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 Program Manager to successfully manage and execute one or more clinical trials/programs with minimal supervision, starting from First in Human Phase I studies, primarily conducted in the U.S and primarily in Oncology indications. Must be able to manage all clinical operational aspects of a clinical trial/program from start-up, site selection, enrollment, maintenance, and close-out. Must be attentive to detail and able to contribute to writing study protocols, informed consent forms, study manuals, develop SOPs, etc.

Qualifications:

· Bachelor’s degree or equivalent is required.

· Ideal candidate will have at least 10 years of relevant experience in either sponsor or CRo (at least 4 years clinical trial management experience).

· Strong track record for successful study initiation and execution.

· 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.

· Relevant therapeutic area and Phase I experience highly preferred.

· Experience managing CROs and third-party vendors.

· Experience in Finance Management (Budget Forecasting, Change Order management, etc.).

· Experience working with EDC, CTMS, and eTMF system.

· Strong interpersonal communication skills.

· Excellent cross-functional clinical project management skills.

· Must have exceptional leadership skills, including motivation and delegation.

Responsibilities:

· Provide leadership and oversight in all aspects of clinical operations from planning and executing 1 or more complex oncology clinical trials/programs (site selection, start-up, enrollment, maintenance and close-out).

· 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 and timelines, and critical study activities.

· Develop and maintain enrollment and budget forecast.

· Manage CROs and third-party vendors to ensure delivery against contracted scope of work and budget.

· Participate in selection of CRO and vendors including development of RFPs, budget negotiations and management.

· Develop and Finalize ICFs, protocols/amendments, IB, site budget/CTA and contribute to IND filings.

· Responsible for oversight and project management of individual studies as well as relevant program related activities with minimal supervision including managing team meetings (Agendas, Minutes, Action Items, Follow Up).

· Develop and review SOPs and processes, guidelines for compliance with global regulatory requirements.

· Develop study plans, including vendor oversight, risk, safety, communication.

· Provide supervision, coach and mentoring, and contribute to hiring new staff.

· Proactively identify risks, develop and implement mitigation strategies.

· Self-motivated and able to thrive in a fast-paced, start-up environment.

· Able to travel (<20%)

The typical annual salary range for this full-time position is $150,000 - $180,000, 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.