Director, Clinical Pharmacology

Dublin (City), Leinster (IE)
17 Feb 2021
19 Mar 2021
Full Time
Contract Type
Experience Level

On Behalf of my client, we are assisting with the role of Director, Clinical Pharmacology.  As Director, within the Clinical Pharmacology Group you 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 you will 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. We seek to provide a fun and rewarding career and a continuous learning experience.

Your tasks and responsibilities will include;
•    Leading clinical pharmacology studies of the highest complexity
•    Providing strategic leadership and demonstrating accountability for the clinical pharmacology programs supporting Phase 1-4 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 paediatric 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

Specific education, experience and skills required for this role;
•    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 (e.g. 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 full details on this opportunity contact Tina at +353 1 12784671 or email 
Thornshaw Scientific is a division of the CPL group of companies.

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