Director Director Clinical Science

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, 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.

IgM Antibodies and Autoimmune and Inflammatory Diseases

Antibody 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.

IgM Antibodies and Oncology

IGM 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.  

We 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.

Qualifications:

· Advanced scientific or clinical degree preferred (eg PhD, PharmD, MPH, MD, RN, etc).

· 12+ years experience, at least 7 of which in clinical trials

· Data listing review experience.

· Experience authoring experimental protocols and/or study results and conclusions.

· Relevant Autoimmunity therapeutic area experience.

· In-depth understanding of Phase I (and beyond) drug development.

· Experience in the principles and techniques of data analysis, interpretation.

· 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.

· Proven abilities to perform Clinical Scientist responsibilities with increasing expertise and independence.

· Track record of working well with other scientists and clinicians is highly valued.

· Able to travel (<20%).

Responsibilities:

· Participate in development teams, and clinical trial teams.

· Work with Clinical Development, Clinical Operations, Drug Safety, Biostatistics, Regulatory, and Biomarker groups.

· Develop clinical strategies.

· Lead clinical trial protocol development, and amendments.

· Literature research and review in disease/program area.

· Assist with completion and submission of regulatory filings and other regulatory documentation.

· Work with clinical teams on study site visits, and protocol training.

· Contribute to Investigator Meetings, and Investigator/study calls.

· 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.

· Assist with Medical monitoring inquiries, and participates in safety meetings and tracks, analyzes and reports any potential safety events.

· Work with Medical Directors, Clinical Operations, Biostatistics, and other groups to conduct clinical review of study data.

· Review, analyze, and discuss clinical study reporting documents with Medical Directors.

· Slide deck preparation for communicating clinical development plans, clinical trial timelines, clinical data.

· Support Medical Directors in preparing for internal/external meetings and presentations.

· Drafting and/or reviews of abstracts, posters, and coordinates further reviews with internal partners and stakeholders.

The typical annual salary range for this full-time position is $195,000 - $245,000, plus eligibility for cash and equity incentives.

This 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.

Actual individual pay is determined by demonstrated experience and internal equity alignment.

We offer a fast-paced, collaborative, team-based and family-like work environment. It is one of our biggest goals to maintain our company culture.

One 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:

Medical, dental and vision insurance. The full premium amount for our employees and their dependents is covered by IGM

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, 10 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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