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Clinical Program Manager, Autoimmunity (Contract)

IGM Biosciences (Nasdaq: IGMS) is a clinical-stage biotechnology company pioneering the development of engineered IgM antibodies for the treatment of cancer, infectious diseases, and autoimmune and inflammatory diseases. IgM antibodies have inherent properties that we believe may enable them to bind more strongly to targets on the surface of cells than comparable IgG antibodies. We believe our proprietary IgM antibody technology platform is particularly well suited for developing T cell engagers, receptor cross-linking agonists, targeted cytokines, and target neutralizers. Our lead product candidate, Imvotamab, is a bispecific T cell engaging IgM antibody targeting CD20 and CD3 proteins, and it is currently in two Phase 2 clinical trials for the treatment of relapsed and/or refractory diffuse large B cell lymphoma and follicular lymphoma. Our second product candidate is IGM-8444, an IgM antibody targeting Death Receptor 5 (DR5) for the treatment of patients with relapsed and/or refractory solid and hematologic malignancies, and it is currently in a Phase 1 clinical trial. Also in our product pipeline is IGM-7354 and IGM-2644. IGM-7354 is an anti-PD-L1 IgM antibody that targets the delivery of interleukin-15 (IL-15) cytokines to the area of PD-L1 expressing cells for the treatment of patients with solid and hematologic malignancies. IGM-2644 is a bispecific T cell engaging IgM antibody targeting CD38 and CD3 proteins for the treatment of patients with multiple myeloma.We are seeking an experienced Clinical Program Manager to successfully manage and execute one or more clinical programs with minimal supervision, starting from First in Human Phase I studies, primarily in autoimmunity indication encompassing diseases such as lupus and rheumatoid arthritis. Must be able to manage all clinical operational aspects of a clinical program from start-up, site selection, enrollment, maintenance, and close-out. Must be attentive to detail and able to contribute to writing study protocols, informed consent forms, study manuals, develop SOPs, etc.Qualifications:· Bachelor’s degree or equivalent is required.· Ideal candidate will have at least 10 years of relevant trial/program management experience in either sponsor or CRO· Strong track record for successful study initiation and execution.· Sound knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations.· Relevant therapeutic area in autoimmunity and Phase IB experience highly preferred.· Experience managing CROs and third-party vendors.· Experience in Finance Management (Budget Forecasting, Change Order management, etc.).· Experience working with EDC, CTMS, and eTMF system.· Strong interpersonal communication skills.· Excellent cross-functional clinical project management skills.· Must have exceptional leadership skills, including motivation and delegation.Responsibilities:· Provide leadership and oversight in all aspects of clinical operations from planning and executing 1 or more complex oncology clinical programs (site selection, start-up, enrollment, maintenance and close-out).· Provide strategic operational input to Clinical Development Plan (CDP) and project plans.· Establish study/program milestones and ensure accurate tracking and reporting of study/program metrics and timelines, and critical study activities.· Develop and maintain enrollment and budget forecast.· Manage CROs and third-party vendors to ensure delivery against contracted scope of work and budget.· Participate in selection of CRO and vendors including development of RFPs, budget negotiations and management.· Develop and Finalize ICFs, protocols/amendments, IB, site budget/CTA and contribute to IND filings.· Responsible for oversight and project management of individual studies as well as relevant program related activities with minimal supervision including managing team meetings (Agendas, Minutes, Action Items, Follow Up).· Develop and review SOPs and processes, guidelines for compliance with global regulatory requirements.· Develop study plans, including vendor oversight, risk, safety, communication.· Perform protocol level feasibility for recruitment rates and determination of study barrier, if any.· Provide supervision, coach and mentoring and contribute to hiring new staff.· Proactively identify risks, develop and implement mitigation strategies.· Self-motivated and able to thrive in a fast-paced, start-up environment.· Able to travel (<20%)\n\n

Job Type
Full Time
Salary
N/A
Experience
N/A
Posted
9 days ago

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