Report this job

---

What is the problem? *

Incorrect company
Incorrect location
Job is expired
Job may be a scam
Other

The Associate Director / Director of Clinical Program Management will provide comprehensive support to the Clinical Development Team in planning and achieving corporate development objectives. This position holds significant responsibility in assisting the clinical development team throughout the entire process, starting from Phase 1 clinical trials and extending to regulatory filings.

Essential Duties and Responsibilities:

• Serve as primary PM for the Clinical Development team, including the development and maintenance of strategic plans, timelines, and budgets.
• Develop and administer project status tools (e.g., dashboards, reports, templates, business processes) to assess project team performance.
• Support Compound Development Team Leader to provide PM end support, including communicating key compound risks, and working with the team to mitigate risk factors.
• Lead project and program meetings, study meetings, and clinical team meetings: develop meeting agendas, prioritize topics, and summarize decisions and action items.
• Drive cross-functional communication and decision-making to ensure alignment with internal and external stakeholders.
• Oversee external vendor activities including adherence to timelines, contracts, and budgets, along with invoicing process.
• Work closely with Finance to generate budget forecasts in alignment with Clinical Development Plan.
• Support and collaborate with other cross-functional teams as needed.

Educational and Experience Requirements:

• Expertise in a functional area directly contributing to successful mid to late-stage drug development
• BA/BS in a scientific field plus 8-10 years of pharmaceutical/clinical development experience, including a minimum of 5-6 years of project/program management experience
• Phase 1/2 Clinical study experience highly preferred
• Knowledge of the drug development process
  Familiarity with FDA and/or EMA Regulations, ICH Guidelines, and GCP governing clinical development activities.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, SharePoint)
  Experience with Project Management Software (SmartSheet, MS Project, ThinkCell, and OfficeTimeline)
• Effective troubleshooting and problem-solving skills
• Excellent oral and written communication skills
• Be an effective team player and strong individual contributor, flexible, and able to handle multiple tasks and deliver high-quality results under tight timelines