AD, Clinical Operations (Contract)

The role

The Associate Director, Clinical Operations will implement, execute, and oversee clinical trials within a clinical program. This role involves coordinating with cross-functional project teams to ensure trials are completed on time, within budget, and in compliance with GCP and other regulations.

What you will do

• Partner with Director of Clinical Operations to develop and manage clinical programs
• Provide operational leadership for the direction, planning, execution and interpretation of clinical trials
• Provide guidance and mentoring to Clinical Trial Managers and junior level team members
• Independently oversee day-to-day activities of Clinical Trial Operations and Clinical Data Management groups
• Collaborate with Finance/Business Operations on budget planning and vendor outsourcing strategy
• Ensure each clinical trial is inspection ready
• Ensure each clinical trial is actively managed by a cross-functional Study Execution Team
• Collaborate with Regulatory Affairs and Clinical Sciences on regulatory submissions
• Address escalated study issues in collaboration with CTMs and senior management
• Coordinate the development and maintenance of clinical SOPs

Required qualifications

• B.S./B.A. in Life Science or related discipline
• B.S./B.A. with 9+ years of industry experience in clinical development with a minimum of 3 years managerial experience, or M.A./M.S. with 4+ years of experience
• 1+ years ophthalmology trial experience
• Late phase trial experience
• Relevant experience in clinical trial execution across all phases
• Proven ability to recruit, retain, organize, and motivate clinical operations personnel
• Ability to manage and oversee programs that have corporate-wide impact
• Ability to develop and manage functional and clinical trial-specific budgets
• Thorough knowledge and understanding of FDA and ICH Guidelines, GCP, medical terminology, and clinical trials
• Excellent communication and interpersonal skills
• Must be able to write clearly and summarize information effectively
• Must be able to present complex information to various audiences

Nice to have

• Advanced degree (M.S./M.A., MPH, MHS, MBA)
• Clinical Research certification

About the company

4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics. The company's lead product candidate 4D-150 is designed to provide multi-year sustained delivery of anti-VEGF biologics for retinal vascular diseases.