Overview. Long term interest in New Product Planning. Join a high growth clinical-stage biotechnology company focused on the development of immunotherapies for the treatment of inflammatory diseases and cancer. Lead market research and analytics projects, uncover insights, and shape the direction of the company. Join us at a critical time as we enter into phase 3 with other products in a robust pipeline and become the 3rd hire on a growing commer...
Overview. Celldex is a high growth clinical-stage biotechnology company focused on the development of immunotherapies for the treatment of inflammatory diseases and cancer. Celldex has validated pipeline programs, an experienced management team who pioneered early antibody technologies, and support from leading healthcare investors. At Celldex, you’ll work with some of the industry’s most talented scientists and business professionals in a meanin...
Overview. The Regulatory Affairs Coordinator will integrate with the RA team and provide general support as needed under the guidance of RA colleagues. This is an exciting opportunity with potential for growth. The internship will be based out of the New Haven, CT office. Responsibilities. Manage accessible inventory of history of health authority interactions. Provide submission support as needed. Support document publishing. Track Regulatory Af...
Overview. The Operations Manager (OM) will serve as the line manager for Clinical Trial Associates (CTA) as the team expands. This role will support the development and management of clinical operations supporting processes improvement, change management, and operational excellence. The OM will be responsible for performance management of the CTA team and ensuring access to the appropriate training, technology, and development opportunities. Resp...
Overview. Summer internship opportunity to be part of a team of laboratory scientists performing bioanalytical assays, cell culture, and other assorted studies. This is a paid internship located at the Fall River, MA facility. Responsibilities. Participate in the development, optimization, and validation of immunoassays (e.g., ELISA, MSD) under non-GLP and GLP (Good Laboratory Practice) to support Celldex's pipeline. Participate in the receipt pr...
Overview. Celldex is a clinical stage biotechnology company leading the science at the intersection of mast cell biology and the development of transformative therapeutics for patients. Our pipeline includes antibody-based therapeutics which have the ability to engage the human immune system and/or directly affect critical pathways to improve the lives of patients with severe inflammatory, allergic and autoimmune and other devastating diseases. ....
Overview. This position of Associate Manager/ Manager External Clinical Supplies will oversee on-going and new clinical trial supply planning, distribution of drug to clinical sites and budget management while adhering to Good Manufacturing Practices, company policies and procedures. This individual shall support the Contract Manufacturing Organization providing oversight of aseptic drug product manufacturing. Responsibilities. Support outsourced...
Overview. The Director, Health Economics & Outcomes Research (HEOR) will proactively help design and actively implement the integrated HEOR strategies and tactics to support the clinical development and commercialization of barzolvolimab. The incumbent is expected to have the knowledge and skills to design and execute a range of studies, health economics models and other HEOR activities including but not limited to comparative effectiveness stu...
Overview. We work within a highly entrepreneurial environment where personal effort and contributions are rewarded and where communication and teamwork occur every day. Medical writing to include but not limited to annual reports, Investigator's Brochures, protocols/amendments, CSRs, manuscripts, regulatory submissions that reference/summarize clinical data. Researches, writes and edits pre-clinical and/or clinical reports, summarizing data fr...
Overview. Join a well-established and collaborative Clinical Operations team in a Clinical Trial Manager role with opportunity for career enrichment. As the operational leader of the study team, the Clinical Trial Manager (CTM) works closely with internal team members and vendors ensuring clinical trials are completed according to protocol, SOPs, ICH/GCP/regulatory guidelines, and company goals while ensuring timely delivery and budget adherence....
Overview. The Head of Pharmacovigilance and Risk Management provides strategic leadership and tactical oversight of the clinical safety department. Serves as subject matter expert for all medical and safety needs. Oversee submission for safety reports, interacts with regulatory authorities, monitors safety across all programs. Reports to the CMO. Responsibilities. Global management of departmental operations (resourcing, operating procedures, tra...
Overview. The Analytical Development Intern will perform routine laboratory activities and be exposed to the analytical method development and characterization of biotherapeutics. The intern will learn and eventually assist in routine analytical method development and testing. This is a paid internship located at the Fall River, MA facility. Responsibilities. Buffer and solution preparation. Stocking / maintaining inventory of laboratory consumab...
