Job Summary:
The Director of Clinical Program Management will provide key support to the Clinical Development Team in planning and executing corporate development goals. This role is critical in supporting clinical development activities from early Phase 1 trials through to regulatory submissions.
Essential Duties and Responsibilities:
- Act as the primary Project Manager for the Clinical Development team, overseeing strategic plan creation, timeline development, and budget management.
- Design and implement project tracking tools (e.g., dashboards, reports, templates, business processes) to monitor team performance.
- Support the Compound Development Team Leader by communicating key compound risks and collaborating with the team to address potential issues.
- Lead and organize various project, program, and clinical meetings, setting agendas, prioritizing topics, and recording decisions and action items.
- Foster cross-functional communication and decision-making to ensure alignment with both internal and external stakeholders.
- Manage external vendor activities, ensuring timelines, contracts, budgets, and invoicing adhere to set guidelines.
- Collaborate with Finance to create budget forecasts that align with the Clinical Development Plan.
- Provide support to and coordinate with other cross-functional teams as necessary.
Educational and Experience Requirements:
- Proven expertise in an area directly contributing to successful mid- to late-stage drug development.
- Bachelor’s degree (BA/BS) in a scientific field, with 8-10 years of experience in pharmaceutical/clinical development, including 5-6 years in project/program management.
- Preferred experience with Phase 1/2 clinical studies.
- Solid understanding of the drug development process.
- Knowledge of FDA/EMA regulations, ICH Guidelines, and GCP standards governing clinical development.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, SharePoint).
- Experience with Project Management Software (e.g., SmartSheet, MS Project, ThinkCell, OfficeTimeline).
