AD/Director, Clinical Operations
Company: IGM Biosciences, Inc.
Location: Mountain View
Posted on: September 21, 2022
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
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
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
--- Provides consistent, regular oversight of CRO and vendor
--- 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
--- Contributes to and engages Clinical Operations staff in process
development, innovative problem solving, training initiatives as
--- Travel may be required up to 20% in support of clinical study
--- Directly supervises employee(s). Indirectly supervises
employee(s) through a dotted line structure or via other
--- 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
--- 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
--- 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
--- 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
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
--- 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
Didn't find what you're looking for? Search again!