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AD/Director, Clinical Operations

Company: IGM Biosciences, Inc.
Location: Mountain View
Posted on: September 21, 2022

Job Description:

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.

The AD/Director, Clinical Operations 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. Oncology experience is required. The Director contributes Clinical Operations expertise in cross-functional meetings and initiatives. Management and mentoring of Clinical Operations staff is expected.


--- Accountable for overall management of multiple clinical trials including:

o providing strategic direction to study teams to meet corporate study goals and timelines;

o oversight of vendor budgets and contracts

o reporting and justification of study metrics, as requested

--- Contributes expertise, ensures consistency, and captures efficiencies in all operational activities pertaining to the execution of clinical trials

--- Partners with relevant IGM Bioscience departments

--- Participates in the selection of Contract Research Organizations (CROs)

--- Provides consistent, regular oversight of CRO and vendor performance.

--- May attend CRO or other vendor meetings such as project kick-off and investigator meetings, quarterly face-to-face meetings, and others as necessary to assure alignment and achievement of study goals

--- Contributes to the development of staffing/resourcing plans

--- May act as designee for the head of Clinical Operations, as appropriate

--- Contributes to and engages Clinical Operations staff in process development, innovative problem solving, training initiatives as needed.

--- Travel may be required up to 20% in support of clinical study activities.

--- Directly supervises employee(s). Indirectly supervises employee(s) through a dotted line structure or via other subordinate supervisors.


--- Bachelors, Masters or PhD or similar

--- Typically requires a minimum of 15 years of related experience and/or combination of experience and education/training.

--- Experience in Biotech/Pharmaceutical industry preferred.

--- Management experience including outsourcing to Contract Research Organizations (CROs).

--- Has extensive experience in relevant industry/profession.

--- Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.

--- Develops technical and/or business solutions to complex problems.

--- Applies advanced practices, technical principles, theories and/or concepts, and contributes to the development of new principles and concepts.

--- Has a comprehensive understanding of current approaches in industry and ability to incorporate them into IGM Bioscience programs

--- Has extensive experience leading multiple projects involving complex issues and decision-making.

--- Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.

--- Develops departmental policies and oversees and/or authorizes their implementation. Establishes organizational policies in a major segment of the company.

--- Has extensive knowledge of other related disciplines.

--- Applies strong analytical and business communication skills

We offer a fast-paced, collaborative, team-based, and family-like work environment.

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

--- Medical, dental and vision insurance.

--- The full premium amount for our employees and their dependents is covered by IGM

--- FSA (Flexible Spending Account)

--- 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, 11 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.

Keywords: IGM Biosciences, Inc., Mountain View , AD/Director, Clinical Operations, Executive , Mountain View, California

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