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Director, Clinical Pharmacology - Wilmington, Delaware

7+ years
Not Disclosed
10 Oct. 3, 2024
Job Description
Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Overview

As a Director within the Clinical Pharmacology Group, you will hold ultimate responsibility and accountability for clinical pharmacology programs, overseeing their development and execution.

Responsibilities

What You Will Be Doing:

As a key member of the Clinical Pharmacology team, you will have a unique opportunity to engage in all aspects of the product development process, from first-in-human trials to post-marketing activities. This role allows you to contribute to a wide range of products within and across your area of responsibility, fostering a fun and rewarding career while promoting continuous learning.

  • Provide strategic leadership and accountability for clinical pharmacology programs supporting Phase 1-4 clinical development of compounds.
  • Serve as a subject matter expert, representing the department on cross-functional project teams.
  • Cultivate and maintain collaborative relationships with colleagues both within and outside the department.
  • Author, review, and approve clinical protocols, analysis plans, study reports, and regulatory submissions.
  • Develop high-quality clinical pharmacology plans and content for global regulatory submissions, including INDs, IBs, NDAs, MAAs, and pediatric plans.
  • Execute Clinical Pharmacology studies in close collaboration with Clinical Operations.
  • Evaluate departmental and organizational SOPs for compliance with current scientific standards and regulatory requirements.
  • Ensure adherence to timelines and budgets for prompt and accurate execution of deliverables from clinical pharmacology studies and programs.
  • Participate in and collaborate on special projects across the organization.

Qualifications

You Are:

  • Possessing at least 5 years of experience with a PhD, PharmD, or MD degree focused on clinical pharmacology, pharmacokinetics, or a related scientific discipline.
  • Equipped with excellent written and oral communication skills, capable of conveying complex technical information clearly.
  • Confident and able to present to and influence senior leaders.
  • Skilled at critically analyzing problems and providing creative solutions.
  • Disciplined and capable of working autonomously.
  • Genuinely curious, driven to ask questions, and eager to explore the 'why' behind every project.
  • Committed to continuous improvement.
  • Experienced in early-phase clinical development.

Location Requirement: Wilmington, DE area - Hybrid Home/Office Based

Why ICON?

At ICON, we aim to provide a comprehensive and competitive total rewards package that includes an attractive base salary along with a variety of variable pay and recognition programs. Our employee benefits, supportive policies, and well-being initiatives are designed to support you and your family throughout your career journey.

Our success relies on the knowledge, capabilities, and quality of our people, which is why we are dedicated to fostering a culture of continuous learning. We challenge you with engaging work where every experience contributes to your professional growth.

ICON and its subsidiaries are equal opportunity and inclusive employers committed to creating a workplace free from discrimination and harassment. All qualified applicants will receive equal consideration for employment, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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

Interested in the role but unsure if you meet all the requirements? We encourage you to apply anyway—there's a good chance you could be exactly what we’re looking for at ICON, whether for this position or others.

Employment Type: OTHER