Senior / Principal Clinical Scientist, Clinical Development
About The Position
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. 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.
Requirements
- 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.
Nice To Haves
- 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.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
