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Job Details

Scientific Director

Company: PAREXEL
Location:
Reference: 39026BR
Closing Date: 30 Nov 17
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

The Quantitative Clinical Development Director will provide senior leadership to ensure the strategic application of Clinical Pharmacokinetic (PK), Pharmacodynamic (PD), and Modeling & Simulation (MS) principles towards efficient drug development.

Requirements:


The Quantitative Clinical Development Director will provide senior leadership to ensure the strategic application of Clinical Pharmacokinetic (PK), Pharmacodynamic (PD), and Modeling & Simulation (MS) principles towards efficient drug development.   Individuals will provide expert consultative support for PK/PD strategy and interpretation to other Business Units and clients.  The QCD Director will set the direction and delivery of quality services to clients and serve as points of contact to senior members of PAREXEL.


Key Accountabilities:

  • To analyze clinical PK/PD data as a member of several multidisciplinary development program teams.
  • To work with clinical team to design PK/PD components in various study designs such as first-in-human, bioequivalence and drug-drug interaction studies.
  • Responsible for authoring or contributing to clinical PK/PD sections of relevant documents.
  • Serve as a primary source of scientific support for the design, analysis, reporting, and presentation of sophisticated PK/PD modeling and simulation initiatives, including population PK/PD analyses for all phases of development.
  • Review of scientific documentation including Clinical Study Protocols, SOPs, Statistical Analysis Plans and Clinical Study Reports.
  • Provides Quality Control (QC) for WinNonlin and NONMEM analysis.
  • Review of derived PK/PD data generated by PK Analyst.
  • Maintaining a strong working knowledge of pharmacology, biology, therapeutics, drug metabolism, bioanalysis, and biopharmaceutics.
  • Developing and maintaining a relationship with internal and external clients and scientists.
  • Undertake the full range of duties relevant to the leadership, management and development of the team to ensure their performance meets and or exceeds both the business and their own personal goals/objectives.
  • Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner.
  • To provide training and scientific support and advice to relevant PAREXEL staff.
  • To attend client meetings and represent Quantitative Clinical Pharmacology aspects as needed.


Skills:

  • Excellent knowledge of PK and PD principles
  • Strong experience with the design and implementation of Model-Based Drug Development strategies
  • Expertise with Pharmacometric methodologies (e.g., disease modelling, conc-QT analysis, clinical trial simulation, etc)
  • Experience in Pharsight Software (PKS/WinNonlin/Phoenix)
  • Experience in other software such as NONMEM, GastroPlus and R is desirable
  • Relevant experience in clinical drug development of both NCEs and biologicals
  • Excellent interpersonal, verbal and written communication skills
  • Extensive clinical/scientific writing skills
  • Client focused approach to work ethic
  • A flexible attitude with respect to work assignments and new learning
  • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
  • Willingness to work in a matrix environment and to value and promote the importance of teamwork.
  • Demonstrated understanding of the drug development process and a broad knowledge of FDA and EMEA guidelines.


Education:

  • Advanced science degree (PhD, PharmD) and/or relevant experience

Apply for this job: Scientific Director

Contact Information:

Address:  PAREXEL International
The Quays
101-105 Oxford Road
Uxbridge
Middlesex
UB8 1LZ
England
Tel:  +44 1895 238000
Fax:  +44 1895 238494
Website:  Visit Our Web Site
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