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Director, Clinical Pharmacology

2 months ago

Wilmington, United States ICON Strategic Solutions Full time

As a Director within the Clinical Pharmacology Group, you will have ultimate responsibility and accountability for clinical pharmacology programs.

What you will be doing:

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. 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.

What you will be doing:

  • Providing strategic leadership and demonstrating accountability for the clinical pharmacology programs supporting Phase 1-4 clinical development for development compounds
  • 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
  • Authoring/reviewing/approving clinical oncology 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
  • Execution of Clinical Pharmacology studies in close collaboration with Clinical Operations
  • 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
  • Participating in and collaborating with individuals from across the business in special projects

You are:

  • Required education is PhD, PharmD or MD degree with emphasis in clinical pharmacology, pharmacokinetics or a related scientific discipline
  • Required experience is a minimum of 5 years with responsibility and accountability for clinical pharmacology programs within a CRO/Pharma or Biotech
  • Required experience authoring/reviewing/approving clinical protocols within Oncology
  • Early phase 1 and phase 2 experience in Oncology is required
  • Location requirement: Wilmington DE area - Hybrid Home/Office Based (2 days/week)

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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