The Director Trial Master File (TMF) and Clinical Documentation spearheads the vision and strategy for records management of clinical trial documents. They are accountable for leadership of the TMF organization, including technology and systems, TMF Operations, TMF inspection readiness, outsourcing and vendor governance. In this pivotal role, Director TMF and Clinical Doc

Apellis is seeking a Senior Director, Medical Writing (MW) to lead the MW, editing, and clinical publishing groups in support of a variety of regulatory areas including CMC and non clinical, but primarily clinical. This role reports directly to the SVP, Development Operations. Key Responsibilities Include Responsible for managing the MW department budget, strategic planni

As part of the MSAT team, the Senior Manager of Drug Product Manufacturing Science and Technology, will manage tech transfer and process validation at contract drug product manufacturing sites. The Senior Manager of Drug Product MSAT is responsible for drug product process tech transfer, scale up, PPQ, and monitoring and optimization of the manufacturing process for the v

The Associate Director in Program Management supports the One Program Team model and Early Stage Program Lead(s) by ensuring delivery of tasks and deliverables executed with both internal and external partners according to program specifications incl. budget, timelines, and scope. This role will support strategic end to end program requirements and offer novel solutions t

The Associate Director of Biostatistics acts as statistical lead for multiple clinical studies and/or a clinical development program. The successful candidate will provide leadership and guidance on designing studies, selecting appropriate and innovative statistical methods, analyses, interpretation, and reporting of study results. Participates in regulatory interactions

The main responsibilities of this role are to participate in regulatory projects to achieve program deliverables and provide regulatory support to global clinical trial teams or other cross functional teams. This individual will work closely with the Global Regulatory Lead for the assigned program(s) to ensure clear, consistent, and accurate regulatory guidance is provide

Leading, initiating, reviewing and approving strategies for non promotional and promotional materials to comply with regulatory requirements worldwide throughout the product life cycle. The candidate will be responsible for ensuring compliance with regulatory agencies requirements and meeting Apellis' strategic promotional, medical, and corporate communications objectives

The Associate Director of Clinical Pharmacology will have a key role in advancing our growing pipeline. The ideal candidate will champion the use of clinical pharmacology expertise and model informed drug development (MIDD) strategies to enhance the development of novel therapies across all phases of R&D and therapeutic areas, including neurology, ophthalmology, and rare

Apellis is looking to hire a driven and knowledgeable Senior Manager, Investor Relations to join the Finance team. Reporting into the SVP of Investor Relations & Strategic Finance, this individual is responsible for supporting a variety of investor relations initiatives, including being a point of contact for the investment community. Key Responsibilities Include Assist i

The Associate Director of Medical Affairs, Ophthalmology is a key member of the medical affairs team who will work closely with medical affairs and cross functional stakeholders to implement key aspects of the US strategy for ophthalmology and pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age related macular degeneration (AMD). The successful can

The Director of Global Medical Affairs Strategy, Ophthalmology is a key member of the global medical affairs team who will work closely with medical affairs and cross functional stakeholders to implement key aspects of the global medical affairs strategy for ophthalmology. The successful candidate will drive strategic execution across medical affairs activities, which may

The Associate Director, Ophthalmology is a key member of the Global Medical Affairs team who will work closely with medical affairs and cross functional stakeholders to implement key aspects of the Global Medical strategy for ophthalmology and potential global launches of pegcetacoplan in geographic atrophy (GA) secondary to age related macular degeneration (AMD). These a

The Associate Director, Clinical Operations is responsible for the strategic, operational, and financial oversight of their assigned clinical development program(s) and associated clinical trial(s) as well as the line management and professional development of their direct reports. The Associate Director, Clinical Operations contributes to a culture of collaboration and l

The Field Reimbursement Manager (FRM) helps minimize access & reimbursement barriers for patients and providers to optimize access to Apellis' Ophthalmology portfolio. Within their geography, the FRM is responsible for addressing access barriers by strategically working with customers and accounts to solve the most complex patient access issues through all facets of the r

Apellis is seeking an experienced and talented business professional for the role of Associate Director, Strategic Accounts. This role represents an excellent opportunity to make a significant impact working with key Retina physician practices and large consolidated Retina and Ophthalmology accounts for a recent ophthalmic commercial launch at Apellis. The Associate Direc