Senior Clinical Pharmacologist

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Senior Clinical Pharmacologist - Fixed Term min - 12 months

(Director, Clinical Pharmacology)

We are currently seeking a Director, Clinical Pharmacology to join our diverse and dynamic team. As a Director, Clinical Pharmacology at ICON, you will play a pivotal role in leading the design, execution, and interpretation of clinical pharmacology studies to support the development of innovative therapies. You will ensure the strategic integration of pharmacokinetic and pharmacodynamic data into clinical trial designs, driving informed decision-making and advancing therapeutic development.

What You Will Be Doing:

-Developing and executing development strategy in supporting the selection of the right dose-regimen, in the right population, using the relevant biomarkers and the right endpoint to achieve differentiation and develop a CP package that enables global product registration.
- Design and execution of appropriate modeling plans along with the Pharmacometrician assigned to the project.
-Contribute to the design and planning of pre-clinical studies to inform translational modeling.
-Contribute to the design and dose selection of the FIH study (SAD,MAD).
-Contribute to the required components of regulatory submissions and be responsible for responding to regulatory authority queries.
- Will drive early alignment on key development questions where CP principles could be applied.
-Actively participate in project discussions with project teams to understand the scope and need for QCP² involvement and develop appropriate plans that address the key development questions.
-Attend governance meetings, as necessary, ensure that CP plans are flawlessly executed, on time for efficient decision making.
-Keep up-to-date knowledge of model-based drug development with focus on Clinical pharmacology, biopharmaceutics, PKPD & other related analytical sciences including implementation of innovative methods to preclinical research, translational sciences and clinical development.
-Devising and implementing strategy for ensuring an integrated approach for the utilization of expertise through close partnership with preclinical, clinical, and regulatory.
-Coordination of clinical pharmacology related outsourced activities.
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Your Profile:

· A PhD in Biological Sciences, Bioengineering or a related field with at least 13 years of experience in pharmaceutical or related fields.
- Fluent in written and spoken English 
- Good written and oral communication skills
-Knowledge and understanding of innovative approaches in clinical pharmacokinetics, clinical pharmacology, PK and PK-PD modeling approaches and their applications in model based drug development
-A thorough knowledge of the clinical development process
-Ability to drive alignment around his/her vision and strategy across departments 

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What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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