Replimune is a fast paced growing innovative company that is constantly evolving. Likewise, the accounts payable process is evolving from manual paper based processes toward implementing automated system solutions. This role will have end-to-end responsibility for managing the company accounts payable process, including related month-end closing processes, vendor invoice processing, payment distribution, and 3-way match process. Secure all necessary authorizations for payment in support of company policy. Lead the development and implementation of initial Accounts Payable ERP module and ePayables application.
The Clinical Trial Associate (CTA) will be responsible for supporting the clinical operations team. The CTA will participate in clinical activities to support and facilitate the efficient conduct of the clinical research goals. The CTA will report to the Director Clinical Development Operations.
The Manager, of Clinical Outsourcing will play a critical role as part of Replimune’s Clinical Development team. This individual will develop and manage the operational and strategic processes, which support the implementation and management of global clinical outsourcing.
Reporting into the Chief Medical Officer, the Medical Director will be responsible for assisting the CMO in implementing the Replimune drug development strategy and will lead the clinical aspects of individual drug programs. The Medical Director will provide clinical input on clinical protocol development, regulatory issues, patient enrollment to clinical studies, safety monitoring and review, biomarker development, implementation and analysis of data, manuscript writing and submission, and presentation of data at national and international meetings. This position will have both an inward and outward facing presence, including assisting the clinical operations team in the site evaluation and selection process for assigned clinical trials.
Reporting into the Chief Medical Officer, the Medical Writer will be responsible for assisting the CMO, clinical development/operations, regulatory affairs, medical affairs, biostatistics and translational research departments in writing and updating core documents and draft external presentations, as requested. The writer will maintain working knowledge of Replimune strategic plans and provide writing and editorial assistance on various documents, including clinical protocols, Investigator brochures, regulatory documents, clinical study reports, safety reports, biomarker-related documents, scientific abstracts and publications, healthcare provider and patient education materials and other written materials as requested. This position may also interact with external investigators and vendors in drafting and editing investigator-initiated clinical protocols, reports and publications. The position will also have access to pre-clinical data and assist in the drafting and editing of the biomarker-related and pre-clinical study reports, scientific abstracts and peer-reviewed manuscripts.The individual must have the ability to work independently and also as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job.The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.
The procurement manager role will play a key part in supporting and leading the company’s Indirect and Capital sourcing for Replimune. In this newly created role, the ideal candidate will be leveraging proven experience in, negotiation (change management as well as 3rd party contractual agreements), process development, system implementation, P2P process and procedures, along with development and management of the supplier base. They will also be involved in, development and implementation strategies that minimize total cost of ownership (TCO) of Replimunes’ estimated $30M+ spend. In conjunction with developing initial procurement infrastructure; they will perform all current procurement related activities within the current transitional processes (i.e. manual based and semi-automated).
This position will be required to interact with all departments within the company and to proactively support GMP compliance. The role provides an opportunity to enhance quality skills and experience within a GMP environment.
This position provides cross-functional support of GXP activities as they relate to Quality Systems. This position will participate in the improvement of Quality Systems to ensure quality and adherence with current Good Manufacturing Practice (cGMP) and inspection readiness.
The Senior Manufacturing Associate is responsible for executing the cGMP manufacturing operations to support the production of Replimune products at the Framingham, MA, facility. This individual will collaborate with multiple departments to support the manufacturing technology transfer and startup of the production facility and will assist with the generation/revision of Standard Operating Procedures and associated documentation to ensure manufacturing readiness.
The Sr. Clinical Trial Manager (Sr. CTM) is responsible for the planning, implementation and conduct of large, global Phase I-III clinical trials, or multiple smaller early-phase studies. The Sr. CTM is expected to provide leadership and guidance in managing clinical activities at the project level. This includes meeting company and regulatory requirements according to written processes and procedures, timelines, quality and budget.