VP Early Development
Summarized Purpose:
Provides leadership and oversight of Clinical Operations for the Phase I unit. Responsible for the overall management and performance of all areas relating to the Clinical Operations including Project Management, Clinical teams, Technical Operations, Paramedics, Flowcharting and Clinical Based Automated Data Capture Initiatives. Responsible for overseeing, coordinating, capturing and reporting the data for Phase 1 trials for PPD's major pharmaceutical and biotech clients.
Essential Functions and Other Job Information:
Oversees the daily clinical operation of Phase I Clinic and works closely with all divisional directors and managers to ensure client goals and timelines are achieved or exceeded.
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.
Ensures the scheduling of studies annually to achieve revenue goals.
Interacts with Business Development for scheduling purposes and to drive business into the unit. Travels to client companies for business development opportunities. Participates in industry conferences annually for the purpose of solidifying client relationships and bringing in new business.
Maintains client relationship to ensure client satisfaction, addresses quality and regulatory issues and provide Clinic information.
Leads the development and rollout of automation modules designed to streamline processes and enhance quality within the Phase 1Clinical setting.
Ensures revenue is tracked and reported accurately to Finance.
Works with Sr. Management team on an ongoing basis to develop and implement yearly business plan goals and objectives.
Qualifications:
Education and
Experience:
Bachelor's degree in scientific or related discipline and previous clinical research experience (comparable to 15 years) to include 5 years in Phase I. A visionary leader with at least 10 years of clinical operations management experience and a strong background in project coordination and regulatory experience.
Knowledge, Skills and Abilities:
Thorough knowledge of all aspects of the drug development process, specifically Phase I
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
Excellent verbal and written communication skills
Proficiency in Microsoft Office Tools
Ability to motivate large numbers of employees through stressful situations
Supervisory Responsibilities
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 and/or clinic environment with exposure to electrical office equipment
Occasional exposure to various investigational products including radio labeled products
Occasional exposure to infectious disease and biohazardous material
Frequently drives to site locations, frequently travels within the United States, occasional international travel with limited advance notice
Personal protective equipment may be required such as protective eyewear, garments and gloves
Working hours are long and varied including weekends and holidays
Nature of the business requires constant accessibility and feedback to staff and clients which often involves interaction with staff/clients verbally or by email after hours and on weekends
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 mult iple 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.
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
Provides leadership and oversight of Clinical Operations for the Phase I unit. Responsible for the overall management and performance of all areas relating to the Clinical Operations including Project Management, Clinical teams, Technical Operations, Paramedics, Flowcharting and Clinical Based Automated Data Capture Initiatives. Responsible for overseeing, coordinating, capturing and reporting the data for Phase 1 trials for PPD's major pharmaceutical and biotech clients.
Essential Functions and Other Job Information:
Oversees the daily clinical operation of Phase I Clinic and works closely with all divisional directors and managers to ensure client goals and timelines are achieved or exceeded.
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.
Ensures the scheduling of studies annually to achieve revenue goals.
Interacts with Business Development for scheduling purposes and to drive business into the unit. Travels to client companies for business development opportunities. Participates in industry conferences annually for the purpose of solidifying client relationships and bringing in new business.
Maintains client relationship to ensure client satisfaction, addresses quality and regulatory issues and provide Clinic information.
Leads the development and rollout of automation modules designed to streamline processes and enhance quality within the Phase 1Clinical setting.
Ensures revenue is tracked and reported accurately to Finance.
Works with Sr. Management team on an ongoing basis to develop and implement yearly business plan goals and objectives.
Qualifications:
Education and
Experience:
Bachelor's degree in scientific or related discipline and previous clinical research experience (comparable to 15 years) to include 5 years in Phase I. A visionary leader with at least 10 years of clinical operations management experience and a strong background in project coordination and regulatory experience.
Knowledge, Skills and Abilities:
Thorough knowledge of all aspects of the drug development process, specifically Phase I
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
Excellent verbal and written communication skills
Proficiency in Microsoft Office Tools
Ability to motivate large numbers of employees through stressful situations
Supervisory Responsibilities
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 and/or clinic environment with exposure to electrical office equipment
Occasional exposure to various investigational products including radio labeled products
Occasional exposure to infectious disease and biohazardous material
Frequently drives to site locations, frequently travels within the United States, occasional international travel with limited advance notice
Personal protective equipment may be required such as protective eyewear, garments and gloves
Working hours are long and varied including weekends and holidays
Nature of the business requires constant accessibility and feedback to staff and clients which often involves interaction with staff/clients verbally or by email after hours and on weekends
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 mult iple 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.
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
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