand; with the ability to listen to and understand informationand ideas presented throughspoken words and sentences. Frequently interacts with others,relates sensitive informationto 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. PPD is an equal opportunity employer, M/F/D/V – embracing diversity and the responsibilities of corporate citizenship in our communities. PPD values our former military and transitioning service member’s service.

Educationand Experience: BS in Pharmacy required Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10-12 years as a licensed pharmacist). 5 years of managementresponsibility in a pharmacy setting to include 1-2 years experiencein pharmaceutical research.

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities: Expert pharmaceutical knowledge Excellent knowledge of GCP’s, FDA, DEA regulations and guidelines as they apply to the dispensation of investigational drugs in a clinical researchenvironment Excellent knowledge of radiationsafety regulations as they apply to the preparationand administrationof radioactive substances in a clinical researchenvironment Proficiency with microsoftoffice Excellent verbal and written communicationskills Demonstrated strong leadership skills Excellentjudgmentand decisionmaking skills Excellentinterpersonal skills and problem solving ability Effective organizationand negotiationskills Ability to multi-task

Working Conditions and Environment: Work is performed in an office environment with exposure to electrical office equipment. 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 Long and variable work hours to include early mornings and weekends Occasionaltravel both domestic and international.

Physical Requirements: Frequently stationary for 6-8 hours per day. Exposure to various Investigational Products including radio-labeled compounds. Repetitive hand movementof both hands with the ability to make fast, simple, repeatedmovements of the fingers, hands, and wrists. Extended periods of standing, walking and sitting. Occasional crouching, stooping, bending and twisting of upper body and neck. Light to moderate lifting and carrying of objects up to 25 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Ability to communicate complex informationand ideas so others will understand; with the ability to listen to and understand informationand ideas presented throughspoken words and sentences. Frequently interacts with others,relates sensitive informationto 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. PPD is an equal opportunity employer, M/F/D/V – embracing diversity and the responsibilities of corporate citizenship in our communities. PPD values our former military and transitioning service member’s service. Submission for the position: Assoc Director/ Director Clinic Pharmacy Services - (Job Number: 185321)