Apellis Pharmaceuticals

Director

• Establishes the clinical science competency built on a positive organizational culture grounded in clinical scientific expertise.
• Manages a team of Clinical Scientists (across all levels). Ultimately responsible for leading multidisciplinary teams in the design, planning, execution, and interpretation of clinical development plans across all stages of development.
• Represents Clinical Development in leadership and governance meetings/committees.
• Partners with therapeutic area Medical Directors and R&D colleagues to advance drug development, clinical design strategy, and program prioritization across R&D portfolio of programs.
• Leads and supports cross-functional clinical development teams, represents clinical development on program teams, and liaises as needed with project teams.
• Builds credible relationships with external partners (e.g., principal investigators, key opinion leaders) and represents the company to relevant health authorities and consultant/advisory meetings.
• Builds and manage a strong Clinical Scientist team with responsibility for establishing the team strategy, resource planning, talent development, and management.
• Performs Clinical Scientist responsibilities on key programs as needed.
• Remains up to date on current regulations, guidelines, and scientific advances relevant to Apellis.
• Facilitates cross-functional collaboration with Translational Medicine to transition research stage assets to clinical development.
• Manages Clinical Scientists in the timely and thorough review of study data using best practices and available tools to identify and evaluate trends.
• Participates in due diligence activities as requested.
• Leads non-study cross functional activities or initiatives.
• Travel to field sites, internal and external meetings, and conferences as needed.

Senior Director, Clinical Science

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

• 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

Senior Director, Clinical Science

Clinical Trial Manager

Associate Director, Medical Affairs