About the job

At ICON Strategic Solutions, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.

That's our vision. We're driven by it. And we need talented people who share it.

If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.

As member of Quantitative Clinical Pharmacology and Pharmacometrics (QCP²), the Director, Pharmacology will support aspects of clinical pharmacology and responsible for supervising and conducting population PK/PD modeling and simulation activities with emphasis on both early and late-phase drug development.

What you will be doing:

Develop and execute 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.

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.

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.

Support product development by defining dose-concentration-pharmacological effect relationships of a drug using modeling & simulation methodologies from data acquired at various development stages (Phase 1-3).

Develop and review study designs, write analysis plans & reports, analyse and interpret PK/PD data and results.

Devise and implement strategy for ensuring an integrated approach for the utilization of expertise through close partnership with preclinical, clinical, and regulatory.

Identify opportunities and ways to address drug development questions/issues.

Coordinate of clinical pharmacology/pharmacometrics related outsourced activities.

You are:

A PhD graduated in Biological Sciences, Bioengineering or a related field with 15+ years of experience in pharmaceutical or related fields.

Fluent in written and spoken English with strong communication skills.

Self motivated with the ability to work independently with minimal supervision (personal accountability).

Good in 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.

Able to multi-task and prioritize assignments, establishing courses of action for self and others to ensure that work is completed efficiently and in a timely manner (planning, organizing and time management).

Able 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