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).
Skills Required
- Advanced degree (PhD, MD, PharmD, MS, or equivalent) in life sciences.
- Minimum of 2 years experience in clinical science, clinical research, or clinical development.
- Clinical development experience in biopharmaceutical/biotechnology (preferred oncology experience).
- Experience designing and developing clinical trial protocols, informed consent forms, and CRF design.
- Experience with clinical trial data analysis software and tools and clinical data review/query resolution.
- Strong knowledge of regulatory requirements and guidelines for clinical trials (GCP, ICH, FDA).
- Strong leadership, project management, communication skills, and ability to mentor junior team members.
What We Do
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs). Our most advanced pipeline programs are varegacestat (formerly AL102), a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors; IM-1021, a ROR1-targeted ADC which is currently in a Phase 1 trial; and IM-3050, a FAP-targeted radioligand, which recently received IND clearance. Our pipeline also includes IM-1617, IM-1335, and IM-1340, all of which are preclinical ADCs pursuing undisclosed targets with expression in multiple solid tumors.
