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Senior Director, Clinical Operations Autoimmunity

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.IGM Biosciences is pioneering a new class of antibody medicines for the treatment of cancer, autoimmune/inflammatory diseases, and infectious diseases. Building upon the greater binding power provided by the naturally occurring IgM antibody structure, as compared with the commonly used IgG antibodies, IGM has been able to create “super antibodies” with the potential to generate novel therapeutic options and hope for patients.The company has created a proprietary IgM antibody technology platform that is particularly well-suited for engaging T cells, agonizing receptors via cross-linking, targeting cytokines, and neutralizing pathogenic infectious agents. Currently in the field of oncology, IGM has clinical stage programs for the treatment of solid and hematological malignancies, and IGM is also developing high affinity, high avidity IgM antibodies for the prevention and treatment of patients with autoimmune and inflammatory diseases.The Sr. Director Clinical Operations AI develops and implements strategic direction in the conduct of multiple clinical studies. She/he will oversee the conduct of clinical trials in accordance with the protocols, company SOPs, GCP and other applicable regulatory requirements, and leading and directing Clinical Operations teams in the management of contract research organizations (CROs) and other trial vendors. Autoimmunity experience is required. The Director contributes Clinical Operations expertise in cross-functional meetings and initiatives. Management and mentoring of Clinical Operations staff is expected.Qualifications:· Bachelor’s degree or equivalent is required· Ideal candidate will have at least 15 years of relevant trial leadership 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 autoimmunity 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.· 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\nOne of our top priorities is to maintain the health and wellbeing of our employees and their families. To achieve this goal, we are offering robust and comprehensive benefits with a variety of options:· Medical, dental, and vision insurance. The full premium amount for our employees and their dependents is currently covered by IGM· STD, LTD, Basic Life and AD&D Insurance, Supplemental Life and AD&D Insurance· 401(k) Plan· 120 hours of Paid Time Off, 5 sick days per year, 10 holidays· Cell phone & internet subsidy· Employee Referral Bonus Program· Annual training budget for professional development· Commuter Benefit· Annual bonus program· New hire stock options IGM is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. All qualified applicants will receive consideration for employment.

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

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