Immunome, Inc.

Immunome, Inc.

Senior / Principal Clinical Scientist, Clinical Development

Bothell, Washington, United States · Principal

Sponsorship not specifiedDetected 1 day ago
GCPData AnalysisProject ManagementClinical TrialsClinical ResearchFDA RegulatoryResearchExperimental DesignLeadershipCommunicationRegulatory Affairs

About the role

  • 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

  • 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.
  • 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.
  • Mentor and develop junior team members with potential to manage direct reports.
  • Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies.
  • 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.

Requirements

  • PhD, MD, PharmD, MS, or equivalent degree in life sciences.
  • Travel may be required.
  • Knowledge and Skills
  • Extensive experience in clinical trial data analysis software and tools.
  • Strong understanding of regulatory requirements and guidelines for clinical trials (e.g., GCP, ICH, FDA).
  • Strong leadership, project management, and communication skills.
  • Extensive experience in drug development process, study design, clinical operations.
  • Strong knowledge and skills to support program specific data review, trend identification, and data interpretation.
  • Excellent analytical, organizational, and communication skills. <span data-ccp-props="{"13

Nice to have

  • 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.

Company info

  • 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.
  • We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.
  • We are seeking a highly motivated and experienced Clinical Scientist to join our team.
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