Therapeutic Area Lead - Director - Late Stage Trials



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An exciting opportunity for a Director/Senior Director to become a Therapeutic Area Lead for Late Stage Research and to help develop and drive strategies to achieve annual growth plans in phase IIIB/IV, including working with strategic leaders within business development and medical to develop targeted plans to extend core business trials into lifecycle awards. . 


The successful candidate will be responsible for the development of late stage project management teams and the acquisition of late stage projects within an assigned therapeutic area.  He/She will work with leadership across all  functional areas on the development and refinement of late-stage specific business processes in order to improve market competitiveness.    Serving as a liaison with Business Development, Strategy Directors and Operational Leads to drive strategically differentiating proposals, bid defenses, and client presentations. Assisting global therapeutic area heads in resource utilization, policy development, and implementation of goals to progress late stage operations. 


Does not hold direct line management or project oversight responsibilities. 


Candidates considered in North America will have the option to be office or home based. 

Education and Experience: 
·       Bachelor's degree or licensed certified health care training or equivalent combination of education and experience that provides the individual with the required knowledge, skills and abilities.
·       A demonstrated track record of success in clinical development.
·       Ten years or more of work experience in Late Stage of which at least 5 years or more in observational research.
·       Proven experience developing budgets and high quality proposals and bid defense strategies in observational research and interventional Ph IV trials  
·       Demonstrated experience building and maintaining client relationships
·       Experience using project management software.
·       or equivalent combination of education and experience that provides the individual with the required knowledge, skills and abilities.
·       Valid Passport, where appropriate.
Candidates who are currently functioning in a Director Level capacity are strongly preferred.
Knowledge, Skills and Abilities:
·         Strong business development acumen and presentation skills
·         Strong financial acumen and business planning skills
·         Strong leadership skills.
·         A strategic thinker capable of developing plans aligning to client goals and regulatory/marketing objectives for late stage research  
·         Knowledge of regional/global regulatory guidelines/directives especially around late stage research.
·         Strong background in observational research.
·         Skilled in process improvement, especially as it applies to Phase IIIb/IV trials and non-interventional research.
·         Expert knowledge of the late stage operations and associated project execution strategies.
·         Knowledge of other functions involved in late stage research such as Epidemiology, Health Outcomes, Health Economy and Pregnancy Registries.
·         Excellent judgment and decision making skills.
·         Effective oral and written communication skills
·         Excellent interpersonal skills and problem solving ability
·         Effective organizational skills and negotiation skills.
·         Expert knowledge of project management principles and application.
·         Knowledge of budgeting, forecasting and resource management.
·         A relationship builder who is able to work effectively in matrix organizations.
·         Computer skills.
PPD is an Equal Opportunity Employer
Additional Information
Location | North Carolina | | Morrisville Start Date 2013-07-09
Job Type Full Time
Salary Not Provided
Career Level Not Provided Relevant Work Experience Not Provided
Education Level Not Provided Job posted on 09-Jul-2013

Contact Information
Company Name Pharmaceutical Product Development Telephone No Not Provided
Contact Name Site Link Not Provided


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