Our client is a leading Bio-Pharma who are establishing a new office in Dublin in the area of Clinical Research, with specific focus on Pediatric Trials. 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

• 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