Clinical Trials Manager

About IGM 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 and immunology, and inflammation targets. For more information, please visit www.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 the unique structure and binding properties of our IgM antibody platform can improve outcomes for patients with these serious conditions.

IgM Antibodies and Oncology

We are applying the power of avidity and the strong and durable binding of our IgM antibodies to create new treatment options for cancer patients. Our initial efforts in oncology are focused on the broad application of IgM antibodies to activate receptors to induce programmed death of cancer cells. 

Position Summary

We seek an experienced Sr. Clinical Trial Manager to manage and execute one or more first-in-human phase 1- 1b global clinical trials in the oncology therapeutic area. The ideal candidate must be able to manage all clinical and operational aspects of one or more clinical trials with minimal supervision.  Deep experience in all global clinical trial management phases is required, including study start-up activities, patient enrollment initiatives, maintenance, and close-out. Must be attentive to detail and able to contribute to writing study protocols, informed consent forms, study manuals, and developing SOPs.

Exemplary communication skills in all forms in a cross-functional collaborative manner are required.

• Provide leadership and oversight in all aspects of clinical operations, from planning and executing 1 or more complex oncology clinical trials (site selection, start-up, enrollment, maintenance, and close-out).
• Provide strategic operational input to Clinical Development Plan (CDP) and project plans.
• Establish study milestones and ensure accurate tracking and reporting of study 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 contributed to IND filings.
• Oversee project management of individual studies and relevant program-related activities with minimal supervision, including managing team meetings (Agendas, Minutes, Action Items, Follow-up).
• Develop and review SOP processes and guidelines for compliance with global regulatory requirements.
• Develop study plans, including vendor oversight, risk, safety, and communication.
• Provide supervision, coaching, and mentoring and contribute to hiring decisions.
• Proactively identify risks and develop and implement mitigation strategies.
• Must be self-motivated and thrive in a fast-paced, small to mid-sized company, start-up environment.
• Able to travel (~20%)

• Level commensurate with experience.
• 10 years of relevant clinical operations experience at either sponsor or CRO companies, with a minimum of 4 years of clinical trial management experience in Oncology.
• Bachelor’s degree or equivalent is required.
• Demonstrable track record for successful study initiation and execution.
• Sound knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE, and other relevant guidelines and regulations.
• Mandatory Phase I - II experience in oncology therapeutic areas.
• CROs and third-party vendor management required.
• Finance Management (Budget Forecasting and Change Order management) experience
• EDC, CTMS, IRT, and eTMF systems experience required
• Must have strong interpersonal and collaboration skills.
• Must have excellent cross-functional clinical project management skills.
• Must have exceptional leadership skills, including delegating tasks and motivating oneself and others.

One of our top priorities is to maintain our employees' and their families' health and well-being. To achieve this goal, we offer comprehensive benefits with a variety of options:

·         Medical, dental, and vision insurance with IGM covering the full premium amount for our employees and their dependents

·         Annual bonus program based on company and individual employee performance

·         HSA (Health Savings Account) or FSA (Flexible Spending Account)

·         STD, LTD, Basic Life and AD&D Insurance, Supplemental Life and AD&D Insurance

·         401(k) Plan with Employer Match

·         3 weeks Paid Time Off, 5 sick days per year, 12 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.

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