Associate Director, Clinical Operations

What You'll Be Doing

• Develops and maintains the clinical trial deliverables including timelines, budgets, and resource requirements within a therapeutic area
• Attends and supports the clinical sub team
• Provides matrix management of cross functional representatives to manage clinical execution deliverables
• Defines and manages accountabilities for CTT team members
• Reviews and refines Clinical Operations plans for each study
• Develops and constructs content for risk mitigation plans related to the study to ensure clinical trials are on time and within budget
• Implements clinical trial ensuring that clinical trials are conducted in a timely fashion and compliant with SOPs, GCP, and regulatory guidelines, company goals, and budgets
• Partners with clinical development and cross functions to draft the Clinical Protocols, Investigator’s Brochures (IBs), Case Report Forms (CRFs), Informed Consent Forms (ICFs), and Clinical Study Reports (CSRs), and manages timelines for completion of these documents
• May lead selection process for outsourced activities
• Leads the selection of specialty vendors (if needed) including development of scope of services agreements, budgets, and plans and timelines
• Manages CRO/vendor agreements, ensuring that change orders and budgets meet Clinical Operations specifications
• Reviews 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
• Manages 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
• Participates in patient identification activities and the development of patient recruitment plans and back-up plans
• Identifies, recruits, and approves clinical investigators in collaboration with Medical Monitor and Clinical Operations leadership
• Ensures that all supportive study-related documents are completed (e.g. Monitoring Plan, IXRS, Study Reference Manual, Laboratory Manual, Pharmacy Manual, CRF Completion Guideline, etc.)
• Ensures 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
• Ensures quality of data generated from clinical sites and assists in resolving patient eligibility and protocol deviation issues
• Manages internal supporting staff to ensure that all activities are moving according to trial timeline
• Recommends and implements innovative process ideas that impact clinical trials and/or clinical program management
• Participates in the development of Clinical Operations quality systems, including SOPs, document management, Clinical Operations personnel training, and quality control processes
• Contributes to wider organizational goals and/or activities as assigned
• Manages Clinical Operations personnel, including hiring, training, coaching, and performance reviews
• Must be able to travel
• It is imperative that REGENXBIO employees embody our core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives.

We set our employees up for success. To be successful in this role and help us achieve our goals, we are looking for someone with the following skills and qualifications:

• Possess a combination of educational and work experience demonstrating competencies to perform the duties and responsibilities of the position
• Minimum of 8 years’ progressive experience in Clinical Operations with thorough understanding of cross functional clinical processes including clinical supply, data management, biostatistics, and medical writing
• At least 5 years in clinical project management
• Experience in managing cross functional team members during trial execution
• Basic understanding of country level regulations, ICH and GCP guidelines required
• Strong knowledge in GCP and ICH and of the application process to conduct clinical trials
• Ability to function in a fast pace, dynamic environment
• Ability to deal with ambiguity
• Ability to clearly develop action plans to ensure delivery on company strategy and goals as well as clinical development plans
• Strong interpersonal and negotiation skills
• Proven complex problem solving and decision making skills
• 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
• Bachelor’s degree in biological science preferred