Senior / Principal Clinical Scientist, Clinical Development

Immunome
  • Bothell, Washington
  • $145,823–$182,019 Per Year
17 days ago

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 accepted by the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; and IM-3050, a clinical-stage FAP-targeted radioligand therapy. 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 - $200,742USD

E/E/O

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

E-Verify

Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).

Numbers & Facts

LocationBothell, Washington
Salary$145,823–$182,019 Per Year

Skills

  • Analysis Skillsunmatched
  • Analysis Softwareunmatched
  • Antibodiesunmatched
  • Biologyunmatched
  • Biotech and Pharmaceuticalunmatched
  • Cancerunmatched
  • Case Report Form (CRF)unmatched
  • Clinical Dataunmatched
  • Clinical Practices/Protocolsunmatched
  • Clinical Researchunmatched
  • Clinical Trialunmatched
  • Communication Skillsunmatched
  • Cross-Functionalunmatched
  • Data Analysisunmatched
  • Data Qualityunmatched
  • Detail Orientedunmatched
  • Diversityunmatched
  • Drug Developmentunmatched
  • English Languageunmatched
  • FDA (Food and Drug Administration)unmatched
  • GCP (Good Clinical Practices)unmatched
  • ICH Regulationsunmatched
  • Informed Consentunmatched
  • Leadershipunmatched
  • Mentoringunmatched
  • Oncologyunmatched
  • Organizational Skillsunmatched
  • People Managementunmatched
  • Problem Solving Skillsunmatched
  • Project/Program Managementunmatched
  • Publicationsunmatched
  • Regulationsunmatched
  • Regulatory Reportsunmatched
  • Regulatory Requirementsunmatched
  • Regulatory Submissionsunmatched
  • Research & Development (R&D)unmatched
  • Site Initiationunmatched
  • Strategic Planningunmatched
  • Team Playerunmatched
  • Willing to Travelunmatched

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