The Director, Clinical Programs serves as an advisor to teams executing clinical studies. This position is also responsible for the performance of study sites and clinical vendors. The Director will work with study leads to ensure studies are inspection ready throughout their lifecycle. May serve as function lead when needed.
1. Contributes to integrated development plans.
2. Selects operational model to be applied to a given study.
3. Implements the vendor performance management and broad operational metrics monitoring program.
4. Participates in the maintenance of the Clinical Quality Management System.
5. Conducts regular assessments of cross-functional team resources and external service providers as appropriate.
6. Oversees day-to-day execution activities and implements any training needed to ensure activities are conducted in compliance with company SOPs, performance expectations and pertinent regulations.
7. Coaches function managers/leads and other team members on the use of clinical project management methodology to develop and effectively manage timelines, budgets and resources.
8. Conducts inspection readiness checks and ensures identified issues are resolved.
9. Compiles performance updates for functional area leadership and may present updates to senior leadership team.
10. May supervise Assistants, Associates, Specialists, Managers, Associate Directors
• Bachelor’s degree or higher in health profession, science, engineering or releated field.
• A minimum of 14 years experience in the pharmaceutical industry, including 12 years of relevant clinical research experience, 6 years supervisory experience, and 2 years in a leadership role.
• Excellent written and oral communication skills.
• Strong project management skills and analytical skills
• Strong working knowledge of GCP, ICH guidelines, and regulatory rquirements for clinical trial management
• Excellent organizational skills, integrity, and attention to detail.
• Ability to think proactively, strategically and creatively
• Strong interpersonal skills with ability to work in a team environment as well as independently
• Ability to assimilate new information rapidly, multi-task, and work across multiple projects
• Computer literacy, proficiency in MS Office, MS Project, etc.
• Ability to travel approximately 25%.