Description

You will lead the implementation, execution, and oversight of clinical trials within a clinical program, collaborating with cross-functional teams to ensure trials are on time, within budget, and GCP-compliant. This role involves managing timelines, budgets, risks, and mentoring Clinical Trial Managers.

Requirements

• B.S./B.A. in Life Science or related field required; advanced degree preferred
• 9+ years industry experience in clinical development with 3+ years managerial experience (or 4+ with master's)
• 1+ years ophthalmology trial experience and late phase trial experience
• Proven ability to recruit, retain, organize, and motivate clinical operations personnel
• Ability to communicate updates and advocate for budget and resources
• Ability to manage programs with corporate-wide impact
• Ability to develop and manage budgets
• Self-motivating with attention to detail
• Strong interpersonal skills
• Thorough knowledge of FDA and ICH Guidelines, GCP, medical terminology
• Flexibility and adaptability
• Excellent communication and summarization skills
• Ability to present complex information
• 20% travel required

Responsibilities

• Partner with Director of Clinical Operations to develop and manage clinical programs
• Provide operational leadership for planning, execution, and interpretation of clinical trials
• Provide guidance and mentoring to Clinical Trial Managers and junior team members
• Oversee day-to-day activities of Clinical Trial Operations and Clinical Data Management groups
• Collaborate with Finance on annual budget planning and quarterly reviews
• Ensure each clinical trial is inspection ready and actively managed by a Study Execution Team
• Collaborate with Quality to maintain inspection readiness
• Collaborate with Regulatory Affairs and Clinical Sciences on regulatory submissions
• Address escalated study issues and develop risk mitigation plans
• Coordinate development and maintenance of clinical SOPs
• Support development and review of protocols, amendments, and study documents
• Participate in CRO, site, and vendor selection and oversight
• Contribute to Clinical Operations department processes and procedures