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Director / Sr. Director, Clinical Operations
2 months ago
AboutIGM Biosciences, Inc.
IGM Biosciences (Nasdaq:IGMS) is a clinical-stage biotechnology company committed to developing and delivering a new class of medicines to treat patients with cancer and autoimmune and inflammatory diseases. The Company’s pipeline of clinical and preclinical assets is based on the IgM antibody, which has 10 binding sites, compared to conventional IgG antibodies with only 2 binding sites. We have created unique IgM antibodies with high selectivity, affinity, and avidity that may redefine what is possible for therapeutic antibody medicines. We believe our proprietary IgM antibody technology platform is particularly well suited for developing T cell engagers and receptor cross-linking agonists. The Company also has an exclusive worldwide collaboration agreement with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists against oncology, immunology, and inflammation targets. For more information, please visitwww.igmbio.com.
IgM Antibodies and Autoimmune and Inflammatory Diseases
Antibody treatments have revolutionized outcomes for patients with autoimmune and inflammatory diseases. We are committed to exploring how our IgM antibody platform's unique structure and binding propertiescan improve outcomes for patients with these serious conditions.
IgM Antibodies and Oncology
The potential of our IgM antibodies drives our focus on oncology. Leveraging the power of avidity and the strong and durable binding of our IgM antibodies, we are developing new treatment options for cancer patients. Our initial efforts in this field are centered around the broad application of IgM antibodies to activate receptors, triggering the programmed death of cancer cells.
The Director / Sr. Director of Clinical Operations significantly influences our organization, shaping and executing strategic direction in managing multiple clinical studies. This position plays a crucial part in ensuring the successful conduct of clinical trials in adherence to the protocols, company SOPs, GCP, and other relevant regulatory requirements, underscoring our steadfast commitment to industry regulations and standards. The Director's leadership in managing Clinical Operations teams, contract research organizations (CROs), and other trial vendors, as well as tactical contributions of Clinical Operations expertise in cross-functional senior leadership meetings and initiatives, are highly valued. The role's significance is further underscored by the expectation of managing and mentoring Clinical Operations staff through example.
Responsibilities:- Provide leadership and oversight in all aspects of clinical operations, from planning and executing programmatic and project oversight.
- 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, timelines, and critical study activities.
- Develop and maintain enrollment and budget forecasts.
- Manage CROs and third-party vendors to ensure delivery against the contracted scope of work and budget.
- Participate in selecting CRO and vendors, including developing RFPs, budget negotiations, and management.
- Develop and Finalize ICFs, protocols/amendments, IB, site budget/CTA, and contribute to IND filings.
- Oversee and project manage individual studies and relevant program-related activities with minimal supervision, including managing cross-functional team meetings (Agendas, Minutes, Action Items, Follow-up).
- Develop and review SOP processes and guidelines for compliance with global regulatory requirements.
- Ensure development study plans and provide adequate oversight of vendor oversight, risk, safety, and communication.
- Supervise, coach, mentor, and hire new staff.
- Proactively identify risks and develop and implement mitigation strategies.
- Ensure timely and effective risk mitigation and escalation for projects and programs.
- Motivate and inspire others while thriving in a fast-paced, start-up environment.
- Plan, participate, and facilitate operational-level governance with vendors as appropriate.
- Provide senior leadership with project and program updates.
- Partner with cross-functional peers & staff to build execution plans & meet critical business milestones
- Able to travel (