Senior / Principal Clinical Scientist, Clinical Development

Immunome, Inc.; Bothell (WA); On-site; USD 145,823 - 200,742; Full time

Job summary

Immunome, Inc. in Bothell, Washington, seeks a Senior / Principal Clinical Scientist in Clinical Development to lead design, execution, and interpretation of oncology trials across programs.

You will collaborate with clinical operations, regulatory affairs, and R&D to advance multiple candidates. The role requires a PhD/MD/PharmD/MS with at least 2 years in clinical science or development, strong leadership, and excellent communication.

Qualifications

• PhD/MD/PharmD/MS in life sciences
• Minimum 2 years of clinical science/clinical development experience in biotech/oncology
• Strong leadership, project management, and communication skills

Responsibilities

• Oversee execution of clinical trials with scientific and regulatory rigor
• Design multiple trial protocols and informed consent forms
• Collaborate with investigators and sites; serve as Lead Clinical Scientist for multiple trials
• Generate and validate data; review CRFs and queries
• Prepare clinical study reports, regulatory submissions, and publications
• Support training and SIV/Investigator meetings; assist on DMC activities
• Mentor junior team members and potentially manage direct reports

Job description

Senior / Principal Clinical Scientist, Clinical Development

Bothell, Washington, United States

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-stage ROR1 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.

Knowledge and Skills

• 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. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.