Apellis Pharmaceuticals, Inc.

Position Summary:. The Associate Clinical Trial Manager is accountable for the management of clinical trial activities including monitoring oversight and ensuring accurate data and document collection. The ACTM proactively identifies, resolves/mitigates and escalates risks and/or issues and may be responsible for clinical trial activities for multiple studies. Responsibilities:. Ensure trial adherence to ICH/GCP/local regulations. Assisting with the development of high-quality monitoring report templates and plans. Ensure country and site selection meet study requirements. Reviewing monitoring... view job details

Position Summary:. We are seeking a talented, motivated, and goal-oriented individual to join our Program Management team. As an Associate Director of Program Management at Apellis, the successful candidate plays an important role in supporting efforts to develop new products and maximize the value of the pipeline.  The individual in this role will serve as Program Manager for one or more development programs. The ideal candidate will have a strong scientific background and experience developing drugs in orphan disease and leverage that experience to play a key leadership role on cross-functio... view job details

Position Summary:. Apellis is looking to hire an experienced Associate Director of Clinical Supply Chain to join the Supply Chain team and to ensure clinical trial supply continuity which will enable Apellis to move our clinical stage programs toward commercialization.  Reporting into Senior Director of Clinical Supply Chain, this role will be focused on ensuring supply continuity for two of Apellis’ on-going Ph3 clinical trials.  Additionally, this role will help drive organizational structure and working standards for Apellis’ growing Clinical Supply Chain capabilities.  A successful candida... view job details

Job Description. Position Summary:. The Associate Director, supports all CMC regulatory affairs activities for the company’s products, summarizes regulatory requirements, provides CMC regulatory input for Health Authority submissions, and manages the compilation and review of CMC sections of all submissions for completeness and quality. Primary Responsibilities:. Provide strategic and tactical support for the timely preparation, editing and review of CMC sections, including regulatory agency meeting materials, IND/CTA amendments, original marketing applications and their respective amendments/... view job details

Apellis is a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade. We believe that our lead product candidate, APL-2, has the potential to be a first-in-class treatment targeting C3 that may address the limitations of existing treatment options or provide a treatment option where there currently is none. APL-2 has already shown activity that we believe is clinically ... view job details

Apellis is a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade. We believe that our lead product candidate, APL-2, has the potential to be a first-in-class treatment targeting C3 that may address the limitations of existing treatment options or provide a treatment option where there currently is none. APL-2 has already shown activity that we believe is clinically ... view job details

Apellis is a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade. We believe that our lead product candidate, APL-2, has the potential to be a first-in-class treatment targeting C3 that may address the limitations of existing treatment options or provide a treatment option where there currently is none. APL-2 has already shown activity that we believe is clinically ... view job details

Apellis is a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade. We believe that our lead product candidate, APL-2, has the potential to be a first-in-class treatment targeting C3 that may address the limitations of existing treatment options or provide a treatment option where there currently is none. APL-2 has already shown activity that we believe is clinically ... view job details

Position Summary:. The Associate Director is responsible for managing the North America and clinical development pharmacovigilance process, supporting the clinical and commercial teams, maintaining compliance with FDA/Health Canada regulations, organization of medical review team meetings, creating and maintaining global and local procedures and documentation and assisting in the oversight of vendor services.. Key Responsibilities Include:. Working with cross-functional team members to ensure efficient and compliant safety data collection from clinical trials and post-marketing surveillance. A... view job details

Apellis is a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade. We believe that our lead product candidate, APL-2, has the potential to be a first-in-class treatment targeting C3 that may address the limitations of existing treatment options or provide a treatment option where there currently is none. APL-2 has already shown activity that we believe is clinically ... view job details