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 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 our IgM antibody platform's unique structure and binding properties can 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 (
Qualifications:
Level commensurate with experience
Bachelor’s degree or equivalent is required
Must have at least 15 years of relevant trial leadership experience in either sponsor or CRO.
Phase I-III Global Trial Management experience
Strong track record for successful study initiation and execution
Strong leadership, influence, and tactical execution skills and experience
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
Experience managing CROs and third-party vendors
Experience in Finance Management, including but not limited to Budget Forecasting, Change Order Management
Experience working with EDC, CTMS, and eTMF systems
Strong interpersonal communication skills
Ability to prioritize critical business needs in alignment with corporate strategy is required
Ability to engage in strategic business discussions and craft executive-level communications and materials is required
Must have excellent cross-functional clinical project management skills
Must have exceptional leadership skills, including ability to delegate, influence, motivate, inspire, and develop self and others.
We offer a fast-paced, collaborative, team-based, work environment.
One of our top priorities is to maintain the health and well-being of our employees and their families. To achieve this goal, we offer comprehensive benefits with a variety of options:
Generous Medical, Dental, and Vision plans. IGM covers the full premium amount for our employees and their dependents
Flexible spending account (FSA)
Competitive salary
New hire stock options / RSU’s
Annual bonus program
Annual refresh grants
Employee Stock Purchase Plan
Matching 401(k) Plan with Employer Match
5 sick days
3 weeks of PTO
Employee referral bonus program
Dedicated professional development and training budget
Short and Long-term Disability Insurance
Life insurance (supplemental life and AD&D insurance)
Commuting and parking benefits
Cell phone / internet subsidy
Pet Insurance
EV charging stations
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.
This range reflects the job's characteristics, 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.
Actual individual pay is determined by demonstrated experience and internal equity alignment.
Seniority level
Not Applicable
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Biotechnology
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