Department: Regulatory Affairs Reports to: Director, Regulatory Affairs Location: Office US-based Other responsibilities: Participates in the preparation of documentation packages for regulatory submissions (including IND, CTA, etc.) to the FDA and other regulatory agencies. Formats, edits, coordinates and reviews regulatory documentation for inclusion in INDs, CTAs, and other worldwide submissions. Compiles documentation for submissions to FDA and foreign […]
Reporting into the Chief Medical Officer, the Director of Biostatsitics is a full-time position for an established biostatistician with experience in pre-clinical and clinical trials statistical analysis and modeling. The ideal candidate will provide statistical leadership and will be joining an enthusiastic and growing team of clinicians, scientists and immune-oncology drug development experts. The candidate will provide statistical oversight for clinical protocol development, regulatory interactions, data assessment and assistance with pre-clinical and biomarker immune analyses. This is an opportunity for the ideal candidate to establish a new Biostatistics program within the company and contribute to the drug development strategy at Replimune. Replimune, Inc. is a biotechnology company focused on oncolytic virus drug development for the treatment of cancer. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.
As a member of the Replimune Clinical Development management team, the Clinical Development Operations Director will support the clinical development programs for the Replimune clinical studies. The Director, Clinical Development Operations will provide leadership, project management, and program oversight to plan and conduct one or more high quality clinical trials concurrently in accordance with CFR, EMA, and ICH GCP regulations in support of regulatory authority submissions. The Director, Clinical Development will manage all operational aspects of clinical development projects.
Department: Quality Systems Reports to: Director, Quality Systems Location: Framingham, MA Summary of job description: Reporting to the Director of Quality Systems, this position will be responsible for the management of quality systems at all Replimune locations. This position will be located at the Framingham, MA location. Key responsibilities: Support day-to-day operations of the Quality Systems […]
Department: Quality Assurance Reports to: Director, Quality Assurance Location: Framingham, MA Office (US-based ) Summary of job description: Ensures the administration of the quality and GxP process efforts of the Replimune Framingham facility. Work with cross functional teams to maintain and present the internal quality systems associated with GxP activities to ensure the successful and timely release […]
The Sr. Associate, Regulatory Affairs participates in ensuring that all relevant requirements are met for regulatory submissions (including IND, CTA, BLA, etc.) to the FDA and other regulatory agencies. Provides support in the further development, implementation and maintenance of Regulatory Affairs systems.