Senior / Principal Clinical Scientist, Clinical Development
Company Overview
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
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).