Senior Clinical Pharmacologist (Home based across EMEA)

Working in ICON Strategic Solutions is more than a job, it’s a calling for people who care and have passion for improving patients’ lives. It takes courage to move from one job to another and the process involves careful consideration. At ICON, we care about our people as they are the key to our success and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term career.

All our team members have the independence to get the job done with support from the experienced leadership team when you need it. If you want a career with a difference, ICON Strategic Solutions is the place for you.

As member of Quantitative Clinical Pharmacology and Pharmacometrics (QCP²), the Senior Clinical Pharmacologist will support all aspects of clinical pharmacology, biopharmaceutics and model-based drug development with emphasis on both early and late-phase drug development.

What will you be doing?

You will be responsible for completion of the following:

• Developing and executing CP 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.

You are:

• A PhD in Biological Sciences, Bioengineering or a related field with 15+ 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 with strong biologics background, 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

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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