I'm looking for...
close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome
IE
Internet Explorer
firefox
Mozilla Firefox
opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Contact Info
Karen Shiel
Life Science

+353 1 5079256
[email protected]
Connect with me on
Quality Engineer
Limerick
Risk Manager
Dublin
Process Engineer
Limerick
R&D Engineer
Galway
GMP Inspector
Dublin
Regulatory Affairs Specialist
Republic of Ireland
VP of R&D
Galway
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

Current Location:

Notice Period:

Write here your cover note:


If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to [email protected]
Details

Director of Clinical Pharmacology (Infectious Diseases)


Reference:KS/AAFG-735470 Location: Dublin
Qualification:DoctorateExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed

Our client is a leading Bio-Pharma who are establishing a new office in Dublin in the area of Clinical Research. As a Director within the Clinical Pharmacology Group, the successful person will have ultimate responsibility and accountability for clinical pharmacology programs in the area of HIV and emerging viral infections. As a member of the Clinical Pharmacology team this person shall have unparalleled opportunity to be involved with every aspect of the product development process, from first-in human through approval, including post-marketing activities. In this role, you will have the advantage of providing input into a breadth of products within and across your area of responsibility.

Role/Responsibilities:

  • Leading clinical pharmacology studies of the highest complexity
  • Providing strategic leadership and demonstrating accountability for the clinical pharmacology programs supporting Phase I-IV clinical development for development compounds in your therapeutic area(s)
  • Developing and implementing new clinical pharmacology tools and technologies to drive smarter drug development for programs.
  • Representing the department and providing subject matter expertise on cross-functional project teams
  • Developing and maintaining collaborative working relationship with colleagues within and outside the department
  • Supervising, developing and mentoring junior level scientists, both direct reports and via matrix structure in clinical pharmacology teams
  • Authoring/reviewing/approving clinical protocols, analysis plans, study reports and regulatory submissions
  • Developing high quality clinical pharmacology plans and content for global regulatory submissions, including INDs, IBs, NDAs, MAAs and pediatric plans
  • Maintaining and establishing relationships and agreements with contract vendors
  • Evaluating departmental and broader organizational SOPs as fit for purpose, in compliance with current scientific standards and regulatory requirements
  • Ensuring adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs
  • Understanding the impact of decisions and actions on the business and consulting with colleagues and management as applicable
  • Participating in and collaborating with individuals from across the business in special projects
  • Developing and presenting training within and outside the department

Education/Experience:

  • Extensive experience and a, PhD, PharmD or MD degree with emphasis in clinical pharmacology, pharmacokinetics or a related scientific discipline
  • In-depth knowledge of pharmacokinetic and other analysis software programs (eg. WinNonlin, GraphPad , etc.)
  • Thorough knowledge of current and emerging scientific standards regulatory requirements for assigned territories
  • Excellent written and oral communication skills and ability to convey complex technical information clearly
  • Confidence and ability to present to and influence senior leaders
  • Ability to critically analyze problems and provide creative solutions
  • Confidence and discipline to work autonomously
  • Genuine curiosity and drive to ask questions – looking for the ‘why’ of every project
  • Desire to strive for continuous improvement

For a confidential discussion plesae contact Karen Shiel on 087 7452487 or send CV to [email protected]