Associate Director, Clinical Operations

Who we are

REGENXBIO is an exceptional place to work. You'll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans. Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do. We aim to bring these values to life every day with all that we do, and we believe that what we do matters - to patients, to their families, and to their communities.

The opportunity 

You’ll be responsible for the planning and implementation of one or more clinical trials within the ophthalmology therapeutic area.  You’ll execute the clinical trial operational plans to meet the overall development strategy and ensure that clinical trials are conducted in a timely fashion and compliant with Standard Operating Procedures (SOPs), Good Clinical Practices (GCP) and regulatory guidelines, company goals, and budgets.  Also, you’ll manage the day-to-day execution of the trial(s) and ensure the execution is meeting the operational plans and company goals.  

• 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
• Must be able to travel 0-25% of the time

• It is imperative that REGENXBIO employees embody our core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives

• 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
• Experience in creating clinical operations strategy for clinical and product development plan independently with foresight of cross functional needs/risks/mitigations
• 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
• Program level and clinical strategy experience both across the product life cycle and multiple therapeutic areas, including global drug development experience, preferred

Why Should You Apply?

By joining REGENXBIO, you will have the opportunity to be a part of a growing company and incredible team passionate about developing novel AAV gene therapy products to our patients.

We offer a comprehensive and competitive benefit plan which includes market-competitive salaries, an annual bonus program, education assistance, retirement plan with employer match, stock options at all levels, summer hours and more!

In addition, professional development is important to us.  By joining our team, you’ll have the opportunity to be exposed to challenging projects and development resources to help you grow personally and professionally.