Associate Director, Clinical Operations

Summary

Join REGENXBIO, an exceptional workplace, and contribute to the planning and implementation of clinical trials in ophthalmology. You will execute clinical trial operational plans, ensuring timely completion and compliance. Responsibilities include developing clinical trial deliverables, managing cross-functional teams, and overseeing vendor relationships. The role requires a Bachelor's degree, at least 10 years of clinical operations experience, and strong leadership and problem-solving skills. REGENXBIO offers a comprehensive rewards package including competitive salary, bonus program, stock grants, and benefits such as health insurance, retirement plan, and summer hours. Professional development opportunities are also provided.

Requirements

• Bachelor’s degree required, preferably in biological science
• At least 10 years’ experience in clinical operations with significant clinical trial experience globally, potentially spanning trial execution (in varying indications and molecules) across PhI – PhIII
• Ability to problem solve and address risks independently, while communicating to the necessary parties’ solutions with any outcomes needed for resolution
• Ability to create clinical operations strategies leveraging creative ways of dealing with minimal historical knowledge in gene therapy trial design, infusing innovation in design and execution strategies, influencing calculated risks to meet unmet patient need
• Proven experience leading delivery through collaboration with internal organization and external vendors
• Ability to motivate team members and build cross functional teams in support of core team vision to obtain company goals/objectives
• Ability to provide strong leadership and facilitation skills to link strategic direction to align with operational plan
• Ability to deal with ambiguity, and work in a dynamic, fast paced environment
• Ability to quickly adapt to changes that surface in program or project planning
• Must be a demonstrated self-starter and team player with strong interpersonal skills
• Excellent written and verbal skills
• Must display strong analytical and problem-solving skills
• Strong attention to detail
• Must be able to travel 0-25% of the time

Responsibilities

• Develop and maintain the clinical trial deliverables including timelines, budgets, and resource requirements within a therapeutic area
• Attend and support the clinical sub team
• Provide matrix management of cross functional representatives to manage clinical execution deliverables
• Define and manage accountabilities for CTT team members
• Review and refine clinical operations plans for each study
• Develop and construct content for risk mitigation plans related to the study to ensure clinical trials are on time and within budget
• Ensure that clinical trials are conducted in a timely fashion and compliant with SOPs, GCP, and regulatory guidelines, company goals, and budgets
• Partner with clinical development and cross-functional teams to draft the Clinical Protocols, Investigator’s Brochures (IBs), Case Report Forms (CRFs), Informed Consent Forms (ICFs), and Clinical Study Reports (CSRs), and manage timelines for completion of these documents
• May lead selection process for outsourced activities
• Lead the selection of specialty vendors (as needed) including development of scope of services agreements, budgets, and plans and timelines
• Manage CRO/vendor agreements, ensuring that change orders and budgets meet clinical operations specifications
• Review invoices for accuracy compared to operational plans, budgets, and work known to be performed by CRO/vendors
• Lead ongoing review of data to ensure quality and consistency through study execution
• Manage CRO/vendors to achieve goals and ensures that performance expectations are met
• Responsible for working with the CRO to plan everything from early engagement for protocol feedback to database lock
• Participate in patient identification activities and the development of patient recruitment plans
• Identify, recruit, and approve clinical investigators in collaboration with Medical Monitor and Clinical Operations leadership
• Ensure that all supportive study-related documents are completed (e.g. Monitoring Plan, IXRS, Study Reference Manual, Laboratory Manual, Pharmacy Manual, CRF Completion Guideline, etc.)
• Ensure that all monitoring activities and processes are complete, including training of internal and external resources, and are compliant with SOPs and GCP/ICH/regulatory guidelines
• Ensure data quality generated from clinical sites and assist in resolving patient eligibility or protocol deviation issues
• Manage internal supporting staff to ensure that all activities are moving according to trial timeline(s)
• Recommend and implement innovative process ideas that impact clinical trials and/or clinical program management
• Participate in the development of clinical operations quality systems, including SOPs, document management, clinical operations personnel training, and quality control processes
• Contribute to wider organizational goals and/or activities as assigned
• Manage clinical operations personnel, including hiring, training, coaching, and performance reviews

Preferred Qualifications

Program level and clinical strategy experience both across the product life cycle and multiple therapeutic areas, including global drug development experience, preferred

Benefits

• Market-competitive base salary
• Annual performance-based bonus program
• Stock grants at all levels
• Health, dental, and vision insurance
• Retirement plan with 401(k) match
• Summer hours
• Professional development