Clinical associate Jobs in Chicago il

Position Overview :

Have you got the right qualifications and skills for this job Find out below, and hit apply to be considered.

The role is responsible for leading and managing the design and execution of comprehensive Clinical Pharmacology strategies to meet both commercial and regulatory objectives across multiple functions. This individual will drive the development of pharmacokinetics (PK) and pharmacodynamics (PD) studies, generate new study proposals, and lead the implementation of these strategies. They will also proactively assess advances in clinical pharmacology, PK / PD, and regulatory requirements, identifying strengths, weaknesses, and opportunities, and adjusting strategies as needed. The role ensures alignment between scientific and business objectives, managing clinical pharmacology aspects of various projects.

Key Responsibilities :

• Oversee the design and strategy of Phase 1-4 clinical studies, serving as the primary representative for the project(s).
• Lead the execution of strategies, guide teams, and provide contextual data analysis and interpretation, including the explanation of mechanisms of action (MoA) and disease-specific data, and discussion of model results in the context of research objectives.
• Write regulatory documents such as protocols, study reports, population PK reports, exposure-response analysis reports, clinical trial applications (CTAs), and sections for investigator brochures and white papers.
• Lead clinical pharmacology and biopharmaceutics meetings and serve as the Clinical Pharmacology representative in cross-functional teams, such as Clinical Strategy Teams and Asset Development Teams.
• Direct small, cross-functional teams to present a unified clinical pharmacology stance to clinical, CMC, and regulatory teams.
• Publish scientific papers and present findings at national and international conferences, interacting with key opinion leaders (KOLs) and other external stakeholders.
• Conduct due diligence for potential business opportunities, summarizing findings and representing Clinical Pharmacology in business development teams.
• Act as the Clinical Pharmacology lead in regulatory meetings, representing the team and driving discussions.

Qualifications :

Drive business results while positioning the organization for long-term success.

J-18808-Ljbffr