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Job Details

PPD Consultant (Director, Senior Director or Executive Director)-143115

Company: PPD
Location: Europe, Middle East & Africa
Reference: 143115
Closing Date: 22 Dec 17
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

We have a vacancy in EMEA in the PPD Consulting team. This can be either office or home based in the EMEA region where PPD has a base.This role promotes PPD business capabilities in a specified area of focus (non-clinical pharmacology/toxicology, CMC, etc.) from early stage to post-marketing to advance external visibility of PPD and expand the base of clients. Drives strategy to advance PPD business goals and proactively address changing regulatory environment for drug development programs. ...

Requirements:

We have a vacancy in EMEA in the PPD Consulting team. This can be either office or home based in the EMEA region where PPD has a base.


This role promotes PPD business capabilities in a specified area of focus (non-clinical pharmacology/toxicology, CMC, etc.) from early stage to post-marketing to advance external visibility of PPD and expand the base of clients. Drives strategy to advance PPD business goals and proactively address changing regulatory environment for drug development programs.

 

Essential Functions:

  • 30% - Creates and coordinates strategic planning and execution activities in building winning strategic relationships; identifies opportunities/gaps in sponsor programs, to advance greater awareness of PPD capabilities to potential clients
  • 30% - Advances visibility of full ranges of PPD capabilities to client community through targeted outreach in conferences, meetings, presentations and other appropriate settings
  • 20% - Assists Business Development in obtaining new partnership agreements and expanding opportunities with current partners
  • 10% - Assists executives in developing key alliance strategies incorporating non-clinical and regulatory recommendations into proposal strategies
  • 10% - Delivers client services (utilization rate)
  • Develops solutions to highly complex and unique issues that impact and address future concepts, products or technologies.
  • As an expert in the field, uses professional concepts in developing resolution to critical issues and broad design matters. Normally requires nomination and top management review and approval at this level.
  • Exercises wide latitude in determining objectives and approaches to critical assignments.
  • Complete latitude for independent judgment in methods, techniques and evaluation criteria for obtaining results.
  • Serves as a consultant and spokesperson for the functional area or as an external spokesperson for the organization on highly significant matters.
  • Creates formal networks with key decision makers.


Qualifications

Education and Experience: 


Pharm D., M.D. or Ph.D. in a scientific discipline or related field required.  Some positions may require a Ph.D. in s specified field (i.e., Toxicology, Pharmacology, Chemistry, Pharmaceutics, Bioprocess engineering, etc.)


Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 15 years of experience working in the biotech/pharmaceutical industry) or equivalent combination of education, training, & experience. Some positions may require several years of drug development experience in a range of therapeutic areas, including experience with non-clinical, clinical drug development and understanding of regulatory environment. 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:

  • Thorough understanding of overall biologic/ pharmaceutical product development process, from pre-IND through post-marketing, including all stages of development and all functional roles
  • Ability to work effectively in advancing PPD business as part of teams across all relevant PPD business units and subsidiaries in external settings for conferences, seminars and with regulatory agency policy meetings.
  • Working knowledge of the biological sciences with technical, scientific or medical expertise in one or more functional areas involved in pharmaceutical/biologic product development
  • Thorough understanding of core cross-functional concepts (e.g., preclinical, translational medicine, CMC) and major requirements at different development stages
  • Basic knowledge of worldwide regulatory requirements, processes and regulatory authority interactions, as well as patent protection and records management
  • Knowledge of commercial valuation, product life cycle planning, pricing and health economics
  • Effective organizational, planning and negotiation skills
  • Proven ability to work effectively in a team environment
  • Effective oral and written communications skills
  • Ability to act as a liaison with other departments where necessary
  • Strong interpersonal skills with the ability to build strong working relationships and manage internal and external stakeholders
  • Ability to work independently on multiple tasks in a fast-paced environment
  • Strong decision-making and analytical skills
  • May require strong working knowledge of US FDA and EMA requirements and policies
  • May require the ability to monitor regulatory policy developments and to develop analysis and strategy for responding when relevant to PPD clients’
  • May require proven regulatory success and track record in obtaining product approvals

Apply for this job: PPD Consultant (Director, Senior Director or Executive Director)-143115

Contact Information:

Address:  PPD Cambridge
Granta Park
Great Abington
Cambridge

CB21 6GQ
England
Website:  Visit Our Web Site

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