Apellis Pharmaceuticals

Clinical Research

• The Clinical Trial Manager is responsible for the overall management, planning, implementation, and execution of clinical trial(s) in a fast-paced environment with moderate oversight from the Senior Clinical Trial Managers and/or Associate Director, Clinical Operations.
• Leads and/or assists the trial team to execute and deliver the clinical trial in accordance with the clinical development plan/strategy, budget and timeline.
• Author clinical trial documents and trial-related plans.
• Contributes to and/or approves with oversight, the clinical review of CRFs, CRF completion guidelines, and the data review plan.
• Leads/assists in the identification and selection of investigator sites.
• Responsible for planning, conducting, and presenting during Investigator’s Meetings.
• Provides input and coordinates the delivery of clinical trial supplies in collaboration with Clinical Supply team as escalate issues as appropriate.
• Collaborates with the cross-functional team on selection and management of clinical trial vendors.
• Responsible for providing input to Trial Master File Plan, overseeing Clinical Operations-related documentation, and coordinates with document specialists regarding trial files.
• Manages and triages escalation of trial-related issues and communicates as appropriate with management and other cross-functional areas.
• Leads oversight of CRO activities and other clinical vendors to ensure the quality meets Apellis and regulatory requirements.
• Monitors and manages budget for clinical trial(s) including proposals, contracts, and change orders from CROs and vendors.
• Attend periodic visits to sites and/or CROs to assess progress of trials/protocol compliance.
• Reviews clinical monitoring reports and correspondence related to monitoring visits, identifies issues/trends as available, and provide oversight and/or serve as escalation point to junior team members.
• Collaborate with cross-functional team members to monitor the clinical trial data to ensure timely entry, collection, and identification of data quality issues.
• Provides periodic status reports regarding trial timelines, budget issues, accruals, etc. to management as requested.
• Responsible for managing one or more clinical trial(s).
• Support departmental initiatives and process improvements.
• Provides input and serves as the subject matter expert for the trial during regulatory inspections.
• Other duties and responsibilities as required.

Clinical Trial Manager

Director

• Support implementation of US medical affairs strategy for pegcetacoplan in GA in alignment with global medical affairs strategy and cross-functional US initiatives
• Assist in implementation of insight gathering, congress planning, KOL engagement plan, and US advisory boards
• Collaborate with Field Medical & Global Medical Affairs Strategy to ensure training and resources are available at appropriate times
• Serve as a medical reviewer on commercial and medical product review committees
• Build and maintain relationships with external stakeholders in the Retina/ophthalmology community
• Provide comprehensive training to MSLs and cross-functional partners to enhance their knowledge of data and disease states
• Collaborate with cross functional team on approaches to fill identified data and/or communication gaps in alignment with overall strategic objectives
• Review sponsorship requests to ensure alignment with areas of focus and budget
• Serve as strategic/scientific resource and therapeutic area expert to cross-functional stakeholders

Clinical Trial Manager

Associate Director, Medical Affairs