Associate Director, Clinical Pharmacology

Company: Pharmaceutical Research Associates, Inc
Location: Wilmington
Posted on: March 20, 2025

Job Description:

OverviewAs an Associate Director within the Clinical Pharmacology Group, you will have ultimate responsibility and accountability for clinical pharmacology programs.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.ResponsibilitiesWhat 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 relationships with colleagues within and outside the department.
• Authoring/reviewing/approving clinical 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 ensure 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.QualificationsYou are:
  • PharmD or MD degree with emphasis in clinical pharmacology, pharmacokinetics, or a related scientific discipline.
  • 10+ years of relevant experience in a similar role.
  • Excellent written and oral communication skills and ability to convey complex technical information clearly.
  • Confidence and ability to present to and influence senior leaders.
  • Ability to critically analyze problems and provide creative solutions.
  • Confidence and discipline to work autonomously.
  • Genuine curiosity and drive to ask questions - looking for the 'why' of every project.
  • Desire to strive for continuous improvement.What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits designed to be competitive within each country and focused on well-being and work-life balance opportunities for you and your family. Our benefits examples include:
    • Various annual leave entitlements.
    • A range of health insurance offerings to suit you and your family's needs.
    • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
    • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
    • Life assurance.
    • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.Visit our careers website to read more about the benefits of working at ICON: At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organization. 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. 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 through the form below. 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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Keywords: Pharmaceutical Research Associates, Inc, Wilmington , Associate Director, Clinical Pharmacology, Executive , Wilmington, Delaware