Director Of Clinical Program Management

BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Director, Clinical Program Management to work for a leading San Diego Biopharmaceutical company.

Purpose of Position

The Associate Director / Director, 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:

• Drive cross functional communication and decision making to ensure alignment with internal and external stakeholders.
• Lead project and program meetings, study meetings, and clinical team meetings: develop meeting agendas, prioritize topics, summarize decisions, and action items.
• Support and collaborate with other cross-functional teams as needed.
• Serve as primary PM for the Clinical Development team, including development and maintenance of strategic plans, timelines, and budgets.
• Work closely with Finance to generate budget forecasts in alignment with Clinical Development Plan.
• 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 to communicate key compound risks, and working with team to mitigate risk factors.
• Oversee external vendor activities including adherence to timelines, contracts, and budgets, along with invoicing process.

Educational and Experience Requirements:

• Familiarity with FDA and/or EMA Regulations, ICH Guidelines, and GCP governing clinical development activities.
• Expertise in a functional area directly contributing to successful mid to late-stage drug development
• Phase 1/2 Clinical study experience highly preferred
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, SharePoint)
• Effective troubleshooting and problem-solving skills
• BA/BS in a scientific field plus 8-10 years of pharmaceutical/clinical development experience, including a minimum of 5-6 years project/program management experience
• Experience with Project Management Software (SmartSheet, MS Project, ThinkCell, and OfficeTimeline)
• Knowledge of the drug development process
• 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