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Immunome, Inc.
Senior / Principal Clinical Scientist, Clinical Development
Career Insights for Clinical Trial Manager
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What they do
A Clinical Trial Manager is responsible for planning and managing all aspects of an organization's program of clinical trials, usually for an organization undertaking pharmacological drug testing.
$159,477 / year median in Washington
Job Description
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been submitted to the
U.S. FDA
; IM-1021, a clinical-stageROR1 ADC
; IM-3050, an IND-cleared FAP-targeted radiotherapy; and IM-1617, an IND-cleared solid tumor ADC. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets. Position Overview We are seeking a highly motivated and experienced Clinical Scientist to join our team. The Senior / Principal Clinical Scientist, Clinical Development will play a critical role in the design, execution, and interpretation of multiple clinical trials for our oncology drug candidates. This individual will work closely with cross-functional teams, including clinical operations, regulatory affairs, and research and development, to ensure the successful progression of multiple clinical programs. Responsibilities Oversee the execution of clinical trials and ensure scientific and regulatory rigor. Design and develop multiple clinical trial protocols, informed consent forms, and other study-related documents. Collaborate with principal investigators, key opinion leaders, and clinical trial sites to ensure robust study design and execution. Serve as Lead Clinical Scientist for multiple trials. Conduct activities related to data generation and validation, including CRF design and clinical data review/query resolution. Contribute to the preparation of clinical study reports, regulatory submissions, and publications. Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities. Perform site-facing activities such as training and responding to clinical questions. Participate in the strategic development of clinical development plans and timelines. Present clinical trial data and findings to internal and external stakeholders, including scientific advisory boards and regulatory agencies. Mentor and develop junior team members with potential to manage direct reports. Qualifications PhD, MD, PharmD, MS, or equivalent degree in life sciences. A minimum of 2 years of experience in clinical science, clinical research, or equivalent; clinical development experience is required, biopharmaceutical/biotechnology industry and oncology experience preferred. Strong leadership, project management, and communication skills. Travel may be required. Knowledge and Skills Extensive experience in drug development process, study design, clinical operations. Extensive experience in clinical trial data analysis software and tools. Strong knowledge and skills to support program specific data review, trend identification, and data interpretation. Strong understanding of regulatory requirements and guidelines for clinical trials (e.g., GCP, ICH, FDA). Excellent analytical, organizational, and communication skills. Ability to work effectively in a fast-paced, collaborative environment. Strong problem-solving skills and attention to detail.WA State Range:
Senior Clinical Scientist, Clinical Development- $ 145,823
- $182,019
WA State Range:
Principal Clinical Scientist, Clinical Development- $ 169,883
- $200,742 Washington State Pay Range $145,823
- $200,742 USD E/E/O Immunome, Inc.