Director, Clinical Pharmacology - Pediatric Virology
Full Time
Dublin, County Dublin
Posted
Job description
Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.
For Current Gilead Employees and Contractors:
Please log onto your
Internal Career Site
to apply for this job.
Job Description
Director, Clinical Pharmacology - Pediatric Virology
As a Director within the Clinical Pharmacology Group at Gilead, you will have 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 with a focus on pediatric development. 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.
Responsibilities:
- 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 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 and Experience:
- Thurough experience and a PhD, PharmD or MD degree with emphasis in clinical/quantitative pharmacology, pharmacokinetics or a related scientific discipline
- In-depth knowledge of pharmacokinetic and other analysis software programs (eg. WinNonlin, NONMEM, S-Plus/R, 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
Gilead Core Values
- INTEGRITY – Doing What’s Right
- INCLUSION – Encouraging Diversity
- TEAMWORK – Working Together
- EXCELLENCE – Being Your Best
- ACCOUNTABILITY – Taking Personal Responsibility
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and Contractors:
Please log onto your
Internal Career Site
to apply for this job.
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