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Director of Clinical Pharmacology (Infectious Diseases)
Reference: | KS/AAFG-735470 | Location: |
Dublin |
Qualification: | Doctorate | Experience: | 10+ Years |
Job Type: | Permanent | Salary: | Not Disclosed |
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
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]
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