\nAbout IGM Biosciences, Inc.\n\n\nIGM 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.\n \nIgM Antibodies and Autoimmune and Inflammatory Diseases\nAntibody 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.\n \nIgM Antibodies and Oncology\nWe 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. \n\n\nPosition Summary\nWe 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.\n \nExemplary communication skills in all forms in a cross-functional collaborative manner are required. \n\n\n\nResponsibilities:\n* 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).\n* Provide strategic operational input to Clinical Development Plan (CDP) and project plans.\n* Establish study milestones and ensure accurate tracking and reporting of study metrics, timelines, and critical study activities.\n* Develop and maintain enrollment and budget forecasts.\n* Manage CROs and third-party vendors to ensure delivery against the contracted scope of work and budget.\n* Participate in selecting CRO and vendors, including developing RFPs, budget negotiations, and management.\n* Develop and Finalize ICFs, protocols/amendments, IB, site budget/CTA, and contributed to IND filings.\n* Oversee project management of individual studies and relevant program-related activities with minimal supervision, including managing team meetings (Agendas, Minutes, Action Items, Follow-up).\n* Develop and review SOP processes and guidelines for compliance with global regulatory requirements.\n* Develop study plans, including vendor oversight, risk, safety, and communication.\n* Provide supervision, coaching, and mentoring and contribute to hiring decisions.\n* Proactively identify risks and develop and implement mitigation strategies.\n* Must be self-motivated and thrive in a fast-paced, small to mid-sized company, start-up environment.\n* Able to travel (~20%)\n\n\n\nQualifications:\n* Level commensurate with experience.\n* 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. \n* Bachelor’s degree or equivalent is required.\n* Demonstrable track record for successful study initiation and execution.\n* 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.\n* Mandatory Phase I - II experience in oncology therapeutic areas. \n* CROs and third-party vendor management required.\n* Finance Management (Budget Forecasting and Change Order management) experience\n* EDC, CTMS, IRT, and eTMF systems experience required\n* Must have strong interpersonal and collaboration skills.\n* Must have excellent cross-functional clinical project management skills.\n* Must have exceptional leadership skills, including delegating tasks and motivating oneself and others. \n\n\n\n\n$151,000 - $189,000 a yearLevel commensurate with experience.\nThis range reflects the characteristics of the job, such as required skills and qualifications, and is based on the office location noted in this job posting. The range may also be adjusted based on the applicant's geographic location.\n\nOne 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:\n \n·         Medical, dental, and vision insurance with IGM covering the full premium amount for our employees and their dependents\n·         Annual bonus program based on company and individual employee performance\n·         HSA (Health Savings Account) or FSA (Flexible Spending Account)\n·         STD, LTD, Basic Life and AD&D Insurance, Supplemental Life and AD&D Insurance\n·         401(k) Plan with Employer Match\n·         3 weeks Paid Time Off, 5 sick days per year, 12 holidays\n·         Cell phone & internet subsidy\n·         Employee Referral Bonus Program\n·         Annual training budget for professional development\n·         Commuter Benefit\n·         Annual bonus program\n·         New hire stock options\n \nIGM 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.
\n\n#Benefits\n 💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nRemote - USA

\nAbout IGM Biosciences, Inc.\n\n\nIGM Biosciences (Nasdaq: IGMS) is a clinical-stage biotechnology company committed to developing and delivering a new class of medicines to treat patients with cancer, infectious diseases, 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 a proprietary IgM antibody technology platform that we believe is particularly well suited for developing T cell engagers, receptor cross-linking agonists, targeted cytokines, and target neutralizers. 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.\n\n\nIgM Antibodies and Autoimmune and Inflammatory Diseases\nAntibody treatments have revolutionized outcomes for patients with autoimmune and inflammatory diseases, and IgMs are the first antibody defense against a pathogen infection.  We are committed to exploring how the unique structure and binding properties of our IgM platform can improve outcomes for patients with these serious conditions.\n\n\nIgM Antibodies and Oncology\nIGM Biosciences has a T cell engager program, a receptor cross-linking agonist program and a targeted cytokine program in clinical studies for the treatment of patients with solid tumors and hematological malignancies.  \n\n\nWe are seeking an experienced Clinical scientist with experience in Oncology clinical trials to successfully strategize and execute a clinical development plan for engineered IgM-based pipeline molecules, starting from early phase clinical trials studies through to Proof-of-Concept studies and beyond. IGM is committed to exploring the application of IgM antibodies as therapeutics in Immunology, Oncology/Hematology, and Infectious Diseases.\n\n\nQualifications:\n\n\n· Advanced scientific or clinical degree preferred (eg PhD, PharmD, MPH, MD, RN, etc).\n· 12+ years experience, at least 7 of which in clinical trials\n· Data listing review experience.\n· Experience authoring experimental protocols and/or study results and conclusions.\n· Relevant Autoimmunity therapeutic area experience.\n· In-depth understanding of Phase I (and beyond) drug development.\n· Experience in the principles and techniques of data analysis, interpretation.\n· 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.\n· Proven abilities to perform Clinical Scientist responsibilities with increasing expertise and independence.\n· Track record of working well with other scientists and clinicians is highly valued.\n· Able to travel (<20%).\n\n\nResponsibilities:\n\n\n· Participate in development teams, and clinical trial teams.\n· Work with Clinical Development, Clinical Operations, Drug Safety, Biostatistics, Regulatory, and Biomarker groups.\n· Develop clinical strategies.\n· Lead clinical trial protocol development, and amendments.\n· Literature research and review in disease/program area.\n· Assist with completion and submission of regulatory filings and other regulatory documentation.\n· Work with clinical teams on study site visits, and protocol training.\n· Contribute to Investigator Meetings, and Investigator/study calls.\n· Work with Clinical Operations and Medical Directors to develop consistent language and criteria for the Informed Consent Form (ICF), protocol eligibility, protocol dose modification, protocol safety, Case Report Forms (CRFs), CRF instructions, etc.\n· Assist with Medical monitoring inquiries, and participates in safety meetings and tracks, analyzes and reports any potential safety events.\n· Work with Medical Directors, Clinical Operations, Biostatistics, and other groups to conduct clinical review of study data.\n· Review, analyze, and discuss clinical study reporting documents with Medical Directors.\n· Slide deck preparation for communicating clinical development plans, clinical trial timelines, clinical data.\n· Support Medical Directors in preparing for internal/external meetings and presentations.\n· Drafting and/or reviews of abstracts, posters, and coordinates further reviews with internal partners and stakeholders.\n\n\nThe typical annual salary range for this full-time position is $195,000 - $245,000, plus eligibility for cash and equity incentives.\n\n\nThis range reflects the characteristics of the job, such as required skills and qualifications, and is based on the office location noted in this job posting. The range may also be adjusted based on the applicant's geographic location.\n\n\nActual individual pay is determined by demonstrated experience and internal equity alignment.\n\n\n\n\n\nWe offer a fast-paced, collaborative, team-based and family-like work environment. It is one of our biggest goals to maintain our company culture.\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:\n \nMedical, dental and vision insurance. The full premium amount for our employees and their dependents is covered by IGM\nSTD, LTD, Basic Life and AD&D Insurance, Supplemental Life and AD&D Insurance\n401(k) Plan\n120 hours of Paid Time Off, 5 sick days per year, 10 holidays\nCell phone & internet subsidy\nEmployee Referral Bonus Program\nAnnual training budget for professional development\nCommuter Benefit\nAnnual bonus program\nNew hire stock options\n \nIGM 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.\n 
\n\n#Benefits\n 💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nRemote - CA